Reported trial results for Crohn's Disease and Colitis

173 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT04173273 · results posted 1 July 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04173273) tested a medicine called etrasimod, given at two different doses (2 mg and 3 mg), compared to a placebo (a dummy treatment with no active ingredient). The trial was conducted across several sub-studies, involving different groups of participants at different stages — an initial treatment period, an extended treatment period, and a longer-term maintenance phase. In total, across all sub-studies and groups, several hundred participants took part. The largest single sub-study (SS1) began with 100 people on placebo, 98 on etrasimod 2 mg, and 97 on etrasimod 3 mg during the induction (initial) period. A smaller sub-study (SSA) started with 1 person on placebo, 42 on etrasimod 2 mg, and 41 on etrasimod 3 mg. Additional groups continued into extended and maintenance phases, with numbers ranging from small groups of around 12–47 participants depending on the sub-study. The reported data shows that in the main induction period (SS1), 87 of the 100 placebo participants, 89 of the 98 on etrasimod 2 mg, and 81 of the 97 on etrasimod 3 mg completed that phase. In the smaller SSA sub-study, 1 of 1 placebo, 32 of 42 on etrasimod 2 mg, and 36 of 41 on etrasimod 3 mg completed the induction period. In the longer-term maintenance phase (SS3), the reported data shows that of those who had responded to treatment and continued, completion numbers varied by group — for example, 29 of 38 completed in one etrasimod 2 mg group, and 17 of 28 in one etrasimod 3 mg group. The reported data shows that outcome measure numbers for the primary and secondary endpoints themselves were not included in the structured data provided, and therefore those specific results cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04779307 · results posted 30 April 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04779307) enrolled 121 children and teenagers with ulcerative colitis — a condition causing ongoing inflammation of the large bowel. Participants received the medicine vedolizumab, with the dose adjusted to their body weight: 150 mg for those weighing 10–15 kg (3 participants), 200 mg for those weighing over 15 kg up to 30 kg (27 participants), and 300 mg for those weighing 30 kg or more (91 participants). The trial was measuring how many participants reached "clinical remission" — meaning their bowel symptoms and bowel-lining appearance on camera (endoscopy) had improved to near-normal levels — at two time points: around 14 weeks (roughly 3 months) and 54 weeks (roughly one year). The reported data shows that at the 14-week mark, roughly 33% of the lightest weight group, 44% of the middle weight group, and 32% of the heaviest weight group had reached clinical remission. By 54 weeks, participants had been re-grouped into a "low dose" group (47 participants) and a "high dose" group (46 participants) for the maintenance phase. The reported data shows that at 54 weeks, about 51% of the low-dose group and about 44% of the high-dose group were in clinical remission. For participants who had already reached remission at 14 weeks and were then checked again at 54 weeks (called "sustained remission"), approximately 30% of the low-dose group and 28% of the high-dose group maintained that remission. Looking at endoscopy results specifically, around 36% of the low-dose group and 30% of the high-dose group showed sustained improvement in their bowel lining at 54 weeks, while endoscopic response (any measurable improvement on camera) at 54 weeks was reported at about 60% for the low-dose group and 48% for the high-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03827109 · results posted 13 January 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 285 participants across five groups: 55 children in a mentoring program, 56 children in an educational activity program, 55 parents linked to the mentoring program, 56 parents linked to the educational activity program, and 63 mentors. The trial was measuring quality of life and everyday functional ability in young people, comparing those who took part in a mentoring program against those who took part in an educational activity program. Quality of life was measured using a tool called the PedsQL — a questionnaire scored from 0 to 100, where higher scores mean better quality of life. Everyday functional ability was measured using the Functional Disability Inventory, scored from 0 to 60, where higher scores indicate greater difficulty with daily activities. The reported data shows that, for all six primary outcome measures — including quality of life scores at 12 and 18 months, changes from the starting point, physical quality of life, and functional disability at both time points — the recorded values for both the mentoring group and the educational activity group were listed as zero participants. This means that no outcome measurement data appears to have been submitted for these measures in the ClinicalTrials.gov results. It is worth noting that completion data was only recorded for the two child groups (40 in the mentoring group and 39 in the educational activity program), while the parent and mentor groups all showed zero completions in the reported figures. The reported data does not allow any conclusions to be drawn about what the program achieved, as the actual outcome scores were not provided in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04987307 · results posted 13 January 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 221 adults across four groups to test a medicine called efavaleukin alfa for ulcerative colitis, a condition that causes inflammation in the large bowel. Participants were randomly assigned to receive either a dummy treatment (placebo) or one of three doses of efavaleukin alfa — 400, 1,100, or 1,800 micrograms — given every two weeks. The main thing the trial was measuring was the proportion of participants who reached "clinical remission" (meaning their symptoms and bowel inflammation had reduced to a low, defined level) by week 12. The study was terminated early, and not all participants completed it. The reported data shows that for the primary measure — clinical remission at week 12 — approximately 7.5% of those in the placebo group met the criteria, compared with 9.8%, 9.6%, and 10.4% in the three efavaleukin alfa dose groups respectively. For the secondary measures, the reported data shows that clinical response (a meaningful reduction in symptoms and inflammation score) at week 12 was recorded in around 20.8% of the placebo group and 19.6%, 25.0%, and 25.0% of the three dose groups. Symptomatic remission (fewer bowel movements and no rectal bleeding) was seen in 15.1% of the placebo group versus 17.6%, 23.1%, and 22.9% in the dose groups. For the combined measure of remission in both endoscopy (camera examination) and tissue biopsy results, the figures were 0% for placebo, 7.8% for the lowest dose, 1.9% for the middle dose, and 0% for the highest dose. Changes in tissue inflammation scores on a standardised scale showed small reductions across all groups, with the placebo group showing the largest average reduction. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02531126 · results posted 31 December 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT02531126) enrolled 877 people across four groups studying a medicine called ozanimod. The four groups were: a placebo-then-placebo group (184 people), an ozanimod-then-placebo group (196 people), an ozanimod-then-ozanimod group (443 people), and a smaller open-label ozanimod group (54 people) drawn from an earlier related study. The trial was measuring how many participants experienced side effects or unwanted medical events after starting treatment, as well as tracking several markers related to ulcerative colitis symptoms — including whether participants reached "clinical remission" (a combination of little or no bleeding, near-normal bowel frequency, and improved gut lining on camera examination). The reported data shows that, for the primary measure of unwanted medical events (called treatment-emergent adverse events, or TEAEs — meaning any new or worsening health event occurring after the first dose), 139 out of 184 people in the placebo-placebo group experienced at least one such event, compared with 160 out of 196 in the ozanimod-then-placebo group, 342 out of 443 in the ozanimod-then-ozanimod group, and 37 out of 54 in the open-label ozanimod group. Of these, serious events were recorded in 24, 41, 76, and 8 people respectively, and events that led to stopping the study drug occurred in 17, 14, 33, and 4 people respectively. For the secondary measures, the reported data shows that the percentages of participants meeting the definition of clinical remission varied across time points and groups — for example, at one measured time point, figures ranged from around 41.6% in the placebo-placebo group to 62.9% in the ozanimod-then-placebo group and 44.0% in the ozanimod-then-ozanimod group. Similar patterns of variation across groups were reported for clinical response (symptom improvement), visible gut lining improvement on camera, remission without steroid use, and remission confirmed by tissue sample examination, with percentages differing across groups and time points as detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04090411 · results posted 16 December 2025

  According to the results reported on ClinicalTrials.gov, this trial tested a medicine called PF-06480605 in people with ulcerative colitis (a condition causing inflammation in the large bowel). The trial had two stages: an "induction period" of about 14 weeks, where 246 people were randomly assigned to receive either a placebo (a dummy treatment with no active ingredient) or one of three doses of PF-06480605 (50 mg, 150 mg, or 450 mg); and a longer "chronic period," where participants who completed the first stage were reassigned to various dose combinations, with up to 224 people continuing into this phase. The trial measured whether participants reached "clinical remission" — meaning their disease activity score fell to a low level on a standard scale — and also tracked how many people experienced adverse events (unwanted medical occurrences) during the study. The reported data shows that, at week 14, clinical remission was recorded in approximately 11.6% of participants in the placebo group, compared with 25.5% in the 50 mg group, 23.3% in the 150 mg group, and 23.9% in the 450 mg group. Regarding adverse events during the induction period, the number of participants who experienced any adverse event was 25 (placebo), 16 (50 mg), 29 (150 mg), and 49 (450 mg). Serious adverse events — those involving hospitalisation, life-threatening situations, or similar significant medical events — were recorded in 4, 3, 1, and 4 participants in those same groups respectively. No participants in any induction group left the study due to an adverse event. During the chronic period, the reported data shows adverse events continued to be recorded across all dose groups, with serious adverse events ranging from 0 to 5 participants depending on the treatment group; the specific breakdown by group was not reported here in full, but the figures are available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04232553 · results posted 15 December 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04232553) enrolled a total of 996 participants across multiple groups, all of whom received at least one dose of study drug. The trial was measuring outcomes in people with Crohn's disease who had previously taken part in an earlier study (referred to as the "AMAM" study). Participants were assigned to different groups depending on what treatment they had received previously — either mirikizumab (the drug being studied), a placebo (a dummy treatment with no active ingredient), or ustekinumab (another medicine) — and then continued into this follow-on study receiving mirikizumab in one of two ways: either as an injection under the skin (300 mg SC) or starting with a drip into a vein (900 mg IV) before switching to injections. The trial measured things like bowel inflammation visible on camera (endoscopy), disease activity scores, and markers of inflammation in the blood and stool at 52 weeks. The reported data shows the following for the two main (primary) outcomes at week 52. For the camera-based gut inflammation measure (called "endoscopic response," meaning at least a 50% improvement in the gut lining score), the percentages of participants recorded as achieving this ranged widely across the groups: among those who had previously received mirikizumab and continued on the injected dose, 82.1% reached this marker, compared with 29.7% in the drip-then-injection group from the same prior-treatment background. Among participants who had previously received a placebo, the figures were 92.6% and 38.7% respectively; among those who had previously received ustekinumab, 75.0% and 39.7%; and among a separate group of placebo participants, 94.1% and 51.4%. For the second primary outcome — being in "clinical remission" (a standard score below 150 indicating low disease activity) — the reported percentages ranged from 55.9% to 84.9% depending on the group. The reported data also shows secondary measures: a gut lining "remission" score (stricter definition) ranged from 14.2% to 66.3% across groups; a patient-reported symptom response ranged from 63.3% to 97.8%; and two blood and stool inflammation markers (CRP and faecal calprotectin) were also recorded at week 12, with figures varying across groups as detailed in the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05611671 · results posted 15 December 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called MORF-057 in people with ulcerative colitis, a condition that causes inflammation in the large bowel. A total of 280 people took part, split across four groups: one group took MORF-057 at 200 mg twice daily, one took 100 mg twice daily, one took 100 mg once daily in the morning, and one took a placebo (a dummy pill with no active ingredient). The trial's main goal was to measure how many participants reached "clinical remission" — meaning their bowel symptoms and a camera examination of the bowel (endoscopy) both showed very low levels of disease activity — using a standard scoring tool called the Modified Mayo Clinic Score. The reported data shows that, for the primary goal of clinical remission at the end of the study, 31.9% of participants in the 200 mg twice-daily group, 23.9% in the 100 mg twice-daily group, and 17.1% in the 100 mg once-daily group met that definition. In the placebo group, 24.3% of participants also met the remission definition. For a secondary measure — "clinical response," meaning a meaningful improvement in symptoms and endoscopy score compared to the start of the trial — the reported figures were 62.3% for the 200 mg twice-daily group, 53.5% for the 100 mg twice-daily group, 57.1% for the 100 mg once-daily group, and 54.3% for the placebo group. No other outcome data was included in the structured results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05528510 · results posted 9 December 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 418 people across three groups to study a medicine called guselkumab in people with ulcerative colitis. One group of 139 people received a placebo (a dummy treatment with no active ingredient), while the other two groups of 139 and 140 people each received guselkumab but on different dosing schedules. The trial measured things like whether participants reached "clinical remission" — meaning their symptoms and bowel inflammation had settled to very low levels based on standardised scoring tools — at 12 and 24 weeks. The reported data shows that at Week 12, about 6.5% of placebo participants met the definition of clinical remission, compared with about 27.6% of those in the combined guselkumab groups. For symptom-based remission alone (no bleeding and near-normal stool frequency), the reported figures were 20.9% for placebo and 51.3% for the guselkumab groups. When looking at bowel lining improvement on camera (endoscopy), the reported numbers were 12.9% for placebo and 37.3% for guselkumab. For a broader measure called "clinical response" — meaning a meaningful reduction in overall disease scores — 34.5% of the placebo group and 65.6% of the guselkumab group met that threshold. Combined tissue and camera improvement was reported in 10.8% of the placebo group and 30.5% of the guselkumab group. At Week 24, the reported data shows clinical remission rates of 9.4% for the placebo group, 35.3% for the guselkumab group that moved to a lower maintenance dose, and 36.4% for the group that continued on the higher maintenance dose. It is worth noting that more people in the placebo group (52 out of 139) used rescue medication during the study compared with the guselkumab groups (27 and 23 respectively), which the reported data notes but does not fully explain in the submitted figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03440372 · results posted 4 November 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03440372) looked at people with Crohn's disease, a condition causing ongoing inflammation in the digestive tract. A total of 625 participants were enrolled across two treatment groups — 417 in Treatment 1 and 208 in Treatment 2. The trial measured several things at 12 weeks, including symptom scores, bowel movement frequency, abdominal pain, and the appearance of the intestinal lining on camera examination (endoscopy). The reported data shows the following for the primary measure — the proportion of participants whose overall Crohn's disease symptom score (called the CDAI) fell below 150, which researchers used as a marker of low disease activity: 31.3% of participants in Treatment 1 and 20.8% in Treatment 2 reached this level at 12 weeks. For the secondary measures, the reported data shows that 30.5% of Treatment 1 and 21.7% of Treatment 2 participants had low abdominal pain and three or fewer bowel movements per day without their symptoms worsening. Regarding the camera examination of the gut lining, 22.1% of Treatment 1 and 18.4% of Treatment 2 participants showed a reduction in visible inflammation of 50% or more from where they started. When combining both symptom score improvement and gut lining improvement together, 16.6% of Treatment 1 and 13.5% of Treatment 2 participants met both measures at the same time. It is worth noting that the data file contained multiple sets of percentage figures for each outcome measure, and where the figures did not clearly align to a single result per group, only the first set of values reported for each group has been described above; the remaining figures were not explained in the submitted data and have not been included here to avoid misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03464097 · results posted 9 October 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 550 people with Crohn's disease — a condition causing inflammation in the digestive tract. Participants were split into three groups: 188 people who received the study drug ozanimod throughout the trial, 188 who received ozanimod for the first part then switched to a dummy pill (placebo), and 174 who received a placebo the whole time. The trial measured things like disease activity scores, signs of inflammation seen on camera (endoscopy), stomach pain, and bowel habits, mainly at the 52-week (one-year) mark. It is worth noting that a notable number of participants did not complete the study — roughly half in each group. The reported data shows the following for the main measures at week 52. For the first primary outcome — the proportion of participants whose overall disease activity score (a combined measure called CDAI) fell into a low-activity range — 44.2% of those on ozanimod throughout reached that level, compared with 33.1% of those who switched to placebo, and 35.5% of those always on placebo. For the second primary outcome — the proportion whose gut inflammation as seen on camera reduced by at least half from the start — the figures were 24.3%, 17.5%, and 16.4% respectively. For several secondary measures, including combined stomach pain and bowel frequency targets, and disease activity scores while off steroid medicines, the reported percentages ranged from roughly 32% to 51% depending on the group and the specific measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03467958 · results posted 17 September 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03467958) involved people with Crohn's disease, a long-term inflammatory bowel condition. The study was made up of several related parts, with participants across different groups ranging from 13 to 329 people per group. The trial measured ozanimod (0.92 mg) against a placebo (an inactive treatment), tracking disease activity using a scoring tool called the Crohn's Disease Activity Index (CDAI) — essentially a questionnaire covering symptoms like bowel frequency, abdominal pain, and general wellbeing, where a higher score means worse symptoms. A score below 150 was used to define "clinical remission," meaning very low disease activity. The reported data shows that in the main placebo-controlled part of the trial, 19.6% of participants in the placebo group and 21.0% in the ozanimod group reached clinical remission. For measuring a meaningful improvement in symptoms (called "clinical response" — either a score below 150 or a drop of at least 100 points), the reported figures were 26.8% for placebo and 29.2% for ozanimod. In a separate longer-term follow-on part of the study, remission rates were notably higher across all groups, ranging from roughly 56% to 61% among those who completed that phase. The reported data also shows that adverse events (unexpected medical occurrences during the trial) were recorded in 140 out of 179 placebo participants and 247 out of 329 ozanimod participants in the main part; serious adverse events were recorded in 38 and 59 participants respectively in those same groups, though the data does not break down the nature of those events further. Regarding the secondary measure of abdominal pain and stool frequency remission, the reported figures for the main placebo-controlled part were 16.2% (placebo) and 21.3% (ozanimod). In the longer-term follow-on completers, figures ranged from approximately 45% to 53% across groups. Note that completion data for all sub-groups was not fully reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04607837 · results posted 15 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04607837) enrolled 155 people in the etrasimod group and 79 people in the placebo group, for a total of 234 participants. The trial was studying etrasimod as a treatment for ulcerative colitis (a condition causing inflammation of the large bowel). The main thing the trial was measuring was how many participants reached "clinical remission" at 52 weeks — meaning their bowel habit scores, bleeding scores, and gut lining appearance (as seen on camera) all fell within defined low-activity ranges on a scoring tool called the Modified Mayo Score. The reported data shows that, at 52 weeks, 26.0% of participants in the etrasimod group and 18.3% in the placebo group met the definition of clinical remission. For the secondary measures, the reported data shows: at 12 weeks, 28.3% of the etrasimod group and 11.7% of the placebo group met the clinical remission definition. At 52 weeks, 32.3% of the etrasimod group and 23.3% of the placebo group showed improvement in gut lining appearance on camera; 37.0% versus 30.0% met the definition of "symptomatic remission" (low stool frequency and no bleeding); 20.5% versus 20.0% met the stricter "complete symptomatic remission" definition (zero excess stools and no bleeding); and 25.2% versus 15.0% showed combined improvement in both gut lining appearance and tissue samples taken during the procedure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05019742 · results posted 26 June 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05019742) enrolled a very small number of participants — just 3 people in total. They were split across three groups: 2 people received a placebo (a dummy treatment with no active ingredient), 0 people received a 50 mg dose of the study drug SPH3127, and 1 person received a 100 mg dose of SPH3127. The trial was measuring whether participants achieved "clinical remission" (meaning their symptoms improved to a defined level) and "endoscopic remission" (meaning that, when examined internally with a camera, signs of disease had reduced to a defined level) by Day 56 of the study. The reported data shows that, for both the clinical remission and endoscopic remission measures, 0 out of 2 participants in the placebo group and 0 out of 0 participants in the 50 mg group met those targets. The 1 participant in the 100 mg SPH3127 group was reported as achieving both clinical and endoscopic remission. For the secondary outcome — which counted how many participants reported any unwanted health events (called adverse events) during the study — the reported data shows that 2 out of 2 participants in the placebo group reported at least one adverse event, while 0 participants in either of the SPH3127 groups reported any adverse events. It is important to note that with only 3 participants completing this trial, the numbers are extremely small and no broad conclusions can be drawn from them. The reported figures simply reflect what happened with these specific individuals in this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04964297 · results posted 6 June 2025

  According to the results reported on ClinicalTrials.gov, this trial involved a total of three participants, all of whom were in Cohort 1 (the "Predetermined Points Measurement" group). Cohort 2 (the "Continuous Monitoring" group) had no participants start or complete the study. The trial was measuring levels of two gases — methane and hydrogen — in the body, as well as how quickly a medical device called the Perf-Alert™ could detect the presence of these gases. These gases can be produced in the digestive system, and the trial appears to have been exploring how well this device could pick them up. The reported data shows that, for the three participants in Cohort 1, the average measured level of methane gas was 2.62 ppm (parts per million, meaning tiny trace amounts in a sample), and the average level of hydrogen gas was 20.69 ppm. For the secondary outcome, the reported data shows that the Perf-Alert™ device took an average of 12 seconds from when a sample was collected to when its sensors first detected a gas. No results were reported for Cohort 2, as no participants were enrolled in that group. It is worth noting that this was a very small study with only three participants, so the numbers reported here reflect a very limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03466411 · results posted 7 May 2025

  According to the results reported on ClinicalTrials.gov, this trial (known as GALAXI 1, 2, and 3) enrolled a total of 1,409 adults with Crohn's disease across three related sub-studies. Participants were assigned to receive different doses of a medicine called guselkumab (given by drip into a vein and then by injection under the skin), a comparison medicine called ustekinumab, or a placebo (a dummy treatment with no active ingredient). The trial measured disease activity using two main tools: a scoring system based on symptoms called the CDAI (where lower scores mean less disease activity), and a camera examination of the bowel called an endoscopy (where lower scores also mean less disease activity). The studies ran for up to 48 weeks. The reported data shows the following for each sub-study. In GALAXI 1, which looked at change in the CDAI symptom score after 12 weeks, the three guselkumab groups showed average score reductions of approximately 144, 139, and 160 points respectively, while the placebo group showed an average reduction of about 34 points. In GALAXI 2 and GALAXI 3, two key combined outcomes were measured at weeks 12 and 48: first, the proportion of participants who had a meaningful symptom response early on and were then in remission (very low disease activity) by week 48; and second, the proportion who had that same early symptom response and also showed an improvement on bowel camera examination by week 48. In GALAXI 2, the reported figures for these two outcomes were 54.8% and 49.0% for the two guselkumab groups (compared with 11.8% for placebo) for the remission outcome, and 38.4% and 39.2% (compared with 5.3% for placebo) for the endoscopy outcome. In GALAXI 3, the corresponding figures were 48.0% and 46.9% (compared with 12.5% for placebo) for the remission outcome, and 36.0% and 33.6% (compared with 5.6% for placebo) for the endoscopy outcome. A separate regional result for GALAXI 2 reported that 47.1% of the combined guselkumab group had reached very low disease activity by week 12, compared with 22.4% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05470985 · results posted 22 April 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05470985) enrolled a very small number of children and adolescents with Crohn's disease — just 3 participants in the ozanimod 0.46 mg group and 2 in the ozanimod 0.92 mg group during the main double-blind treatment phase. The trial was measuring disease activity using two tools: the Pediatric Crohn's Disease Activity Index (PCDAI), which is a scoring system based on symptoms, growth, and blood tests, and the Simple Endoscopic Score for Crohn's Disease (SES-CD), which measures inflammation seen during a camera examination of the bowel. The trial had a main treatment period and a longer follow-up extension phase. The reported data shows that for the two primary (main) outcome measures — the proportion of participants reaching low disease activity scores on both the PCDAI and the SES-CD at Week 64 — no numerical results were submitted to ClinicalTrials.gov. Similarly, most of the secondary (additional) outcome measures also have no figures recorded. The only numbers reported were for the ozanimod 0.92 mg group at Week 12: 0% of participants in that group reached the PCDAI remission threshold (a score below 10), and 0% achieved a 50% or greater reduction in their endoscopy inflammation score. Data for the 0.46 mg group at Week 12, and results for both groups at Week 64 for the secondary measures, were not reported. It is worth noting that with only 5 participants enrolled in total — an extremely small number — the trial was very limited in scope, and the absence of most reported figures makes it difficult to draw any picture of what was observed across the full study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02620046 · results posted 3 April 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at vedolizumab 108 mg given as a subcutaneous (under-the-skin) injection to people with two types of bowel disease: ulcerative colitis and Crohn's disease. A total of 288 people with ulcerative colitis and 458 people with Crohn's disease started the study. Of those, 125 and 162 respectively completed it, meaning a notable number of participants left the study early. The trial was primarily measuring how often unwanted medical events (called adverse events) occurred during long-term treatment, and also tracked a range of secondary measures including how participants' disease symptoms changed over time. The reported data shows that, for every 100 years of combined patient treatment time, there were 22.9 adverse events among ulcerative colitis participants and 28.0 among Crohn's disease participants. Serious adverse events — meaning those involving hospitalisation, life-threatening situations, lasting disability, or similar significant medical occurrences — were reported at a rate of 6.5 per 100 participant-years for ulcerative colitis and 8.7 for Crohn's disease. For a specific category of closely watched events (such as serious infections, allergic reactions, and liver-related issues), the reported rates were 16.3 per 100 participant-years for ulcerative colitis and 17.4 for Crohn's disease. The reported data also shows that, at Week 48, 168 ulcerative colitis participants met the study's definition of a meaningful reduction in symptoms, and 150 met the definition of low disease activity (remission) based on a standard scoring tool. Among Crohn's disease participants, 217 met the definition of remission and 32 — drawn from a specific subgroup who had left an earlier related study — showed a meaningful reduction in symptoms according to a separate scoring tool. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03591770 · results posted 21 February 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03591770) looked at how well a shingles (herpes zoster) vaccine triggered an immune response in adults with ulcerative colitis (UC) who were on different types of medication. Participants were divided into four groups based on their treatment: those taking tofacitinib alone (3 people), those on anti-TNF medication alone (8 people), those on anti-TNF medication combined with a thiopurine (0 people enrolled), and those on aminosalicylates or no immune-suppressing therapy (4 people). In total, 15 people started the trial. Only 1 participant — from the tofacitinib group — was recorded as completing the study, while the remaining 14 did not complete it. The reported data shows that the primary outcome — measuring changes in the body's immune cell response to the vaccine before and after vaccination using a laboratory test called an ELISPOT (which counts immune cells activated by the vaccine) — has no numerical results listed in the data submitted to ClinicalTrials.gov. In other words, the figures for this key measurement were not reported. For the secondary outcomes, the reported data shows that zero participants in the tofacitinib group, the anti-TNF group, and the aminosalicylates/no-therapy group recorded any vaccine side effects at one month. Only one participant (from the tofacitinib group) had side-effect data recorded at eight months, and that figure was also zero. Regarding disease activity at the time of the study, the reported data shows small numbers of participants across the tofacitinib and anti-TNF groups were classified across the different activity categories (remission, mild, moderate, severe), though the way the figures are presented in the submission makes a clear breakdown difficult to describe precisely. It is worth noting that because so few people enrolled and very few completed the trial, and because the primary outcome numbers were not reported, the data available is very limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05197049 · results posted 21 February 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called guselkumab in people with Crohn's disease, a condition causing ongoing inflammation in the digestive tract. A total of 350 people took part, split into three groups: 118 received a placebo (a dummy treatment with no active ingredient), 117 received guselkumab at one dose combination, and 115 received guselkumab at a second dose combination. The trial measured several things, including whether participants reached "clinical remission" — meaning their disease activity score dropped below a certain level — as well as whether there were signs of improvement seen during a camera examination of the bowel (called endoscopic response). The reported data shows that by week 12, around 56% of participants in the combined guselkumab groups reached clinical remission, compared with around 21% in the placebo group. For the bowel camera measure at week 12, about 41% of the guselkumab group showed a meaningful improvement, compared with about 21% in the placebo group. By week 24, the reported remission figures were approximately 61% and 58% for the two guselkumab dose groups respectively, versus about 21% for placebo. For a separate patient-reported measure at week 12 — based on pain and stool frequency scores — about 49% of the guselkumab group met the target, compared with about 17% in the placebo group. Regarding unwanted medical events recorded up to week 48, the reported data shows these were noted in about 66% of placebo participants, 83% in one guselkumab group, and 80% in the other; the trial did not draw conclusions about the cause of these events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03512327 · results posted 9 January 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants who followed an eating plan called the Autoimmune Protocol (AIP) Diet. All 15 completed the study — none dropped out. The trial was looking at whether this diet was associated with changes in disease activity in people with inflammatory bowel conditions, specifically Crohn's disease and ulcerative colitis. Disease activity was measured using standardised scoring tools: the Harvey Bradshaw Index for Crohn's disease (scored 0–16, where lower scores mean less disease activity) and the Mayo score for ulcerative colitis (scored 0–12, again with lower scores meaning less disease activity). The reported data shows that, among participants with Crohn's disease, 6 reached what the trial defined as clinical remission (a Harvey Bradshaw Index score below 5). Among participants with ulcerative colitis, 5 reached clinical remission (a Mayo score of 2 or less). For the secondary outcomes, 7 out of all participants showed an absence of erosions or ulcers when examined by endoscopy or imaging — a measure the trial called "mucosal healing." The reported data also shows that 9 participants had a change in a blood marker of inflammation called C-reactive protein (CRP) between the start of the study and week 11, and 6 participants had a change in another inflammation marker found in stool, called fecal calprotectin, over the same period. A separate analysis looked at gene activity in bowel tissue samples from ulcerative colitis participants and reported 10 notable biological process categories where gene activity appeared to shift — though the detailed interpretation of this finding was not included in the structured data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03926130 · results posted 27 December 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,158 participants in total — 212 in the placebo group (a dummy treatment with no active ingredient), 631 receiving mirikizumab, 309 receiving ustekinumab (a different medicine used for comparison), and 6 adolescents receiving mirikizumab. Most participants completed the study: 159 in the placebo group, 561 in the mirikizumab group, 271 in the ustekinumab group, and 4 in the adolescent group. The trial was measuring two main things in adults with Crohn's disease: first, whether participants showed an early symptom response by week 12 (fewer loose stools and/or less abdominal pain) and then went on to show reduced inflammation visible on camera examination of the bowel (endoscopic response) by week 52; and second, whether those same early responders went on to reach full remission — meaning their overall disease activity score fell below a set threshold — by week 52. The reported data shows that, for the two primary goals measured in adults comparing mirikizumab to placebo: 38.0% of mirikizumab participants met the combined early-response-then-endoscopic-response target, compared with 9.0% in the placebo group. For the combined early-response-then-remission target, 45.4% of mirikizumab participants reached that point by week 52, compared with 19.6% in the placebo group. For the secondary measures, the reported data shows that at week 12, endoscopic response was recorded in 32.5% of mirikizumab participants versus 12.6% for placebo, and clinical remission at week 12 was reported in 37.7% versus 25.1% respectively. By week 52, endoscopic response was reported in 48.4% of mirikizumab participants, 46.3% of ustekinumab participants, and 9.0% of placebo participants. Full remission at week 52 was reported in 54.1% of mirikizumab participants, 48.4% of ustekinumab participants, and 19.6% of placebo participants. No outcome data for the small adolescent group was included in the reported results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03440385 · results posted 5 December 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called ozanimod in people with Crohn's disease, which is a condition causing ongoing inflammation in the digestive tract. A total of 403 people were assigned to receive ozanimod and 203 people received a placebo (an inactive dummy treatment) — giving roughly 606 participants overall. The trial tracked several measures of disease activity, including a detailed scoring system called the CDAI (which combines things like stool frequency, abdominal pain, and general wellbeing into a single number) as well as a camera-based score of gut inflammation called the SES-CD. The reported data shows that for the main (primary) outcome — the proportion of participants whose CDAI score fell below 150, which is considered a low-activity threshold — 29.8% of people in the ozanimod group reached that point, compared with 30.5% in the placebo group. For the secondary outcomes, the reported figures were similarly close between the two groups: around 29.0% of the ozanimod group versus 26.6% of the placebo group met a separate measure of remission based on abdominal pain and stool frequency alone. When looking at gut inflammation on camera, 25.6% of the ozanimod group showed at least a 50% reduction in their inflammation score, compared with 21.2% in the placebo group. For a combined measure of both symptom improvement and reduced gut inflammation, 16.9% of the ozanimod group and 14.3% of the placebo group met the threshold. Another combined measure showed 11.7% versus 11.3% respectively. The reported data shows that across all the measured outcomes, the percentage differences between the ozanimod and placebo groups were relatively small. No conclusions about whether ozanimod "works" can be drawn from these numbers alone, and this summary does not represent a full analysis of the trial's findings — for example, statistical testing results were not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02403323 · results posted 2 December 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02403323) involved people with Crohn's disease — a condition causing ongoing inflammation in the digestive tract. A total of 751 participants took part across two parts of the study. Part 1 was an open-label extension period, meaning all participants received the study drug, etrolizumab, and knew they were receiving it. Part 2 was a safety monitoring period that did not involve the study drug. The trial was measuring how many participants reached certain disease score thresholds at regular intervals, how many showed improvement on an internal camera examination of the gut (called an endoscopy), and how many participants experienced unwanted medical events (called adverse events) while on the drug. The reported data shows that, looking at two different scoring systems used to assess Crohn's disease activity, the numbers of participants recorded as reaching the remission threshold (low disease activity scores) varied across the check-in points over roughly two years. For example, using one scoring system (CDAI, a composite score based on eight factors), the reported numbers of participants at the remission threshold ranged from 230 at the first check-in down to 73 at the last check-in. Using a second scoring system based on stool frequency and abdominal pain, the numbers ranged from 200 down to 71 across the same time points. At a single endoscopy check point (week 108), 147 participants were reported to have shown at least a 50% reduction in their internal gut inflammation score compared to their starting point. The reported data also shows that 624 out of 751 participants experienced at least one adverse event (an unwanted medical occurrence recorded during the study) during Part 1. Of those, 206 participants experienced a serious adverse event — defined as one that was life-threatening, required hospitalisation, or caused significant disability. Regarding infections specifically, 366 participants were reported to have had at least one infection-related adverse event, with the majority recorded as mild or moderate in severity; 5 participants had a life-threatening infection-related event and 1 participant died from an infection-related adverse event. It is important to note that these numbers describe events that were recorded during the study period and do not, on their own, establish a cause-and-effect relationship with the study drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04033445 · results posted 18 November 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04033445) tested a medicine called guselkumab in people with ulcerative colitis — a condition causing ongoing inflammation in the large bowel. The trial ran in three stages: two early "induction" studies (IS-1 and IS-2) where participants received treatment over the first 12 weeks, followed by a longer "maintenance study" (MS) lasting a further 44 weeks. In total, across all stages, more than 1,000 people took part. The trial measured things like how many people saw a meaningful improvement in their symptoms (called a "clinical response") and how many reached a point where their symptoms were largely gone (called "clinical remission"), using a standardised scoring system called the modified Mayo score, which rates stool frequency, rectal bleeding, and bowel inflammation on a scale of 0 (normal) to 9 (severe). The reported data shows that in Induction Study 1, around 27.6% of participants who received a placebo (a dummy treatment with no active medicine) showed a clinical response at 12 weeks, compared with 61.4% of those who received guselkumab 200 mg and 60.7% of those who received guselkumab 400 mg. For Induction Study 2, which measured clinical remission at 12 weeks, the data was not fully available in the excerpt provided — so those specific numbers cannot be reported here. The maintenance study involved approximately 199–201 participants in each of the three randomly assigned groups (placebo, guselkumab 100 mg every 8 weeks, and guselkumab 200 mg every 4 weeks), plus a further roughly 122–125 participants in non-randomised groups, though the full outcome numbers for that stage were not included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03395184 · results posted 30 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03395184) enrolled 244 participants with Crohn's disease across three groups during an initial 12-week period: 79 received a placebo (a dummy treatment with no active ingredient), 93 received a medicine called ritlecitinib, and 72 received a medicine called brepocitinib. After that initial phase, participants who wished to continue moved into a longer follow-up period of up to 52 weeks, where they received lower doses of one of the two active medicines. The trial was measuring how well each treatment reduced visible signs of Crohn's disease inside the bowel (assessed using a scoring system called SES-CD, which rates ulcers and bowel inflammation on a scale from 0 to 60), as well as tracking laboratory results, heart tracing (ECG) readings, vital signs, and any unwanted medical events that occurred during the longer follow-up phase. The reported data shows that, at the end of the 12-week initial period, 12.8% of participants in the placebo group achieved at least a 50% reduction in their bowel inflammation score, compared with 27.2% in the ritlecitinib group and 33.8% in the brepocitinib group. During the longer follow-up period, the reported data shows that abnormal laboratory test results (meeting pre-specified thresholds) were recorded in 33 out of 36 participants who switched from placebo to ritlecitinib, 76 out of 84 who continued on ritlecitinib, 26 out of 32 who switched from placebo to brepocitinib, and 56 out of 64 who continued on brepocitinib. Regarding unwanted medical events during the follow-up period, 32, 58, 25, and 54 participants (in those same four groups respectively) experienced at least one treatment-emergent adverse event, while serious adverse events were recorded in 6, 10, 5, and 16 participants respectively. No abnormal heart tracing findings were reported in three of the four groups, with one participant in the brepocitinib continuation group having such a finding noted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02118584 · results posted 23 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02118584) involved people with ulcerative colitis — a condition causing inflammation of the large bowel. The trial had two parts. In Part 1, an open-label extension period where all participants received the study drug etrolizumab, 1,026 people started (with 747 of those then moving into Part 2). An additional 49 people joined only for Part 2, a safety monitoring period. The trial was measuring things like how many participants reached "remission" (meaning their disease activity scores fell into a low or minimal range), as well as tracking any unwanted medical events (called adverse events) that occurred during the study. The reported data shows that, when remission was measured using a three-part bowel symptom score (called the partial Mayo Clinic Score), the percentage of participants recorded as being in remission at different time points across Part 1 ranged from about 32% at the earliest check-up up to around 77% at a later point, before sitting at 72% at the final Part 1 time point. When a more detailed four-part score (the full Mayo Clinic Score, which also includes a camera examination of the bowel) was used, 58.1% of participants were reported to be in remission at the relevant assessment. Using only the camera examination result, 45.7% of participants were reported to be in what is called "endoscopic remission" — meaning the bowel lining appeared normal or near-normal on the camera test. The reported data also shows that, out of the 1,026 participants in Part 1, 1,431 adverse events (unwanted medical occurrences, which may or may not be related to the study drug) were recorded across all severity levels. Of these, 373 participants experienced what were classified as serious adverse events — meaning events significant enough to require hospitalisation or that were otherwise considered medically important. Separately, 825 participants had at least one infection-related adverse event recorded, with the majority of those being mild to moderate in severity; 6 participants had a grade 4 (life-threatening) infection-related event, and 1 had a grade 5 event (recorded as death related to an adverse event). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05068284 · results posted 3 October 2024

  According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called ABBV-154 in people with Crohn's disease. The trial involved different groups receiving either a placebo (a dummy treatment with no active ingredient) or ABBV-154 at various doses and delivery methods — some given by drip into a vein (IV) followed by injections under the skin (SC), and at different timing intervals. In total, across all groups and study phases, around 106 people were enrolled. The trial ran in several stages: a 12-week induction phase (initial treatment period), a 12-week re-induction phase for some participants, and a 40-week maintenance phase. The main thing being measured was how many participants showed a meaningful improvement in the appearance of their bowel lining on a camera examination (called an endoscopic response), using a scoring system known as the SES-CD. The reported data shows that for the primary outcome — endoscopic response at 12 weeks — 0 out of 21 participants in the placebo group met the threshold, compared with 1 out of 20 in the lowest ABBV-154 IV/SC dose group, 4 out of 22 in the mid-dose group, 4 out of 20 in the higher every-two-week dose group, and 3 out of 23 in the higher every-four-week dose group. For the secondary outcomes measuring symptom-based remission (using two different scoring tools — the CDAI and the SF/AP criteria), the reported numbers were similarly small across all groups. For example, on the CDAI remission measure, the numbers ranged from 2 participants in the placebo group up to 6 in the mid-dose group. Several secondary outcome measures relating to the maintenance phase were listed but had no data reported, so those results are not available. It is worth noting that the numbers of participants in this trial were quite small across all groups, which is typical of an early-phase trial designed to explore dosing and gather initial data rather than draw firm conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01171807 · results posted 24 September 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 33 children and young people in total — 21 received the active treatment (called Dex 21-P, a form of dexamethasone delivered inside red blood cells) and 12 received a placebo (an inactive treatment). The trial was measuring whether participants responded to treatment, defined as their bowel disease either going into remission or showing a marked improvement, alongside being able to stop or reduce their oral steroid tablets. Several secondary measurements were also taken, including blood markers of inflammation and a score based on what doctors saw during a bowel examination. The reported data shows that, looking at the primary goal, 15 out of 21 participants in the Dex 21-P group met the definition of "responder," compared with 1 out of 12 in the placebo group. Regarding blood cortisol levels (a hormone that can be suppressed by steroid treatments), the reported change from the start of the study was a decrease of 3.3 units (mcg/dL) in the Dex 21-P group and 2.3 units in the placebo group. For inflammation markers in the blood, the erythrocyte sedimentation rate (a measure of inflammation) fell by 4.9 mm/h in the Dex 21-P group and 9.3 mm/h in the placebo group, while C-reactive protein (another inflammation marker) fell by 0.5 mg/L in the Dex 21-P group and 2.2 mg/L in the placebo group. For unwanted medical events (adverse events) not related to steroids, 11 of 21 participants in the Dex 21-P group and 8 of 12 in the placebo group experienced at least one such event during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04877990 · results posted 24 September 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04877990) enrolled people with one of two bowel conditions — Crohn's Disease or Ulcerative Colitis. In the Crohn's Disease group, 26 people started the pre-treatment stage and 24 moved into the treatment stage. In the Ulcerative Colitis group, 41 people started and all 41 moved into the treatment stage. The trial was primarily measuring things related to monitoring participants' wellbeing during treatment, including any unwanted medical events (called adverse events), blood and urine test results, heart tracing (ECG) readings, and vital signs such as blood pressure and pulse. The reported data shows that, when it came to unwanted medical events during treatment, 18 out of 24 Crohn's Disease participants and 19 out of 41 Ulcerative Colitis participants experienced at least one such event. Serious events — meaning those involving hospitalisation, being life-threatening, or similarly significant — were reported for 2 participants in each group. One participant in each group stopped the study due to an unwanted event. Regarding heart tracings (ECGs), some changes from the starting point were recorded — for example, average heart rate changed by about minus 1.4 beats per minute in the Crohn's Disease group and plus 2.6 beats per minute in the Ulcerative Colitis group during one measurement period. The reported data shows that no participants in either group had abnormal blood or urine chemistry results flagged, though some ECG and vital sign abnormalities were noted across both groups. Some laboratory values such as lipid (fat) levels in the blood showed small numerical changes from the starting point, but a number of individual measurements within this outcome were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05082428 · results posted 23 September 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 252 adults who were all receiving tofacitinib (a tablet-form medication) for ulcerative colitis — a condition causing inflammation of the large bowel. All 252 participants completed the study with none dropping out. Rather than testing a new treatment against a placebo, the trial was observational in nature, meaning it was set up to describe the characteristics and disease history of this group of patients at the time they started tofacitinib. The reported data shows that, on average, participants were around 31 years old when they were first diagnosed with ulcerative colitis, and had been living with the condition for approximately 8 years before starting tofacitinib. In terms of how far the bowel inflammation had spread (graded using the "Montreal Classification"), 5 participants had inflammation limited to the rectum only, 67 had it extending to the left side of the bowel, and 180 had more widespread inflammation across the whole colon. At the time tofacitinib was started, participants had an average "Mayo Score" of 7.45 out of 12 — a scoring tool doctors use to measure ulcerative colitis severity, where higher numbers indicate more severe disease. A shortened version of that score (out of 9, not including the camera test result) averaged 4.75. Regarding the camera-based (endoscopy) findings graded by tissue samples, the reported data shows no participants were recorded in the mild or normal categories, and the moderate and severe category figures were listed as not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04071405 · results posted 3 September 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people in Japan who were taking tofacitinib (brand name Xeljanz), a medicine used for certain inflammatory conditions. Three people did not complete the study, leaving 107 in the final safety group. The trial was a post-marketing observational study — meaning it followed people already prescribed the medicine in real-world clinical practice — and its main focus was tracking and recording any medical events (called "adverse events") that occurred while participants were taking the medicine. A subgroup of participants who had been taking the medicine for at least 52 weeks were analysed separately as "long-term users." The reported data shows that across all 107 participants, 40.19% experienced any adverse event of any kind, and 24.30% experienced an adverse event considered to be linked to the medicine (called an adverse drug reaction). More serious events — those involving hospitalisation, life-threatening situations, death, or lasting disability — were recorded in 7.48% of participants, while serious events specifically linked to the medicine were recorded in 0.93% (1 person). Separately, the trial also tracked "unexpected" events — those not already listed in the medicine's official information — and these were recorded in 22.43% of participants for any unexpected event, 12.15% for unexpected drug reactions, and 3.74% for unexpected serious events. No unexpected serious drug reactions were recorded. A small category called "adverse events of special interest" (medical events of particular concern for this specific medicine) was recorded in 1.87% of all participants. Among the long-term users analysed separately, the reported data shows 27 people had any adverse event, 18 had an adverse drug reaction, 3 had a serious adverse event, and none had a serious adverse drug reaction. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04613518 · results posted 12 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04613518) looked at a drug called BMS-986165 (also known as deucravacitinib) in people with ulcerative colitis, a condition causing inflammation of the large bowel. A total of 38 people took part in the double-blind phase — 26 received the higher dose (12 mg twice daily), 4 received the lower dose (6 mg twice daily), and 8 received a placebo (a dummy treatment with no active ingredient). The trial measured whether participants showed a meaningful improvement in their bowel disease symptoms by week 12, using a scoring system called the modified Mayo score, which tracks stool frequency, rectal bleeding, and bowel lining appearance on a scale of 0–9. The reported data shows that at week 12, approximately 53.8% of participants in the higher-dose group (12 mg twice daily) met the definition of "clinical response" — meaning their symptom score dropped by a set amount — compared with 50.0% of those in the placebo group. The trial also tracked undesirable medical events (called adverse events, or AEs) that occurred during the study. In the double-blind phase, 21 out of 26 participants in the higher-dose group and 6 out of 8 in the placebo group experienced at least one such event. Serious adverse events — those considered more significant, such as requiring hospitalisation — were reported in 4 participants in the higher-dose group and 1 in the placebo group during the double-blind phase. Two participants in the higher-dose group stopped the study because of an adverse event during this phase, compared with none in the placebo group. The reported data also notes that certain pre-specified events of special interest — including skin reactions, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19 — were monitored and counted separately, with varying numbers reported across both groups. It is worth noting that this was a relatively small trial, and the 6 mg twice-daily group had only four participants, so the data for that group was not included in the primary outcome comparisons reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02914600 · results posted 10 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02914600) enrolled 1,188 participants across three groups: 945 received filgotinib 200 mg, 119 received filgotinib 100 mg, and 124 received a placebo (a dummy treatment with no active ingredient). The trial was measuring unintended medical events that occurred during treatment — known as treatment-emergent adverse events — as its main focus, alongside tracking changes in Crohn's disease symptom scores, including bowel frequency, abdominal pain, and an overall disease activity score (a combined measure of eight different symptoms rated on a scale of 0 to 600, where higher numbers mean worse symptoms). The reported data shows that, for the primary measure of unintended medical events during treatment, 820 out of 945 participants in the filgotinib 200 mg group, 103 out of 119 in the filgotinib 100 mg group, and 96 out of 124 in the placebo group experienced at least one such event. For the secondary symptom measures, the reported data shows that the filgotinib 200 mg group started with a higher overall disease activity score (around 280) compared to the 100 mg group (around 190) and the placebo group (around 120). Over the course of the trial, the reported change in that overall score reached approximately −110 points in the 200 mg group, −41 points in the 100 mg group, and nearly no change (around +1 point) in the placebo group. Similar patterns in the reported numbers were seen for the bowel frequency and abdominal pain sub-scores, with the 200 mg group showing the largest reported decreases from their starting values. It is worth noting that the three groups started at notably different baseline levels, which the data does not fully explain. The reported data also shows that zero participants were recorded as having "completed" the study in the milestone data, with all participants listed under "not completed," though the reason for this was not reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03599622 · results posted 3 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03599622) enrolled 239 people with Crohn's disease across four groups: a placebo group (60 people) and three groups receiving different doses of the study drug BMS-986165 — 3 mg (86 people), 6 mg (84 people), and 12 mg (9 people). The trial was measuring two main things at 12 weeks: how many participants reached "clinical remission" (a standard symptom score dropping below a threshold suggesting low disease activity) and how many showed an "endoscopic response" (a meaningful improvement seen on a bowel camera examination). A pre-treatment screening period came before the main treatment period, and relatively small numbers completed the full treatment phase across all groups. The reported data shows that for the first primary measure — the proportion of participants reaching clinical remission at 12 weeks — the figures were 28.3% in the placebo group, 32.6% in the 3 mg group, 21.4% in the 6 mg group, and 22.2% in the 12 mg group. For the second primary measure — the proportion showing an endoscopic response at 12 weeks — the reported figures were 8.3% for placebo, 23.3% for the 3 mg group, 16.7% for the 6 mg group, and 33.3% for the 12 mg group (noting this last figure is based on only 9 participants). For the secondary measures, the reported data shows clinical response rates of 40.0%, 47.7%, 38.1%, and 55.6% respectively across the four groups; patient-reported symptom remission rates of 25.0%, 32.6%, 20.2%, and 33.3%; and average changes in the bowel camera severity score of −1.5, −2.5, −3.7, and −5.6 points (where a negative number means the score went down from the starting point). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04996797 · results posted 27 June 2024

  According to the results reported on ClinicalTrials.gov, this trial tested a medicine called tulisokibart against a placebo (an inactive dummy treatment) in people with ulcerative colitis. Participants were divided into two groups, called Cohort 1 and Cohort 2, based on a biological marker test. In total, 178 people took part — 68 received tulisokibart and 67 received placebo in Cohort 1, and 22 received tulisokibart and 21 received placebo in Cohort 2. The trial measured several things, including how many participants reached "clinical remission" (a combination of low scores on bowel frequency, rectal bleeding, and an internal camera examination of the bowel), as well as how many participants experienced unwanted medical events during the study. The reported data shows that, for the primary goal of clinical remission in Cohort 1, 26.5% of participants who received tulisokibart and 1.5% of those who received placebo met the remission definition. For unwanted medical events (called adverse events) across both cohorts combined, 45.6% of tulisokibart participants and 43.2% of placebo participants experienced at least one such event. The reported data also shows that 1.1% of tulisokibart participants and 3.4% of placebo participants stopped the study because of an unwanted event. It is important to note that the trial records show zero participants were marked as having "completed" the study — the reasons for this were not explained in the data as reported. The reported secondary outcome data shows that in Cohort 1, 36.8% of tulisokibart participants and 6.0% of placebo participants showed improvement on the bowel camera examination, while 66.2% of tulisokibart participants and 22.4% of placebo participants showed what the trial defined as a "clinical response" (a meaningful reduction in their overall symptom score). Among participants across both cohorts who tested positive on a specific biological marker test, 31.6% of those on tulisokibart and 10.8% of those on placebo met the clinical remission definition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03283085 · results posted 21 June 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03283085) looked at a medicine called ontamalimab in people with two types of inflammatory bowel disease: ulcerative colitis (UC) and Crohn's disease (CD). A total of 557 people started the trial across six groups, receiving either a 25 mg dose, a 75 mg dose, or starting on 25 mg and then moving up to 75 mg. The trial's main focus was on monitoring participants for any medical events or changes in their health during treatment — including any unwanted medical occurrences, serious infections, blood test results, heart tracings (ECG), and measurements like blood pressure and temperature. The reported data shows that when it came to unwanted medical events that occurred during treatment, the numbers varied across groups. In the ulcerative colitis groups, 67 out of 89 participants (25 mg group), 122 out of 159 (25 mg then 75 mg group), and 203 out of 268 (75 mg group) experienced such events. In the Crohn's disease groups, the numbers were 4 out of 5, 8 out of 10, and 17 out of 26 respectively. For serious infections — meaning those that were life-threatening or needed hospital care or intravenous antibiotics — the reported data shows 5, 4, and 17 participants across the three UC groups, and zero participants in each of the three CD groups. For blood test changes, heart tracing changes, and vital sign changes, the reported data shows zero participants recorded with notable changes across all six groups. As a secondary measure, the number of UC participants recorded as having a treatment response (defined as a meaningful reduction in a combined score of bleeding and stool frequency) was reported as 116 in the 25 mg then 75 mg group and 129 in the 75 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03710486 · results posted 30 May 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 409 people in total — 185 in a group receiving vedolizumab (Cohort 1) and 224 in a group receiving an anti-TNF alpha therapy (Cohort 2), which is a different type of biologic medicine. The trial was an observational study, meaning researchers watched what happened in real-world clinical care rather than assigning experimental treatments. It was looking at how people with two types of inflammatory bowel disease — Crohn's disease (CD) and ulcerative colitis (UC) — had their biologic treatment managed over time, specifically whether their treatment dose needed to be increased or adjusted, and whether they stopped their treatment altogether. The reported data shows that among participants with Crohn's disease, 30.7% of those on vedolizumab and 42.1% of those on anti-TNF alpha therapy had at least one dose increase during the study. For those with ulcerative colitis, the reported figures were 43.5% for the vedolizumab group and 39.5% for the anti-TNF alpha group. Regarding stopping treatment altogether, the reported data shows that among Crohn's disease participants, 38.8% in the vedolizumab group and 49.3% in the anti-TNF alpha group discontinued their index therapy. For ulcerative colitis participants, 39.6% in the vedolizumab group and 50.0% in the anti-TNF alpha group were reported to have stopped treatment. The data also included counts of participants who had various reasons for treatment changes, though the specific category labels for those reasons were not included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02914561 · results posted 18 December 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT02914561) tested a medicine called filgotinib in people with Crohn's disease, a condition causing ongoing inflammation in the digestive tract. The trial ran in two parts: an induction phase (the first 10 weeks, where participants received either filgotinib at one of two doses — 200 mg or 100 mg — or a dummy pill called a placebo) and a maintenance phase (weeks 11 to 58, where those who had responded were reassigned to continue their dose or switch to placebo). In total, more than 1,370 people entered the induction phase across two groups (Cohort A and Cohort B, which reflected different prior treatment histories), and around 481 people entered the maintenance phase. The trial measured two main things: whether participants reached "clinical remission" (a scoring system based on symptoms like abdominal pain, stool frequency and general wellbeing dropped to a low level) and whether they showed "endoscopic response" (a camera examination of the bowel showed at least a 50% reduction in visible inflammation). The reported data shows the following numbers at the end of the 10-week induction phase. For clinical remission based on symptom scores, 32.9% of Cohort A participants on filgotinib 200 mg reached that threshold, compared with 25.7% on filgotinib 100 mg and 19.8% on placebo. In Cohort B, the figures were 26.7% (200 mg), 16.7% (100 mg), and 14.8% (placebo). For the bowel camera measure of response, 23.9% of Cohort A on filgotinib 200 mg met the threshold, versus 20.8% (100 mg) and 18.1% (placebo); in Cohort B the figures were 11.9%, 13.6%, and 11.4% respectively. Among secondary measures, the proportion showing a broader "clinical response" (a meaningful drop in symptom score) at week 10 ranged from 52.3% (Cohort A, 200 mg) down to 27.5% (Cohort B, placebo). The reported data from the maintenance phase (week 58) shows that among participants who continued on filgotinib 200 mg, 42.9% were in clinical remission and 30.4% showed endoscopic response, compared with 28.3% and 9.4% respectively among those who had been on filgotinib 200 mg but were switched to placebo. For the 100 mg dose, 23.5% of those who stayed on filgotinib were in clinical remission and 18.4% showed endoscopic response, versus 22.6% and 13.2% among those switched to placebo. No data was reported for the placebo-to-placebo maintenance group in these outcome measures based on the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03662542 · results posted 12 December 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03662542) enrolled 214 participants across three treatment groups to study two medicines — golimumab and guselkumab — used alone or together for a condition called ulcerative colitis, a type of inflammatory bowel disease. The trial ran in stages: a 12-week combination phase where all participants received both medicines, followed by a monotherapy phase (weeks 12–38) where each group continued with only one medicine or the combination, and then a safety follow-up period (weeks 38–50). The trial measured how participants' disease activity changed using a scoring tool called the Mayo score, which rates symptoms such as bowel frequency and bleeding on a scale from 0 to 12, with higher scores meaning more severe disease. The reported data shows that the primary thing measured was how many participants had a meaningful improvement in their Mayo score (called a "clinical response") by week 12. According to the results reported on ClinicalTrials.gov, 61.1% of participants in the golimumab-only group, 74.6% in the guselkumab-only group, and 83.1% in the combination group met this improvement threshold at week 12. A secondary measure looked at how many participants reached "clinical remission" — meaning their Mayo score dropped to 2 or below with no individual symptom score above 1. The reported data shows remission rates of 22.2% (golimumab only), 21.1% (guselkumab only), and 36.6% (combination group) at week 12. It is worth noting that the data as submitted covers only the combination phase outcomes in detail; additional secondary outcome measures beyond those two were not included in the structured data provided here, so further results, if any were collected, were not reported in this dataset. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02743806 · results posted 18 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT02743806) enrolled 331 participants, all of whom received vedolizumab 300 mg. The trial had a single treatment group and was primarily measuring the rates of adverse events (unexpected or unwanted medical occurrences during the study) and serious adverse events (those resulting in death, hospitalisation, lasting disability, or other significant medical consequences). Of the 331 people who started the trial, 150 completed it, while 181 did not complete it — the reasons for not completing were not detailed in the data provided here. The reported data shows that 61.9% of participants experienced at least one adverse event of any kind during the study, and 15.1% experienced at least one serious adverse event. The trial also tracked a separate category called "adverse events of special interest" — these were specific medical concerns the researchers were watching closely, including serious infections, certain types of cancer, liver injury, and reactions related to how the medication was given. The reported data shows that 3.9% of participants experienced one of these special-interest events. It is important to note that these figures describe events that were observed and recorded during the trial period — they do not on their own tell us whether vedolizumab caused these events, as adverse events can occur for many reasons unrelated to a study drug. No other outcome figures beyond these percentages were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05013905 · results posted 1 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT05013905) involved 55 people who received a treatment called PRA023, which was being studied in people with Crohn's disease — a condition that causes inflammation in the digestive tract. Of the 55 who started, 53 completed the study and 2 did not finish. The trial was measuring two main things: how the treatment affected participants' bodies (tracked through reported side effects and serious medical events), and whether it produced measurable improvements in their Crohn's disease, as assessed through a camera examination of the bowel (called an endoscopy) and a scoring system based on symptoms. The reported data shows that, out of 55 participants, 43 experienced what are called "treatment-emergent adverse events" — meaning unwanted health events that occurred during the study period. Of those, 8 experienced a "serious adverse event" (a more significant medical event, such as one requiring hospitalisation), and 2 participants stopped taking the treatment due to an adverse event. On the disease-activity side, the reported data shows that 13 out of 55 participants showed endoscopic improvement — meaning their bowel camera score improved by at least half compared to where they started. For secondary (additional) measures, 27 out of 55 participants were reported to have reached clinical remission (a symptom score falling below a set threshold indicating low disease activity), and 9 out of 55 met a combined measure of both bowel camera improvement and symptom score improvement at the same time. These figures describe what was observed and counted in this particular group of trial participants, under the specific conditions of this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03650413 · results posted 29 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03650413) involved 143 participants, all of whom received a treatment called UTTR1147A. The trial was designed to track unwanted or unexpected health events (known as "adverse events") that participants experienced while on the treatment. Of the 143 people who started the trial, 82 completed it, while 61 did not complete it — the reasons for not completing were not detailed in the data provided here. The reported data shows that the primary outcome measured was the number of participants who experienced adverse events, with their seriousness rated using a standard medical grading system. According to the results reported on ClinicalTrials.gov, two figures were recorded under this outcome: 9 participants and 52 participants. However, the data as submitted does not clearly label what each of these two numbers specifically refers to (for example, whether they represent different levels of seriousness of adverse events), so a precise breakdown cannot be described here without risk of misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04677179 · results posted 5 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04677179) tested an investigational drug called LY3471851 in people with ulcerative colitis, a condition causing inflammation in the large bowel. The trial ran across several phases — an induction period (initial treatment), a maintenance period, an extension period, and a follow-up period. In the first phase, 32 people received the high dose, 35 received the low dose, and 14 received a placebo (a dummy treatment with no active ingredient). Smaller numbers of participants continued into the later phases of the trial. The primary thing the trial was measuring was how many participants reached "clinical remission" at week 12 — meaning their bowel symptoms (stool frequency and bleeding) and a camera examination of the bowel had all returned to near-normal levels. The reported data shows that 17.2% of people in the high-dose group, 7.1% in the low-dose group, and 14.3% in the placebo group met this definition at week 12. For the secondary measures, the reported data shows that around 41% (high dose), 39% (low dose), and 36% (placebo) of participants showed a meaningful overall improvement in their disease score ("clinical response"). Regarding bowel camera findings specifically, 24% (high dose), 14% (low dose), and 29% (placebo) reached endoscopic remission, while 38% (high dose), 32% (low dose), and 21% (placebo) showed at least some improvement on camera ("endoscopic response"). For symptom-based measures, roughly 28% (high dose), 32% (low dose), and 21% (placebo) reached symptomatic remission, and around 45% (high dose), 43% (low dose), and 43% (placebo) showed a meaningful symptom improvement. It is worth noting that none of the trial periods recorded any participants formally completing those phases in the data as submitted — the reasons for this were not reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03298022 · results posted 6 July 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 adults with ulcerative colitis that had not responded to other treatments. All participants received a drug called ALTB-168 — 10 of them received 8 doses (the pilot phase) and 14 received 10 doses (the main phase). The trial was primarily measuring how many patients showed a meaningful improvement in their condition by week 12, using a standard scoring system called the Mayo Clinic Score, which tracks symptoms like bleeding and inflammation seen during a camera examination of the bowel. Eleven participants completed the study and 13 did not. The reported data shows that, for the primary outcome at week 12, 22.2% of patients in the 8-dose pilot group and 50% of patients in the 10-dose main group met the definition of "clinical response" — meaning their symptom score dropped by a required amount on the scoring scale. For secondary outcomes, the reported data shows that between 11.1% and 35.7% of patients (varying by group and time point) met the definition of "clinical remission," meaning their scores fell to a very low level. When looking at healing of the bowel lining as seen by camera, 2 participants in the 8-dose group and 4 in the 10-dose group showed this at week 12. Scores measuring bowel inflammation on the camera exam showed small average reductions from the starting point in both groups. For tissue samples assessed under a microscope (using a system called the Geboes grade), 0 participants in the 8-dose group and 2 in the 10-dose group met the target score at week 12, rising to 1 and 4 respectively at a later time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05013385 · results posted 26 June 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT05013385) enrolled 5 participants. The study was designed to look at responses to a treatment for stenosis — a narrowing of a passage in the body — by measuring both symptoms (how patients felt) and X-ray or imaging changes at two points in time: 24 weeks and 48 weeks into the study. The reported data shows that none of the 5 enrolled participants progressed into the main randomised, blinded treatment phase of the trial (where participants are assigned to a treatment group without knowing which treatment they receive). As a result, none of the participants completed the study, and all 5 are recorded as not having completed it. Because no participants entered the treatment phase, the reported data shows no results for any of the outcome measures — neither the primary outcomes (symptom response and imaging response at 48 weeks) nor the secondary outcomes (symptom response and imaging response at 24 weeks). The numbers for these measures were not reported, meaning no conclusions about the treatment's effects can be drawn from this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03635112 · results posted 13 March 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03635112) enrolled 159 adults with Crohn's disease across three groups: 38 people received a placebo (a dummy treatment with no active ingredient), 58 received a lower dose of the investigational drug TD-1473 (80 mg), and 63 received a higher dose (200 mg). The trial primarily measured changes in a scoring system called the Crohn's Disease Activity Index (CDAI) — a scale from 0 to 600 that combines symptoms such as abdominal pain, bowel movements, and general wellbeing, where a higher score means more severe disease. Scores below 150 are considered to indicate remission (no active disease). The reported data shows that all three groups had lower CDAI scores after 12 weeks compared to where they started. The placebo group's score dropped by an average of about 105 points, the 80 mg group's by about 106 points, and the 200 mg group's by about 118 points. For the secondary measures, 19 placebo participants, 28 in the 80 mg group, and 34 in the 200 mg group met the definition of "clinical response" (a drop of at least 100 points or a score below 150). Remission at 12 weeks (a CDAI score under 150) was reported in 13 placebo participants, 13 in the 80 mg group, and 22 in the 200 mg group. When bowel lining was examined by camera (endoscopy), a measurable improvement was seen in 6 placebo participants, 5 in the 80 mg group, and 15 in the 200 mg group. A combined measure of reduced stool frequency and abdominal pain showed remission in 6, 6, and 10 participants across the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03093259 · results posted 8 February 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03093259) looked at a drug called ABX464 in people with ulcerative colitis. A total of 32 participants took part — 23 received ABX464 and 9 received a placebo (a dummy treatment with no active ingredient). Of those, 21 in the ABX464 group and all 9 in the placebo group completed the study. The trial was primarily measuring how many participants in each group experienced adverse events (unwanted health events that happened during the study), and also tracked several measures of disease activity. The reported data shows that 18 out of 23 participants in the ABX464 group experienced a treatment-emergent adverse event (meaning an unwanted health event that occurred after starting treatment), compared with 5 out of 9 in the placebo group. For the secondary measures, the trial tracked clinical remission (a score indicating very low disease activity) at Week 8: 7 out of 23 in the ABX464 group and 1 out of 9 in the placebo group reached this point. The reported data also shows that 15 out of 23 ABX464 participants still had elevated levels of a gut inflammation marker called faecal calprotectin at Week 8, compared with 8 out of 9 in the placebo group. On a disease activity scoring tool called the Total Mayo Score (which runs from 0 to 12, where 12 is the worst), the ABX464 group's average score changed by −4.6 points from the start of the study, while the placebo group's changed by −2.1 points. A related shorter score (the Partial Mayo Score, running from 0 to 9) changed by −3.9 points in the ABX464 group and −1.8 points in the placebo group. It is worth noting that this was a small study with 32 participants in total, which limits how much can be read into any of these figures. These numbers describe what was recorded in this specific group of trial participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02039063 · results posted 30 January 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people in total across four groups, each receiving a different dose of a drug called E6011 (2 mg/kg, 5 mg/kg, 10 mg/kg, or 15 mg/kg). The trial was primarily set up to track and record any medical events or changes in participants' bodies that occurred during treatment — including unexpected health events, blood test results, blood pressure and pulse readings, heart trace (ECG) readings, chest X-rays, and neurological (brain and nerve) checks. The reported data shows that, when it came to unexpected medical events that arose during the treatment period (called treatment-emergent adverse events), all 6 participants in the lowest-dose group, all 6 in the 5 mg/kg group, all 7 in the 10 mg/kg group, and 3 out of 7 in the highest-dose group experienced at least one such event. Serious adverse events — meaning those involving hospitalisation, life-threatening situations, or major disruption to daily life — were reported in 1 participant in the 2 mg/kg group, 1 in the 5 mg/kg group, 5 in the 10 mg/kg group, and 0 in the 15 mg/kg group. For all other monitored measures — blood tests, vital signs, heart traces, chest X-rays, and neurological findings — the reported data shows that no participants in any group had a result that the investigators considered clinically significant (that is, meaningfully outside the normal range). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04577794 · results posted 27 January 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04577794) enrolled 31 people with ulcerative colitis — 21 received the investigational drug GLPG3970 and 10 received a placebo (a dummy treatment with no active ingredient). Most participants finished the trial: 20 in the GLPG3970 group and 9 in the placebo group. The main thing the trial was measuring was a change in something called the Mayo Clinical Score (MCS) — a scoring system used to gauge how active ulcerative colitis is, based on four things: how often a person goes to the toilet, rectal bleeding, what a camera inspection of the bowel shows, and a doctor's overall assessment. Scores range from 0 (no disease activity) to 12 (very severe). The reported data shows that, after 6 weeks, both groups had the same average reduction in their total MCS score: the GLPG3970 group's score dropped by an average of 2.6 points, and the placebo group's score also dropped by an average of 2.6 points. Regarding unwanted health events that occurred during the trial (called treatment-emergent adverse events), the reported data shows that 11 out of 21 participants in the GLPG3970 group and 3 out of 10 in the placebo group experienced at least one such event. No serious adverse events — meaning events that were life-threatening, required hospitalisation, or caused lasting harm — were recorded in either group. Additionally, 4 participants in the GLPG3970 group and 1 in the placebo group experienced adverse events that were considered possibly related to the study treatment. The trial also measured the level of GLPG3970 in participants' blood, with an average recorded level of 73.2 nanograms per millilitre (a standard unit for measuring tiny amounts of a substance in blood), though the full breakdown of those figures was only reported for the GLPG3970 group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02150551 · results posted 20 January 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled just one participant — a child or young adult with inflammatory bowel disease (IBD). The trial was testing an infusion treatment using a type of cell called mesenchymal stromal cells (MSCs), which are cells derived from donated bone marrow. The participant received weekly infusions over 8 weeks and was then monitored for up to 2 years afterwards. The main thing the trial was set up to measure was how often participants experienced serious or non-serious unwanted health events, or stopped treatment early. The reported data shows that 1 out of 1 participant experienced an adverse event (an unwanted health event) during the study. No further breakdown of what that event involved was provided in the submitted results. The trial also intended to measure whether participants showed a meaningful improvement in their IBD symptoms (using standard scoring tools) and whether certain blood and stool tests showed changes — however, the reported data shows that no results were submitted for either of those two secondary outcome measures, so those figures are not available. It is worth noting that with only one person taking part, this trial was extremely small — far too small to draw any broad conclusions. According to the results reported on ClinicalTrials.gov, this appears to have been an early-stage study, likely focused on feasibility and initial safety monitoring rather than proving anything definitive about the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03996369 · results posted 21 December 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03996369) enrolled 354 people with ulcerative colitis — 238 in the etrasimod 2 mg group and 116 in the placebo group. The trial was measuring several things related to disease activity, including whether participants reached "clinical remission" (a combination of normal or near-normal stool frequency, no rectal bleeding, and improved results on a camera examination of the bowel), as well as other markers such as symptom relief, bowel-lining appearance, and overall clinical response. The reported data shows that for the main measure — the percentage of participants reaching clinical remission — 24.8% of those taking etrasimod and 15.2% of those taking placebo met that standard by the end of the study. For the additional measures, the reported data shows: 62.2% of the etrasimod group and 41.1% of the placebo group achieved a meaningful improvement in their overall disease score (called "clinical response"); 46.8% versus 29.5% reached symptomatic remission (normal or near-normal stool frequency and no rectal bleeding); 30.6% versus 18.8% showed improvement on the camera examination of the bowel lining; 16.2% versus 8.9% showed combined improvement on both the camera examination and a tissue sample (mucosal healing); and 17.1% versus 8.0% had a completely normal result on the camera examination. It is worth noting that 213 of the 238 participants in the etrasimod group and 103 of the 116 in the placebo group completed the study, meaning a small number in each group did not finish — the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03945188 · results posted 20 December 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03945188) enrolled 433 people with ulcerative colitis — 289 received a daily 2 mg dose of a medicine called etrasimod, and 144 received a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was mainly measuring how many participants reached "clinical remission" — meaning their bowel symptoms and results from a camera examination of the bowel (endoscopy) had improved to near-normal levels — at two points in time: 12 weeks and 52 weeks. The reported data shows that at 12 weeks, 27.0% of people in the etrasimod group met the criteria for clinical remission, compared with 7.4% in the placebo group. At 52 weeks, those figures were 32.1% for etrasimod and 6.7% for placebo. For the secondary measures — things like improvement seen on the camera examination alone, and relief from bowel symptoms such as bleeding and stool frequency — the reported numbers followed a similar pattern. At 12 weeks, 35.0% of the etrasimod group showed endoscopic (camera) improvement versus 14.1% in the placebo group; at 52 weeks those figures were 37.2% and 10.4% respectively. For symptom relief alone, 46.0% (etrasimod) versus 21.5% (placebo) met the criteria at 12 weeks, and 43.4% versus 18.5% at 52 weeks. It is also worth noting that by the end of the study, 128 people in the etrasimod group and 98 in the placebo group did not complete the trial; the reasons were not detailed in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04102111 · results posted 9 December 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04102111) looked at an investigational medicine called JNJ-67864238 in people with Crohn's disease, a condition that causes ongoing inflammation in the digestive tract. A total of 48 people took part — 18 received a placebo (a dummy treatment with no active ingredient) and 30 received JNJ-67864238. The trial ran for 12 weeks and measured things like disease activity scores, bowel symptoms, and what the gut lining looked like on camera (endoscopy). Of those who started, 14 in the placebo group and 23 in the JNJ-67864238 group completed the study. The reported data shows that on the main measure — a disease activity scoring tool called the CDAI (scored 0–600, where higher means more severe disease) — the placebo group's average score fell by about 153 points from the start, while the JNJ-67864238 group's average score fell by about 125 points. For the endoscopy score (SES-CD, scored 0–56), the placebo group's average score dropped by 0.4 points and the JNJ-67864238 group's dropped by 1.6 points. Looking at individual responses, 61% of placebo participants and 47% of JNJ-67864238 participants met the threshold for a meaningful reduction in their disease activity score. Clinical remission (a CDAI score below 150) was recorded in 44% of the placebo group and 40% of the JNJ-67864238 group. On the gut-lining camera score, 5.6% of placebo participants and 26.7% of JNJ-67864238 participants showed at least a 50% improvement. For a measure combining stomach pain and stool frequency, both groups had the same result — 33.3% of participants in each group met the remission threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03524092 · results posted 25 November 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03524092) tested a medicine called mirikizumab in people with ulcerative colitis, a condition causing inflammation in the large bowel. The main part of the trial focused on participants who had already responded to mirikizumab during an earlier induction (starting) phase. These participants were then randomly assigned to continue receiving mirikizumab injections under the skin (200 mg) or to switch to a placebo (an inactive dummy injection) for a 40-week maintenance period. A total of 192 participants were assigned to the placebo group and 389 to the mirikizumab group in this blinded phase. The trial was primarily measuring how many participants reached "clinical remission" at week 40 — meaning their symptoms (bleeding and stool frequency) and bowel appearance on camera had improved to near-normal levels by a set scoring standard. The reported data shows that, for the primary outcome of clinical remission at week 40, approximately 49.9% of participants receiving mirikizumab met the criteria, compared with 25.1% in the placebo group. For the secondary outcomes, the reported figures were: endoscopic remission (improvement seen on camera) — 58.6% (mirikizumab) versus 29.1% (placebo); remission based on tissue samples taken during the camera examination — 48.5% versus 24.6%; symptom remission (bleeding and stool frequency only) — 71.0% versus 39.7%; endoscopic response (at least some improvement on camera) — 72.6% versus 40.8%; and overall clinical response — 80.3% versus 49.2%. All of these figures reflect the proportions of participants in each group who met each specific measurement at week 40 as defined by the trial's scoring rules. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03345849 · results posted 23 November 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03345849) looked at a medicine called upadacitinib (45 mg daily) compared to a placebo (an inactive treatment) in people with Crohn's disease. The first part of the trial ran for 12 weeks and included 176 people in the placebo group and 350 people in the upadacitinib group. A smaller second part ran from weeks 12 to 24, involving 57 and 59 participants respectively, though the results below focus on the 12-week findings. The trial measured three main things: whether participants reached a level of symptom control called "clinical remission" (assessed two different ways), and whether internal inflammation visible on a camera examination of the bowel had reduced by more than half (called "endoscopic response"). The reported data shows the following at the 12-week mark. For clinical remission measured by a symptom scoring tool called CDAI, 49.5% of people in the upadacitinib group reached that threshold, compared with 29.1% in the placebo group. When remission was measured using patients' own daily diary records of stool frequency and abdominal pain, 50.7% of the upadacitinib group met the target, versus 22.2% in the placebo group. For the bowel camera measurement, 45.5% in the upadacitinib group showed a meaningful reduction in visible inflammation, compared with 13.1% in the placebo group. On a secondary measure — a deeper level of bowel-camera improvement called "endoscopic remission" — 28.9% of the upadacitinib group met that threshold versus 7.4% in the placebo group. Among participants who were taking steroid medicines at the start, 42.9% in the upadacitinib group had stopped steroids and reached clinical remission by week 12, compared with 15.7% in the placebo group. Finally, on a 0–52 fatigue questionnaire (where higher scores mean less fatigue), the upadacitinib group's scores improved by an average of 11.3 points from their starting point, while the placebo group improved by 5.0 points on average. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02394028 · results posted 16 November 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02394028) tested a medicine called etrolizumab in people with Crohn's disease. The trial was run in two main stages — an induction phase (the first 14 weeks) and a maintenance phase (continuing out to around week 66). During the induction phase, participants were divided into several groups across three cohorts, receiving either etrolizumab (at a dose of 105 mg or 210 mg) or a placebo (a dummy treatment with no active ingredient). In total, across all induction cohorts, 1,035 people started the induction phase. Of those who responded to treatment during induction, 487 people then entered the maintenance phase. The trial measured two main things: whether participants reached "clinical remission" (a significant reduction in symptoms such as loose stools and abdominal pain) and whether there was "endoscopic improvement" (a 50% or greater reduction in visible gut inflammation seen via camera). The reported data shows the following for the induction phase at week 14. In the exploratory Cohort 1, clinical remission was reported in 11.9% of placebo participants, 20.0% of those on etrolizumab 105 mg, and 27.3% on etrolizumab 210 mg. Endoscopic improvement in Cohort 1 was reported in 3.4% (placebo), 19.5% (105 mg), and 16.8% (210 mg). In the larger, pivotal Cohort 3, clinical remission was reported in 29.2% of placebo participants, 30.1% on etrolizumab 105 mg, and 33.1% on etrolizumab 210 mg. Endoscopic improvement in Cohort 3 was reported in 21.6% (placebo), 26.2% (105 mg), and 27.4% (210 mg). An open-label Cohort 2 (where all participants knew they were receiving etrolizumab, with no placebo group) reported clinical remission in 29.5% on 105 mg and 29.3% on 210 mg, and endoscopic improvement in 20.8% and 22.2% respectively. For the maintenance phase at week 66, the reported data shows results for two groups: participants who had responded to etrolizumab during induction and were then switched to placebo, and those who continued on etrolizumab 105 mg. Clinical remission at week 66 was reported in 24.0% of those switched to placebo and 35.0% of those who continued on etrolizumab. Endoscopic improvement at week 66 was reported in 12.2% of the placebo group and 23.6% of those continuing on etrolizumab. Results for the small group of placebo-only responders who continued on placebo through maintenance were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03758443 · results posted 15 November 2022

  According to the results reported on ClinicalTrials.gov, this trial tested three doses of an investigational medicine called TD-1473 (20 mg, 80 mg, and 200 mg) against a placebo (an inactive treatment) in people with ulcerative colitis. A total of 239 people started the initial treatment phase, spread across the four groups. The trial was measuring changes in disease severity using standardised scoring tools that look at things like how often participants needed to go to the toilet, rectal bleeding, and what the bowel lining looked like on camera (endoscopy). The trial ran in stages: an initial induction period, an extended induction period, and a longer maintenance period. The reported data shows that for the main (primary) measure in the first eight weeks — a disease severity score out of 12, where higher means worse — all groups showed a reduction from their starting score. The placebo group's average score dropped by 1.75 points, while the TD-1473 groups dropped by 2.02 points (20 mg), 2.12 points (80 mg), and 2.40 points (200 mg). For the second primary measure — how many people in the maintenance phase met the criteria for being in "remission" (meaning their symptoms and bowel appearance had settled to a low level) at around week 44 — the numbers were small across all groups: 4 people in the placebo group, 3 in the 20 mg group, 5 in the 80 mg group, and 3 in the 200 mg group. The reported data also shows that at week 8, only small numbers across all groups met the remission criteria (6, 6, 4, and 4 participants respectively). Secondary measures looking at clinical response, endoscopic remission, and symptom remission at week 44 similarly showed small numbers across all groups, with no group standing out markedly from the others. It is worth noting that by the maintenance phase, the number of participants in each group had reduced considerably from the starting numbers, which the reported data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03920254 · results posted 2 November 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03920254) tested three different doses of a drug called TD-1473 — 20 mg, 80 mg, and 200 mg. A total of 46 people took part across the three dose groups: 13 received the 20 mg dose, 18 received the 80 mg dose, and 15 received the 200 mg dose. The trial recorded that none of the participants completed the study, though the reasons for this are not detailed in the reported data. The reported data shows that the main thing being measured was how many people in each group experienced what are called "treatment-emergent adverse events" (TEAEs) — that is, any unwanted health events that occurred from the time of the first dose up to four weeks after the last dose, including any notable changes in blood tests, heart readings, or vital signs. According to the results reported on ClinicalTrials.gov, in the 20 mg group, 4 out of 13 participants experienced a TEAE; in the 80 mg group, 5 out of 18 participants experienced a TEAE; and in the 200 mg group, 6 out of 15 participants experienced a TEAE. No secondary outcome measure data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04130919 · results posted 24 August 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04130919) looked at a medicine called tilpisertib in people with ulcerative colitis, a condition causing inflammation in the large bowel. The trial had two stages: a blinded phase (where participants didn't know which treatment they were getting) and an open-label phase (where everyone received tilpisertib). In the blinded phase, 7 people received tilpisertib 300 mg, 6 received tilpisertib 100 mg, and 6 received a placebo (a dummy treatment with no active ingredient). Of those, 5, 4, and 3 people respectively completed that phase. A smaller group then continued into the open-label phase, with 10 participants in total starting it, though only 2 finished it. The trial was measuring things like whether participants reached "remission" (very low disease activity) and whether their bowel lining showed improvement on camera (endoscopy) at 10 weeks. The reported data shows that for the main goal — clinical remission at Week 10, measured using a scoring system that combines bowel camera findings, bleeding, stool frequency, and the doctor's overall assessment — 0% of participants in all three blinded-phase groups (tilpisertib 300 mg, tilpisertib 100 mg, and placebo) met that standard. Similarly, 0% in all three groups reached the stricter "MCS remission" measure. For endoscopic response (improvement seen on the bowel camera), the reported figures were 14.3% in the tilpisertib 300 mg group, 16.7% in the tilpisertib 100 mg group, and 0% in the placebo group. For a broader measure of overall disease response (MCS response), figures were 28.6%, 16.7%, and 16.7% respectively. When looking at tissue samples under a microscope (histologic remission), the reported rates were 16.7%, 16.7%, and 25.0% across the three groups. The trial also tracked unwanted events (adverse events) experienced during treatment; in the blinded phase, 57.1% of the tilpisertib 300 mg group, 50.0% of the tilpisertib 100 mg group, and 50.0% of the placebo group reported at least one such event. It is worth noting that this was a very small trial — fewer than 20 people in the blinded phase — so these percentages are based on very small numbers of individuals. The reported data shows no statistical analysis was included in the submitted results, so no conclusions about differences between groups can be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03345836 · results posted 15 August 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03345836) enrolled people with Crohn's disease and ran in multiple parts. In the first 12-week phase, 171 participants received a placebo (an inactive treatment) and 324 received upadacitinib 45 mg in a double-blind setting (meaning neither the participants nor the doctors knew who got which), while a separate group of 129 received upadacitinib 45 mg in an open-label setting (where both parties knew what was being given). A smaller extended treatment phase then followed for a subset of participants. The trial measured things like disease activity scores, gut inflammation seen on camera (endoscopy), and how participants felt day-to-day, as well as tracking any unwanted medical events that occurred. The reported data shows that, at 12 weeks in the double-blind phase, 38.9% of participants taking upadacitinib 45 mg met the threshold for disease remission based on a standard scoring tool (a score below 150 on a scale that goes up to about 600), compared with 21.1% in the placebo group. For the endoscopy measure — looking at whether gut inflammation had reduced by more than half — 34.6% of the upadacitinib group met that marker, compared with 3.5% in the placebo group. On a separate measure based on participants' own daily diary reports of stool frequency and abdominal pain, 39.8% of the upadacitinib group met the remission threshold versus 14.0% in the placebo group. Deeper remission on endoscopy was reported in 19.1% versus 2.3%, and among those already using corticosteroids at the start, 34.3% of the upadacitinib group stopped steroids and reached remission compared with 11.7% in the placebo group. The reported data also shows that unwanted medical events (called adverse events — any health issue that arose during the trial, not necessarily caused by the treatment) were recorded in 112 of 171 placebo participants and 221 of 324 upadacitinib participants in the double-blind phase, with further events recorded across the other groups in later phases. The trial did not report a breakdown of what types of adverse events occurred within this summary data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03105128 · results posted 6 July 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03105128) looked at a medicine called risankizumab in people with Crohn's disease, a condition causing ongoing inflammation in the digestive tract. The trial ran in two periods. In the first period, 931 people took part — 373 received risankizumab at a 600mg dose, 372 received it at a 1200mg dose, and 186 received a placebo (a dummy treatment with no active medicine). A smaller second period then followed with 278 participants testing different doses. The trial measured two main things: how many participants reached "clinical remission" (meaning their symptoms such as stomach pain and bowel frequency fell below a defined threshold) and how many showed an "endoscopic response" (meaning a camera examination of the bowel showed at least a 50% reduction in visible signs of inflammation compared to the start). The reported data shows the following results from the first period. For clinical remission measured by a symptom scoring tool called CDAI (used specifically in the US), 24.6% of placebo participants, 45.2% of the 600mg group, and 41.6% of the 1200mg group reached that threshold. Using a different symptom measure (stool frequency and abdominal pain scores, used globally including outside the US), the reported figures were 21.7% for placebo, 43.5% for the 600mg group, and 41.0% for the 1200mg group. For endoscopic response — the bowel camera measure — 12.0% of placebo participants, 40.3% of the 600mg group, and 32.1% of the 1200mg group met that threshold. A secondary measure called CDAI clinical response (a meaningful drop in symptom score rather than full remission) was reported at 25.2% for placebo, 40.8% for the 600mg group, and 37.2% for the 1200mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03934216 · results posted 6 July 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03934216) enrolled 131 people in total — 88 in the treatment group and 43 in the placebo group. The trial was measuring outcomes in people with ulcerative colitis, a condition causing inflammation in the large bowel. The main thing the trial set out to measure was whether participants reached "clinical remission" by week 12 — meaning their bowel movement frequency, rectal bleeding, and bowel lining appearance (assessed by camera) had all improved to near-normal levels on a scoring system. A number of secondary measures were also tracked, including overall clinical response, bowel lining appearance on camera (endoscopic response), and microscopic tissue improvement (histological improvement, meaning changes seen when bowel tissue is examined under a microscope). The reported data shows that at week 12, the clinical remission rate was 14.8% in the treatment group and 16.3% in the placebo group — meaning roughly 15 in every 100 people in the treatment group, and about 16 in every 100 in the placebo group, met the remission criteria. For the secondary measures, a clinical response (a meaningful reduction in symptom scores) was reported in 37.5% of the treatment group and 32.6% of the placebo group. Endoscopic response (improvement seen on camera) was reported in 19.3% of the treatment group and 27.9% of the placebo group. Histological improvement (better results under the microscope) was reported in 21.6% of the treatment group and 16.3% of the placebo group. It is also worth noting that a large proportion of participants did not complete the study — 58 of 88 in the treatment group and 31 of 43 in the placebo group; the reasons for this were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02819635 · results posted 30 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02819635) looked at a medicine called upadacitinib in people with ulcerative colitis, a condition that causes inflammation in the large bowel. The trial was divided into three sub-studies. The first two sub-studies ran for 8 weeks and tested different doses of upadacitinib (7.5 mg, 15 mg, 30 mg, and 45 mg daily) compared to a dummy treatment (placebo). The third sub-study ran for 52 weeks and continued testing two of those doses (15 mg and 30 mg) against a placebo. In total, hundreds of participants took part across the three sub-studies — for example, Sub-study 1 enrolled 382 people, Sub-study 2 enrolled 474 people across both parts, and Sub-study 3 enrolled 1,046 people. The main thing being measured in all three sub-studies was the proportion of participants who reached "clinical remission" — a term meaning their bowel symptom scores (stool frequency, rectal bleeding, and appearance of the bowel lining on camera) had each fallen to a low or normal level. The reported data shows the following for the primary outcome of clinical remission. In Sub-study 1 at 8 weeks, 0% of placebo participants reached remission, compared with 8.5% on the 7.5 mg dose, 14.3% on the 15 mg dose, 13.5% on the 30 mg dose, and 21.4% on the 45 mg dose. In Sub-study 2 at 8 weeks, 4.8% of placebo participants reached remission compared with 26.1% on the 45 mg dose. In Sub-study 3 at 52 weeks, 12.1% of placebo participants reached remission, compared with 42.3% on the 15 mg dose and 51.7% on the 30 mg dose. For the secondary outcomes reported in Sub-study 1, the data shows that 2.2% of placebo participants had improvement in their bowel-lining appearance on camera at 8 weeks, compared with between 14.9% and 35.7% across the upadacitinib dose groups. For the measure of "clinical response" (a meaningful improvement in scores, even if not full remission), 13.0% of placebo participants met that bar, compared with between 29.8% and 55.4% across the upadacitinib dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03104413 · results posted 14 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03104413) tested the drug risankizumab in people with Crohn's disease, a condition that causes ongoing inflammation in the digestive tract. In the first part of the trial (Induction Period 1), 207 people received a dummy treatment (placebo), 206 received a 600 mg dose of risankizumab, and 205 received a 1,200 mg dose. A smaller second period tested additional doses in a further 211 participants. The trial measured things like whether participants' symptoms reached a level considered "remission" (meaning symptoms fell below a certain threshold on standard scoring tools), and whether there were signs of reduced inflammation when the bowel was examined with a camera (endoscopy). The reported data shows the following figures for the first induction period. For the main goal of reaching clinical remission using a widely used symptom scoring tool (called CDAI, which combines diary entries, physical checks and a blood test — lower scores mean fewer symptoms), 19.8% of placebo participants, 42.0% of those on the 600 mg dose, and 40.3% of those on the 1,200 mg dose were reported to have reached that threshold. For the camera-based measure of bowel inflammation improving by more than half, the reported figures were 11.2% (placebo), 28.8% (600 mg), and 34.2% (1,200 mg). For a separate symptom-based remission measure (tracking daily toilet visits and stomach pain scores), the same figures of 11.2%, 28.8%, and 34.2% were reported across the three groups respectively. On secondary measures — including a different symptom-score response target and a lower symptom-score remission check — the reported percentages ranged from roughly 19–21% for placebo up to approximately 33–61% for the risankizumab groups, depending on the specific measure. No outcome figures for Induction Period 2 were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03627091 · results posted 31 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03627091) enrolled 40 people with Crohn's disease across three groups: 19 received a placebo (a dummy treatment with no active ingredient), 10 received a lower dose of ontamalimab (25 mg), and 11 received a higher dose (75 mg). The trial ran for 52 weeks and was measuring whether participants reached certain pre-defined milestones related to their symptoms and gut inflammation — specifically, whether their abdominal pain and loose stool frequency fell below set thresholds, and whether internal examination of the bowel showed a meaningful improvement compared to the start of an earlier linked study. It is worth noting that a relatively large number of participants did not complete the study: 12 of 19 in the placebo group, 6 of 10 in the 25 mg group, and 5 of 11 in the 75 mg group. The reported data shows the following for the two primary (main) measures at Week 52. For symptom-based remission (low pain scores and reduced loose stools): 2 out of 19 placebo participants, 3 out of 10 in the 25 mg group, and 5 out of 11 in the 75 mg group met this threshold. For bowel-camera response (at least a 50% reduction in an inflammation score): 2 out of 19 placebo participants, 4 out of 10 in the 25 mg group, and 6 out of 11 in the 75 mg group met this threshold. Participants who dropped out or had missing data were counted as not meeting these thresholds. The reported data for the secondary (additional) measures also covers Week 52. Using a different symptom scoring tool called CDAI (a broader disease activity score), remission was recorded in 8 of 19 placebo participants, 4 of 10 in the 25 mg group, and 7 of 11 in the 75 mg group. For remission without the use of steroid medicines for at least 12 weeks beforehand, the numbers were 2, 1, and 3 respectively. Using yet another symptom diary scoring method, remission was seen in 2, 3, and 7 participants across the three groups. Finally, sustained remission — meaning participants met the symptom threshold both at the start of this maintenance study and at Week 52 — was recorded in 2, 1, and 2 participants respectively across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03518086 · results posted 28 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03518086) tested a medicine called mirikizumab (given by drip into a vein every four weeks) against a placebo (an inactive treatment given the same way) in people with ulcerative colitis, a condition causing inflammation in the large bowel. In total, 1,447 people were enrolled across all groups, with the main comparison involving 322 people in the placebo group and 959 people in the mirikizumab group (plus two smaller sub-groups of 41 and 125 people). The trial's main goal was to measure how many participants reached "clinical remission" — meaning their bowel movement frequency, rectal bleeding, and bowel lining appearance had all improved to near-normal levels — after 12 weeks of treatment. The reported data shows that for the main outcome at 12 weeks, 13.3% of placebo participants and 24.2% of mirikizumab participants were reported to have reached clinical remission. For the secondary outcomes, also at 12 weeks: a meaningful improvement in overall disease scores ("clinical response") was reported in 42.2% of the placebo group and 63.5% of the mirikizumab group; improvement in bowel lining appearance on camera ("endoscopic remission") was reported in 21.1% versus 36.3%; relief from bleeding and stool frequency symptoms ("symptomatic remission") in 27.9% versus 45.5%; a meaningful reduction in those same symptoms ("symptomatic response") in 52.4% versus 72.0%; and improvement seen in bowel tissue samples under a microscope ("histologic remission") in 15.6% versus 29.3%. It is worth noting that in every outcome measured, some participants in the placebo group also reached the relevant milestone, which is a common finding in clinical trials. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02891226 · results posted 28 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02891226) tested a medicine called mirikizumab in people with Crohn's disease, a condition causing inflammation in the digestive tract. The trial ran in multiple stages over several years. In the first stage (the first 12 weeks), 191 participants were divided into four groups: 64 received a placebo (a dummy treatment with no active medicine) given by drip into a vein every four weeks, and the rest received one of three different doses of mirikizumab — 31 people received 200 mg, 32 received 600 mg, and 64 received 1,000 mg — also by drip every four weeks. Participants then moved through further stages depending on how they responded, with later stages involving different doses or a under-the-skin injection form of the medicine. The trial was primarily measuring whether a camera examination of the bowel (an endoscopy) showed at least a 50% improvement in signs of disease after 12 weeks. The reported data shows that for the main outcome — the proportion of participants showing that 50% or greater improvement on their bowel camera score at week 12 — the figures were: 10.9% in the placebo group, 25.8% in the 200 mg mirikizumab group, 37.5% in the 600 mg group, and 43.8% in the 1,000 mg group. For a secondary outcome measuring a deeper level of improvement (bowel camera score falling into a very low range, called "remission"), the reported figures at week 12 were 1.6% for placebo, 6.5% for 200 mg, 15.6% for 600 mg, and 20.3% for 1,000 mg. Another secondary outcome looked at symptom remission based on patients' own reports of their stool frequency and abdominal pain — the reported proportions reaching that target at week 12 were 6.3% (placebo), 12.9% (200 mg), 28.1% (600 mg), and 21.9% (1,000 mg). Participants also rated the overall severity of their symptoms on a 6-point scale; the reported average change from the starting score at week 12 was −0.44 for placebo, −1.08 for 200 mg, −1.27 for 600 mg, and −0.98 for 1,000 mg, where a negative number means the average rating moved toward less severe symptoms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03290781 · results posted 14 January 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03290781) enrolled 366 people across seven groups to study a medicine called ontamalimab (ONTA) in people with ulcerative colitis — a condition causing inflammation in the large bowel. Participants were assigned to receive either a lower dose (25 mg) or higher dose (75 mg) of ONTA, or a placebo (a dummy treatment with no active ingredient), across two back-to-back periods of the study. The trial measured whether participants reached "remission" — meaning their symptoms and bowel-lining appearance had improved to near-normal levels — by week 52. Not all participants who started the study completed it; completion numbers varied considerably across the groups. The reported data shows the following number of participants who met the main goal of remission at week 52, based on a combined score of symptoms and a camera examination of the bowel: 6 out of 73 people who received the 25 mg dose followed by placebo; 38 out of 71 who received 25 mg in both periods; 11 out of 86 who received the 75 mg dose followed by placebo; and 33 out of 82 who received 75 mg in both periods. For the secondary (additional) measures — which looked at things like bowel lining appearance alone, symptom scores alone, sustained remission, overall response, and a combined measure of bowel lining and tissue health — the reported numbers followed a similar pattern, with consistently higher counts in the groups that continued receiving ONTA into the second period compared with those who switched to placebo. For example, for the combined bowel lining and tissue health measure, 37 participants in the 25 mg/25 mg group and 29 in the 75 mg/75 mg group met the threshold, compared with 6 and 11 respectively in the groups that switched to placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03464136 · results posted 11 January 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03464136) compared two medicines — adalimumab and ustekinumab — in people with Crohn's disease, a condition that causes ongoing inflammation in the digestive tract. A total of 195 people were assigned to the adalimumab group and 191 to the ustekinumab group, making 386 participants in all. The trial ran for 52 weeks and measured things like symptom scores, bowel inflammation seen on camera (endoscopy), and whether participants were able to stop taking steroid medicines. The reported data shows that at the 52-week mark, 61.0% of participants in the adalimumab group and 64.9% in the ustekinumab group met the trial's definition of "clinical remission" (a standard symptom score dropping below a set threshold). For a related measure — remission while also being off steroids for at least 30 days — the figures were 57.4% and 60.7% respectively. When looking at whether symptoms had reduced meaningfully from the start of the trial (called "clinical response"), 66.2% of the adalimumab group and 72.3% of the ustekinumab group met that marker. Self-reported symptom remission (covering stool frequency and abdominal pain) was recorded for 55.4% and 56.5% of participants in each group. At the earlier 16-week check, remission rates were 60.0% (adalimumab) and 57.1% (ustekinumab). For endoscopic remission — inflammation levels seen directly by camera — the reported figures were 30.7% and 28.5% in each group respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01150890 · results posted 3 January 2022

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called brodalumab in people with Crohn's disease, a condition causing ongoing inflammation in the digestive tract. A total of 130 people took part, split into four groups: 32 received a placebo (a dummy treatment with no active medicine), 32 received brodalumab at 210 mg, 33 at 350 mg, and 33 at 700 mg. The main thing the trial was measuring was how many people in each group reached what is called "clinical remission" — meaning their disease activity score (measured using a tool called the CDAI, which rates symptoms like abdominal pain, bowel habits and general wellbeing on a scale of 0 to 600) dropped to 150 points or below by week 6. The reported data shows that for the primary goal of reaching remission at week 6, the percentages were: 3.1% in the placebo group, 3.1% in the 210 mg brodalumab group, 15.2% in the 350 mg group, and 9.1% in the 700 mg group. For one of the secondary measures — whether participants' CDAI score fell by at least 100 points from their starting level — the reported figures were 12.5% (placebo), 16.1% (210 mg), 27.3% (350 mg), and 15.2% (700 mg). When looking at the average change in CDAI score from the start of the trial to week 6, all groups showed some decrease (a negative number meaning lower disease activity scores), with the placebo group changing by −28.2 points, the 210 mg group by −8.7 points, the 350 mg group by −35.4 points, and the 700 mg group by −0.6 points. The reported data also shows that the number of participants who experienced at least one adverse event (an unwanted medical occurrence during the trial) was 25 in the placebo group, 23 in the 210 mg group, 27 in the 350 mg group, and 28 in the 700 mg group, though no deaths were recorded in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03269695 · results posted 28 December 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03269695) enrolled 20 people in total — 10 in each group. One group received a placebo plus infliximab (an existing medicine), and the other received an investigational drug called PF-06687234 (20 mg) plus infliximab. The trial was measuring whether participants reached a state called "modified clinical remission" at 12 weeks — a standard scoring system used in bowel disease research that looks at factors like bowel habits, bleeding, and internal examination findings, with lower scores indicating less disease activity. Eight people in the placebo group and seven in the PF-06687234 group completed the study. The reported data shows that for the main (primary) outcome — the percentage of participants reaching modified clinical remission at Week 12 — the numbers were small. Using one method of handling missing data (called the "observed cases" approach, meaning only people with available data were counted), 12.5% of the placebo group and 14.3% of the PF-06687234 group met the remission criteria under one scoring definition. Under a stricter scoring definition using the same approach, 0% of the placebo group and 14.3% of the PF-06687234 group met the criteria. Using a different method of handling missing data (called the "treatment failure" approach, where anyone with missing data is counted as not having responded), both groups showed 10% remission under the first definition, and 0% versus 10% under the stricter definition. For a secondary outcome, the reported data shows that the percentage of participants whose internal examination scores improved at Week 12 was 25.0% (placebo group) versus 57.1% (PF-06687234 group) using the observed cases approach, and 20.0% versus 40.0% using the treatment failure approach. It is important to note that this was a very small trial of only 10 people per group, and the numbers reported here reflect that small size. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02976129 · results posted 22 December 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02976129) looked at a treatment called V565 for people with Crohn's disease, a condition that causes ongoing inflammation in the digestive tract. A total of 125 people took part — 82 received V565 and 43 received a placebo (a dummy treatment with no active ingredient). The trial's main goal was to measure how many people in each group showed a meaningful response by Day 42 (six weeks into the study). A "response" was defined as a notable improvement in Crohn's disease symptom scores — measured using a tool called the CDAI (Crohn's Disease Activity Index, a scale from 0 to 600 where lower scores mean fewer symptoms) — along with a reduction in two blood or stool markers of inflammation called CRP and FCP. The reported data shows that for the primary measure, 29 out of 82 participants (roughly 35%) in the V565 group met the response criteria at Day 42, compared with 16 out of 43 participants (roughly 37%) in the placebo group. For the secondary measure — which used a stricter definition of response requiring a larger drop in both the symptom score and the inflammation markers — 20 out of 82 V565 participants and 9 out of 43 placebo participants met that threshold. The reported data also shows that in a smaller sub-group who had a camera examination of the gut lining, 18 V565 participants showed an improvement in appearance compared with 3 placebo participants. For the additional inflammation marker measures, 11 V565 participants versus 4 placebo participants reached normal CRP levels at both check-in points, and 7 versus 3 participants reached normal FCP levels. It is worth noting that the placebo group was smaller than the V565 group, so direct number-to-number comparisons need to be interpreted carefully — the proportions in each group matter as much as the raw counts. The reported data does not include further statistical analysis figures in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03653026 · results posted 26 November 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03653026) looked at a medicine called upadacitinib in people with ulcerative colitis, a condition causing inflammation in the large bowel. The trial ran in two parts. In the first part, 345 people were assigned to receive upadacitinib 45 mg and 177 received a dummy treatment (placebo) for 8 weeks. After that first part, some participants continued into a second open-label phase where everyone received upadacitinib — 68 people who had already been on upadacitinib continued on it, and 116 who had been on placebo switched to upadacitinib. The trial measured things like bowel symptoms, rectal bleeding, and what the bowel lining looked like on camera (endoscopy), using a scoring system called the Adapted Mayo Score. The reported data shows that, at 8 weeks, 33.5% of people in the upadacitinib group met the definition of "clinical remission" (a low overall symptom score, minimal bleeding, and a near-normal bowel lining on camera), compared with 4.1% in the placebo group. For "clinical response" — meaning a meaningful reduction in symptoms and bleeding — the reported figures were 74.5% for upadacitinib versus 25.4% for placebo. When looking at the bowel lining on camera alone, 44.0% of the upadacitinib group showed "endoscopic improvement" (a score of 0 or 1) versus 8.3% for placebo, and 18.2% versus 1.7% reached full "endoscopic remission" (a score of 0, meaning the lining looked normal). At the earlier 2-week check, 63.3% on upadacitinib versus 25.9% on placebo showed a meaningful reduction in stool frequency and bleeding. A measure combining both camera and tissue-sample findings at week 8 showed improvement in 36.7% on upadacitinib versus 5.9% on placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02536404 · results posted 26 November 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02536404) was an extension study that followed on from an earlier trial. It enrolled 118 participants in total — 112 people who received a daily 2 mg dose of etrasimod and 6 who received a placebo (a dummy treatment with no active ingredient). Of those, 92 people in the etrasimod group and 5 in the placebo group completed the study. The trial was measuring how participants with ulcerative colitis fared over a longer period, tracking both unwanted medical events and disease scores related to bowel symptoms and gut inflammation. The reported data shows that the primary focus was on counting participants who experienced unwanted medical events during the study. In the etrasimod group, 67 out of 112 participants experienced at least one such event, compared with 5 out of 6 in the placebo group. Serious medical events — meaning those involving hospitalisation, being life-threatening, or other significant outcomes — were reported in 7 participants taking etrasimod and none in the placebo group. For the secondary measures, which used a scoring system to assess disease symptoms and gut appearance, the reported data shows that 78.6% of etrasimod participants and 75.0% of placebo participants met the criteria for a meaningful improvement in symptoms at Week 46. Around 39.3% of those on etrasimod and 25.0% on placebo met the stricter definition of having very low or minimal disease activity (called clinical remission). Among those who had already shown improvement at an earlier point in the preceding study, 39.3% on etrasimod and 50.0% on placebo maintained that improvement, while 14.3% on etrasimod and none on placebo maintained full remission through to Week 46. It is worth noting that the placebo group was very small (only 6 people), so percentage comparisons between the two groups should be read with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02709694 · results posted 25 October 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02709694) enrolled 33 adults with Crohn's disease, and all 33 completed the study. The trial was measuring how often a type of joint inflammation called sacroiliitis — inflammation of the joints where the spine meets the pelvis — could be detected on MRI scans in people with Crohn's disease, and whether that related to whether they had back pain. Participants were grouped into those who reported any back pain (19 people) and those who did not (14 people). The scans were reviewed by three specialist doctors using several different methods to assess for signs of inflammation and structural changes in the joints. The reported data shows that, using the main "global assessment" scoring method (where at least two out of three reviewing doctors had to agree), 4 out of 19 people in the back pain group had MRI results considered positive for sacroiliitis, while none of the 14 people in the no-back-pain group did. Using a different scoring approach called "Morpho" (based on detecting bone swelling and/or erosion on the scan), 5 people in the back pain group and 1 in the no-back-pain group were recorded as positive. A third method called "SPACE" (based on erosion and fatty changes) found zero positive results in either group. For a secondary measure, 13 out of 19 people in the back pain group were recorded as meeting criteria for a related spinal condition called axial spondyloarthritis. The reported data also shows that 14 people in the back pain group and 4 in the no-back-pain group had current joint pain in other parts of the body (peripheral arthritis). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01470612 · results posted 17 September 2021

  According to the results reported on ClinicalTrials.gov, this long-term trial (NCT01470612) looked at tofacitinib in two dose groups: 175 people took the lower dose (5 mg twice daily) and 769 people took the higher dose (10 mg twice daily), giving a total of 944 participants. The trial was primarily measuring safety-related outcomes — that is, it was tracking unwanted medical events, serious infections, abnormal blood test results, changes in vital signs (like blood pressure and heart rate), physical examination changes, and heart tracing (ECG) abnormalities that occurred while people were taking the study drug. The follow-up period was lengthy, running up to about 81–85 months (roughly 7 years) depending on the dose group. The reported data shows that, among those in the lower-dose group, 154 out of 175 participants experienced at least one treatment-emergent adverse event (an unwanted medical occurrence that appeared or worsened after starting the study drug), while 626 out of 769 did so in the higher-dose group. Serious adverse events were recorded for 39 people in the lower-dose group and 147 in the higher-dose group. Serious infections — those needing hospital treatment or intravenous antibiotics — were reported in 8 people (lower dose) and 31 people (higher dose). Laboratory test abnormalities were recorded for 162 participants in the lower-dose group and 670 in the higher-dose group. Clinically significant physical examination changes were noted in 84 and 391 participants respectively. Various vital sign abnormalities (such as notable swings in blood pressure or pulse rate) were also recorded across both groups at different thresholds. The reported data shows that no participants in either group met the pre-defined thresholds for abnormal ECG readings across the three measures tracked. It is worth noting that a much higher proportion of participants did not complete the trial — 84 in the lower-dose group and 665 in the higher-dose group — though the reasons for not completing were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02435992 · results posted 1 September 2021

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called RPC1063 (also known as ozanimod) compared to a placebo (an inactive dummy treatment) in people with ulcerative colitis, a condition causing inflammation in the large bowel. The trial had two main stages: an induction period (the first 10 weeks, to see initial results) and a maintenance period (out to 52 weeks, to see longer-term results). In total, 429 participants started in one RPC1063 induction group, 216 in the placebo induction group, and a further 367 in a second RPC1063 induction group. Those who responded during the induction stage could then move into the maintenance stage, where 230 continued on RPC1063 and 227 were on placebo. The reported data shows that at 10 weeks, 18.4% of participants in the first RPC1063 induction group and 21.0% in the second RPC1063 induction group were recorded as being in "clinical remission" (meaning their symptoms had reduced to a very low level by a standard scoring system), compared with 6.0% in the placebo group. At 52 weeks, 37.0% of those who continued on RPC1063 in the maintenance period were in clinical remission, compared with 18.5% of those on placebo and 24.6% in the placebo-to-maintenance group. For "clinical response" (a broader measure of symptom improvement, not full remission), the reported data shows 47.8% and 52.6% in the two RPC1063 induction groups at 10 weeks, versus 25.9% for placebo; and 60.0% for RPC1063 versus 41.0% for placebo at 52 weeks. The reported data also shows figures for measures relating to the lining of the bowel. At 10 weeks, endoscopic improvement (improvement seen on a camera examination of the bowel) was recorded in 27.3% and 27.2% of the two RPC1063 groups respectively, compared with 11.6% in the placebo group. Mucosal healing (a more complete form of bowel lining recovery) was reported in 12.6% and 11.4% of the RPC1063 groups, compared with 3.7% for placebo. No mucosal healing or endoscopic improvement figures for the 52-week maintenance period were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03046056 · results posted 9 August 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03046056) enrolled 78 people with Crohn's disease across three groups: 28 received filgotinib 200 mg, 32 received filgotinib 100 mg, and 18 received a placebo (a dummy treatment with no active ingredient). The trial ran for 24 weeks and was primarily measuring how many participants reached "clinical remission" — meaning their Crohn's Disease Activity Index (CDAI) score, a standard symptom-based rating scale running from 0 to 600, fell below 150. The trial also used a type of detailed gut imaging (MRI scans) to look at inflammation in different sections of the small bowel. Not everyone completed the study: 16 finished in the 200 mg group, 16 in the 100 mg group, and 11 in the placebo group. The reported data shows that for the main (primary) outcome at week 24, 25% of participants in both the filgotinib 200 mg group and the filgotinib 100 mg group had CDAI scores below 150, compared with 16.7% in the placebo group. For the imaging-based measures (called MaRIA scores, where a lower score indicates less inflammation), the reported data shows that scores in a section of bowel called the terminal ileum changed by −1.8 points in the 200 mg group, +0.7 points in the 100 mg group, and +0.5 points in the placebo group from the start of the study — a negative number meaning a reduction in the score, and a positive number meaning an increase. In another bowel section (distal ileum), scores changed by −1.1, −0.5, and +0.5 points respectively. In the jejunum section, all three groups showed very small increases (around 0.4–0.6 points). For the percentage of participants whose imaging scores reached the remission threshold in the terminal ileum, the reported figures were 4.5% (200 mg), 6.7% (100 mg), and 6.3% (placebo); in the distal ileum, they were 10.0% (200 mg), 0% (100 mg), and 16.7% (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01716039 · results posted 23 June 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT01716039) looked at two doses of a medicine called methotrexate (MTX) — 12.5 mg and 25 mg — compared to a placebo (a dummy treatment with no active ingredient) in people with ulcerative colitis. A total of 22 people started the trial across the three groups: 4 in the placebo group, 8 in the 12.5 mg group, and 10 in the 25 mg group. By the end of the 18-week study, 17 people had completed it — 3, 6, and 8 from each group respectively. The reported data shows two main things were measured using scoring tools that rate how inflamed the bowel lining looks during a camera examination (colonoscopy). The primary measure was called the Modified Baron Score (rated 0–4, where a higher number means more severe disease). The reported average change in score from the start to week 18 was 0.7 points in the placebo group, 1.1 points in the 12.5 mg group, and 0.9 points in the 25 mg group — with a higher change meaning a greater reduction in the score from baseline. The secondary measure, called the UCEIS score (rated 0–8, again with higher meaning more severe), showed an average change of 0.5 points for placebo, 0.7 points for the 12.5 mg group, and 1.1 points for the 25 mg group. No further breakdown of what these differences mean statistically was included in the submitted data. It is worth noting that this was a very small trial, and the reported data does not include information on whether the differences between groups were considered statistically meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02100696 · results posted 15 June 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02100696) looked at a medicine called etrolizumab in people with ulcerative colitis. The trial had two main phases: an induction phase (the first 14 weeks) and a maintenance phase (continuing to week 66). In the induction phase, 130 people received etrolizumab in an open-label group (where everyone knew what they were getting), while 95 people received a dummy treatment (placebo) and 384 received etrolizumab in a blinded group (where neither participants nor doctors knew who was getting which treatment). Those who responded well during the induction phase then moved into the maintenance phase, where 259 people participated across three groups. The trial used a scoring system called the Mayo Clinic Score to measure disease activity, where lower scores indicate milder disease. The reported data shows that, at 14 weeks in the blinded induction phase, 18.5% of those taking etrolizumab met the trial's definition of remission (very low disease activity scores), compared with 6.3% of those on placebo. For the secondary measures at 14 weeks, the reported data shows that 18.8% of etrolizumab participants met the criteria for clinical remission versus 6.3% on placebo; 45.8% of etrolizumab participants showed a meaningful improvement in their overall score (called a clinical response) compared to 31.6% on placebo; 33.3% of etrolizumab participants showed improvement in bowel lining appearance on camera (endoscopy) versus 25.3% on placebo; and 17.2% of etrolizumab participants had an endoscopy score of zero (the best possible) compared to 9.5% on placebo. For the maintenance phase, among participants who had responded to etrolizumab during the first 14 weeks and then continued into the longer phase, the reported data shows that 24.1% of those who continued on etrolizumab were in remission at week 66, compared to 20.2% of those who were switched to placebo during the maintenance phase. Results for the open-label induction group and for placebo responders in the maintenance phase were not reported for the primary remission outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03107793 · results posted 19 May 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03107793) enrolled 498 people with Crohn's disease, who all received an intravenous infusion of a medicine called ustekinumab at the start of the study. After that initial 16-week period, participants were randomly assigned to one of two approaches for the next 32 weeks (up to Week 48): a "treat to target" group (219 people), where treatment decisions were guided by regular internal camera examinations of the bowel (endoscopies), or a "routine care" group (221 people), where treatment was managed in the usual clinical way without those scheduled endoscopy targets. A further extension period ran to Week 104 for those who continued. The trial was primarily measuring how many participants showed a meaningful improvement on camera examination of their bowel — specifically, at least a 50% reduction in a bowel inflammation score — by Week 48. The reported data shows that for the main outcome at Week 48, 37.9% of participants in the treat-to-target group and 29.9% in the routine care group showed that level of improvement on camera examination. Several additional measures were also reported. When looking at symptom-based scores (using a tool called the Crohn's Disease Activity Index, which runs from 0 to around 600, with higher numbers meaning more active disease), the reported data shows that at Week 48, around 68.0% of the treat-to-target group and 77.8% of the routine care group met the threshold for a meaningful symptom response; and around 61.6% versus 69.7% respectively were recorded as being in symptom remission (a score below 150). For bowel camera remission — defined as a very low inflammation score of 2 or under — the reported figures at Week 48 were 11.4% for the treat-to-target group; the corresponding figure for the routine care group at that specific time point was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03259334 · results posted 7 May 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03259334) enrolled 380 adults across three groups: 76 received a placebo (a dummy treatment with no active ingredient), 153 received a 25 mg dose of a medicine called ontamalimab, and 151 received a 75 mg dose of ontamalimab. The trial was studying people with ulcerative colitis, a condition causing inflammation in the large bowel. The main thing the trial set out to measure was how many participants reached "remission" — meaning their bowel symptoms and the appearance of their bowel lining (as seen on a camera test called an endoscopy) had improved to a low level — after 12 weeks. The reported data shows that for the primary goal of remission at 12 weeks, 12 out of 76 people in the placebo group, 28 out of 153 in the 25 mg group, and 45 out of 151 in the 75 mg group met that definition. For the secondary measures, the reported data shows: endoscopic remission (improvement seen on the camera test alone) was recorded in 16, 42, and 62 participants respectively; clinical remission (symptom-based improvement in stool frequency and bleeding) was recorded in 29, 61, and 76 participants; a meaningful clinical response (a notable drop in overall symptom score) was recorded in 34, 76, and 99 participants; mucosal healing (combining the camera test result and a tissue sample score) was recorded in 13, 35, and 51 participants; and remission using a broader scoring system that also included a doctor's overall assessment was recorded in 11, 25, and 40 participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00317356 · results posted 30 April 2021

  According to the results reported on ClinicalTrials.gov, this trial tested three different doses of an investigational drug called OPC-6535 (12.5 mg, 25 mg, and 50 mg) against a placebo (inactive treatment) in people with ulcerative colitis. A total of 43 participants were enrolled across the four groups, with 36 completing the study. The trial's main goal was to measure what proportion of participants showed "clinical improvement" after 8 weeks — defined as a reduction in rectal bleeding scores and an improvement in how the bowel lining looked on examination. The reported data shows that the clinical improvement rate after 8 weeks was 27.3% in the 12.5 mg group, 30.0% in the 25 mg group, 50.0% in the 50 mg group, and 9.1% in the placebo group. For the secondary outcomes, remission rates (where both rectal bleeding and bowel appearance scores returned to zero) at 8 weeks were reported as 0% for the 12.5 mg group, 9.1% for the 25 mg group, 10.0% for the 50 mg group, and 9.1% for the placebo group. Disease activity scores (measured on a 0–12 scale, where lower is less severe) also changed across all groups over 8 weeks, with reported average reductions of 2.6 points (12.5 mg), 1.9 points (25 mg), 3.8 points (50 mg), and 1.4 points (placebo). The reported data also shows that quality-of-life scores (measured on a scale of 32–224, where higher means better quality of life) increased in all groups after 8 weeks, with average increases of 22.5 points (12.5 mg), 7.1 points (25 mg), 16.0 points (50 mg), and 9.3 points (placebo). It is worth noting that this was a small study with fewer than 15 people in each group, so the numbers reflect a limited sample. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03559517 · results posted 29 April 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03559517) enrolled 29 people with Crohn's disease across three groups: 8 received a placebo (a dummy treatment with no active ingredient), 9 received a lower dose of ontamalimab (25 mg), and 12 received a higher dose (75 mg). The trial was measuring two main things at the 16-week mark: whether participants reached "clinical remission" based on their own daily reports of abdominal pain and stool frequency, and whether a camera examination of the bowel (endoscopy) showed a meaningful reduction in signs of disease activity. A number of secondary measures were also tracked, including remission based on a standard Crohn's disease scoring tool and broader definitions of response to treatment. The reported data shows the following numbers for the two primary measures at Week 16. For clinical remission based on participants' own daily symptom reports (pain and stool type): 1 out of 8 placebo participants, 2 out of 9 in the 25 mg group, and 1 out of 12 in the 75 mg group met this definition. For endoscopic response (a 25% or greater reduction in bowel inflammation score seen on camera): 3 out of 8 placebo participants, 4 out of 9 in the 25 mg group, and 5 out of 12 in the 75 mg group met this definition. For the secondary measures, the reported data shows similar small numbers across groups — for example, remission based on the standard Crohn's disease scoring tool was reached by 3, 4, and 3 participants in the placebo, 25 mg, and 75 mg groups respectively, and the broadest measure of clinical response (improvement in either pain or stool frequency) was reported in 4, 8, and 6 participants across the same groups. It is worth noting that this was a very small trial, with fewer than 30 people in total, which limits what can be drawn from the raw numbers alone. The reported data shows counts of participants meeting each definition — it does not on its own indicate whether any differences between groups are meaningful beyond chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02914522 · results posted 21 April 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02914522) tested a medicine called filgotinib in people with ulcerative colitis — a condition causing inflammation in the large bowel. The trial had two parts: an **induction phase** (about 10–11 weeks) where participants took either filgotinib 200 mg, filgotinib 100 mg, or a dummy pill (placebo) to see how the medicine performed short-term, and a **maintenance phase** (up to week 58) where those who responded were re-assigned to continue filgotinib or switch to a placebo. Two separate groups of participants — called Cohort A and Cohort B — took part in the induction phase. In total, roughly 1,350 people were enrolled across the induction phase, and around 664 went on to the maintenance phase. The reported data shows that the main thing being measured was a combined score called "EBS remission" — meaning a person's bowel lining looked close to normal on camera, they had no visible rectal bleeding, and their number of daily stools had improved. At week 10 of the induction phase, the percentage of participants reported to have reached this point was: **26.1%** on filgotinib 200 mg and **19.1%** on filgotinib 100 mg, compared with **15.3%** on placebo (Cohort A); and **11.5%** on filgotinib 200 mg and **9.5%** on filgotinib 100 mg, compared with **4.2%** on placebo (Cohort B). In the maintenance phase at week 58, the reported figures were **37.2%** (filgotinib 200 mg) versus **11.2%** (placebo), and **23.8%** (filgotinib 100 mg) versus **13.5%** (placebo). Secondary measures — including a broader disease score, bowel lining appearance alone, and microscopic tissue assessment — showed broadly similar patterns across the groups, with the reported numbers available in the full ClinicalTrials.gov record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02163759 · results posted 5 April 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02163759) enrolled 358 adults in total — 72 received a placebo (an inactive treatment), 142 received adalimumab, and 144 received etrolizumab. The trial was measuring how many participants with ulcerative colitis (a condition causing inflammation of the large bowel) reached "remission" — meaning their disease activity score dropped to a very low level — after 10 weeks. Disease activity was measured using a tool called the Mayo Clinic Score, which combines bowel frequency, bleeding, an internal camera examination of the bowel, and a doctor's overall assessment, with higher scores meaning more severe disease. The reported data shows that at Week 10, 19.4% of participants taking etrolizumab met the remission definition, compared with 6.9% in the placebo group and 22.5% in the adalimumab group. When results from this trial were pooled with a companion trial, the reported remission figures were 18.8% for etrolizumab and 23.5% for adalimumab. For a separate measure called "clinical response" — meaning a meaningful reduction in the overall score rather than full remission — the reported Week 10 figures were 56.9% for etrolizumab, 52.1% for adalimumab, and 50.0% for placebo in this trial alone. Regarding improvement in the appearance of the bowel lining on camera, 40.3% of the etrolizumab group, 33.1% of the adalimumab group, and 22.2% of the placebo group met that measure at Week 10. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02447302 · results posted 5 April 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02447302) enrolled 156 adults with ulcerative colitis — a condition causing inflammation of the large bowel. Participants were randomly assigned to one of three groups: 52 people received a lower dose of etrasimod (1 mg), 50 received a higher dose (2 mg), and 54 received a placebo (a dummy treatment with no active ingredient). The trial ran for 12 weeks and measured changes in disease activity using standard scoring tools that rate symptoms such as bowel frequency, rectal bleeding, and the appearance of the bowel lining on camera — with higher scores meaning more severe disease. The reported data shows that, for the main measure — a combined disease activity score out of 9 — all three groups had lower (improved) scores at week 12 compared to where they started. The 1 mg etrasimod group's score fell by an average of 1.94 points, the 2 mg group's fell by 2.49 points, and the placebo group's fell by 1.50 points. For the secondary measures, the reported data shows that 22.5% of participants in the 1 mg group and 41.8% in the 2 mg group had an improved bowel-lining appearance on camera by week 12, compared with 17.8% in the placebo group. On a broader disease activity score out of 12, the average reductions were 2.69 points (1 mg), 3.35 points (2 mg), and 2.08 points (placebo). The proportion of participants who met the criteria for clinical remission — meaning their symptoms had reduced to near-normal levels across several measures — was reported as 16.0% (1 mg), 33.0% (2 mg), and 8.1% (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02895100 · results posted 22 March 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02895100) tested three different daily doses of an investigational oral medication called PTG-100 — 150 mg, 300 mg, and 900 mg — compared to a placebo (a dummy treatment with no active ingredient) in people with ulcerative colitis, a condition causing inflammation of the bowel. A total of 98 people started the trial across the four groups (25, 25, 23, and 25 participants respectively). Not everyone finished the study — 58 people completed it in total, with 14, 14, 15, and 15 completing in each group. The main thing the trial was measuring was the proportion of participants who reached "clinical remission" by week 12 — meaning their bowel symptoms (stool frequency, rectal bleeding, and results of a bowel camera examination) had improved to a defined level. The reported data shows that the number of participants recorded as reaching clinical remission at week 12 was: 1 person in the 150 mg PTG-100 group, 2 people in the 300 mg group, 3 people in the 900 mg group, and 4 people in the placebo group. No secondary outcome measure data was reported in the submitted results. It is worth noting that these are small numbers across all groups, and the trial did not report any additional outcome measures in the data submitted to ClinicalTrials.gov — so further detail was not available to summarise here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02171429 · results posted 5 March 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02171429) enrolled 358 people in total: 72 received a placebo (an inactive treatment), 143 received adalimumab (an existing medicine), and 143 received etrolizumab (the investigational medicine being studied). The trial was primarily looking at how many participants reached "remission" — meaning their disease activity score dropped to a very low level — by Week 10, using a scoring tool called the Mayo Clinic Score, which combines measures such as stool frequency, rectal bleeding, and results from a bowel camera examination. The vast majority of participants completed the study. The reported data shows that, for the main question the trial was designed to answer — remission at Week 10 comparing etrolizumab to placebo — 18.2% of participants in the etrolizumab group and 11.1% in the placebo group reached remission. When etrolizumab was compared to adalimumab on that same remission measure, the reported figures were 18.2% for etrolizumab and 24.5% for adalimumab. In a larger pooled analysis combining this trial with a related study, the remission figures were 18.8% for etrolizumab and 23.5% for adalimumab. For "clinical response" (a broader improvement measure, not full remission) at Week 10, the reported data shows 52.4% for etrolizumab, 54.5% for adalimumab, and 38.9% for placebo. Improvement in the appearance of the bowel lining on camera was reported in 39.9% of the etrolizumab group, 42.7% of the adalimumab group, and 30.6% of the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01804166 · results posted 4 March 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1 participant who had been diagnosed with both inflammatory bowel disease (IBD) and a rare type of blood cancer called hepatosplenic T-cell lymphoma (HSTCL). The study was set up to collect biological samples from such patients, with the goal of banking those samples for future research to look for biological markers — measurable signals in the body — that might one day help identify who is at risk of developing HSTCL, or potentially detect it earlier. The reported data shows that the trial's primary outcome was the number of samples collected from IBD patients diagnosed with HSTCL. However, no numerical measurement results were reported in the data submitted to ClinicalTrials.gov for this outcome. The 1 participant who entered the study completed it, with none recorded as dropping out. Beyond that, the data does not provide further detail about what the collected samples contained or any findings from them. Because no outcome measurement figures were actually reported in the submitted data, it is not possible to describe what the sample collection revealed. This appears to have been a very small sample-collection study rather than a trial testing a treatment, and any future analysis of the collected samples was not captured in this record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01831427 · results posted 1 February 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT01831427) tested a drug called andecaliximab in a total of 74 participants across several groups. Some participants received andecaliximab as a drip into the vein (intravenous, or IV) at different dose levels, and one group received it as an injection under the skin (subcutaneous, or SC). Others received a placebo (a dummy treatment with no active drug). The trial was split into two parts: a "single ascending dose" (SAD) phase, where each person received one dose, and a "multiple ascending dose" (MAD) phase, where people received repeated doses over time. The trial was measuring two main things: how many participants experienced unwanted health events after taking the drug (called treatment-emergent adverse events, or TEAEs), and how the drug moved through the body over time (called pharmacokinetics — essentially tracking how much drug was in the blood and for how long). The reported data shows that, for the single-dose (SAD) part, between 0% and 60% of participants in the andecaliximab IV dose groups experienced at least one TEAE, compared with 25% in the pooled placebo group. When all andecaliximab IV single-dose groups were combined, the reported figure was 25%. For the repeated-dose (MAD) part, between 25% and 75% of participants in the andecaliximab IV groups experienced a TEAE, with a combined figure of 56.3% across all IV groups, and 50% in the 150 mg under-the-skin group. The placebo group figures for TEAEs in the MAD part were not reported in the submitted data. Regarding how the drug behaved in the blood, the reported data shows that the peak blood concentration (the highest level of drug measured) rose with higher doses — for example, in the single-dose part, peak levels ranged from 9.4 micrograms per millilitre at the lowest dose to 210.0 micrograms per millilitre at the highest dose. Similar patterns were seen in the repeated-dose groups. Some blood-level figures for the lowest doses were listed as not available (NA) in the submitted data, meaning those results were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01647516 · results posted 14 October 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 199 participants across three groups during the initial eight-week "induction" phase: 66 received a placebo (a dummy treatment with no active ingredient), 66 received a lower dose of ozanimod hydrochloride (0.5 mg), and 67 received a higher dose (1 mg). Participants who showed a response during that phase could continue into a longer "maintenance" phase lasting until week 32, and then into an open-label period where everyone received the active treatment. The trial was measuring whether ozanimod could bring participants' ulcerative colitis disease activity into "remission" — meaning their symptoms and bowel lining appearance scored very low on a standard disease rating tool called the Mayo Score (which runs from 0 to 12, where lower numbers mean less severe disease). The reported data shows that at week 8, the percentage of participants recorded as being in clinical remission was 6.2% in the placebo group, 13.8% in the 0.5 mg group, and 16.4% in the 1 mg group. When looking at "clinical response" — a meaningful improvement in the Mayo Score even if full remission was not reached — the reported figures were 36.9% for placebo, 53.8% for the 0.5 mg group, and 56.7% for the 1 mg group. The reported data also shows that the average change in Mayo Score from the start to week 8 was a reduction of 2.0 points for the placebo group, 2.6 points for the 0.5 mg group, and 3.4 points for the 1 mg group. For "mucosal healing" — defined as the bowel lining appearing close to normal on a camera examination — the reported percentages at week 8 were 12.3% (placebo), 27.7% (0.5 mg), and 34.3% (1 mg). By week 32, the reported data shows that the percentage of participants in clinical remission was 6.2% for the placebo group, 26.2% for the 0.5 mg group, and 20.9% for the 1 mg group. Clinical response at week 32 was reported as 20.0% for placebo, 35.4% for the 0.5 mg group, and 50.7% for the 1 mg group. It is worth noting that by week 32 only participants who had responded during the earlier induction phase continued in the trial, so these groups were smaller than at the start. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02065557 · results posted 5 October 2020

  According to the results reported on ClinicalTrials.gov, this trial looked at a treatment for ulcerative colitis — a condition causing inflammation in the large bowel. The trial had two main stages: an induction period (the first 8 weeks, where participants received the treatment to see if their symptoms would respond) and a maintenance period (up to week 52, where those who responded were followed to see if their condition stayed under control). A total of 101 people started the induction stage across three groups — a standard dose group (32 people), a higher dose group (51 people), and a higher dose open-label group (18 people, meaning everyone knew what they were receiving). Of those, 81 participants moved into the maintenance stage, where they were divided into three groups: placebo (a dummy treatment with no active ingredient), standard dose, and high dose. Disease activity was measured using scoring tools that track symptoms like bowel movement frequency and bleeding, as well as internal camera (endoscopy) findings. The reported data shows that at week 8, the percentage of participants whose symptoms reached remission (meaning their disease activity score fell to a very low level) was 43.3% in the standard dose group, 59.6% in the high dose group, and 68.8% in the open-label high dose group. For the maintenance stage at week 52 — looking only at people who had responded by week 8 — the reported remission rates were 33.3% in the placebo group, 29.0% in the standard dose group, and 45.2% in the high dose group. For secondary measures at week 52, the reported data shows that clinical response (a meaningful drop in the disease activity score) was recorded in 33.3% of the placebo group, 61.3% of the standard dose group, and 67.7% of the high dose group. Mucosal healing (a low score on the camera examination of the bowel lining) was reported in 33.3%, 38.7%, and 51.6% of those same groups respectively. Figures for remission among those who were already in remission at week 8, and for remission without the use of steroid medicines, were also reported and followed a broadly similar pattern across groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02611817 · results posted 23 June 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02611817) looked at a medication called vedolizumab in people with Crohn's disease, a type of inflammatory bowel condition. A total of 644 people started an initial open treatment phase, all receiving vedolizumab given through a drip (intravenous infusion). Of those, 594 completed that phase. Participants who responded were then moved into a second, blinded phase — meaning neither they nor their doctors knew which treatment they were getting — where 135 people received a dummy (placebo) injection and 275 received vedolizumab as a self-administered injection under the skin. The trial was primarily measuring how many people reached what researchers called "clinical remission" (a low disease-activity score on a standard rating tool) by Week 52. The reported data shows that, for the main outcome at Week 52, 34.3% of participants in the placebo group and 48.0% in the vedolizumab injection group had scores low enough to be counted as being in clinical remission. For one of the secondary outcomes — a meaningful improvement in their disease score (a drop of at least 100 points on the rating scale) — the reported figures were 44.8% for the placebo group and 52.0% for the vedolizumab injection group. The trial also looked at how many people who were taking steroid tablets at the start were able to stop steroids and still be in remission by Week 52; the reported data shows 18.2% in the placebo group and 45.3% in the vedolizumab injection group met that measure. Finally, among participants who had never previously tried a type of medicine called a TNF-alpha antagonist (an older class of treatment for Crohn's disease), 42.9% in the placebo group and 48.6% in the vedolizumab injection group were reported to be in remission at Week 52. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03488030 · results posted 12 June 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 246 people in total — 101 with Crohn's disease and 145 with ulcerative colitis. All 246 participants completed the study period, with none recorded as having dropped out. The trial was observational in nature, meaning it was set up to describe and record the characteristics of people living with these two inflammatory bowel conditions, rather than to test a new treatment. Among the things it measured were how many participants had active (flaring) disease at the start of the study, their body weight and body mass index (a measure of body weight relative to height), their medical history, and how their disease was classified in terms of location and behaviour. The reported data shows that at the first study visit (Day 1), 9.3% of the Crohn's disease participants were recorded as having active disease based on standard scoring tools, while 7.7% of the ulcerative colitis participants were recorded as having active disease. When looking at steroid use patterns among those with moderate-to-severe disease, the numbers reported ranged across several categories for both groups. For body weight category, among those with moderate-to-severe disease, the reported data shows that height and weight figures were not reported for some sub-categories, but 54 Crohn's disease participants and 55 ulcerative colitis participants fell into the normal weight range, 33 and 55 respectively were in the overweight range, and 11 and 27 were in the obese range. Regarding medical history, 49 Crohn's disease and 74 ulcerative colitis participants had a recorded history of extra intestinal manifestations (symptoms outside the gut) or other health conditions, while 52 and 71 respectively did not. The reported data also shows that for the Crohn's disease group, the location and behaviour of disease varied across participants, with 52 recorded as having disease affecting both the small intestine and large intestine, 35 recorded with a non-narrowing, non-penetrating disease pattern, and smaller numbers falling into other classification categories. These figures describe the make-up of the study group rather than the outcome of any treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02566889 · results posted 9 June 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02566889) looked at children and young people with either Crohn's disease or ulcerative colitis — two types of inflammatory bowel disease. A total of 53 participants were enrolled: 45 in a "Reference Group" and 8 in a "Dose Escalation Group." The Dose Escalation Group was the focus of the main measurements, as the trial was examining what happened when the dose of the study treatment was increased for participants whose disease had not responded well enough at a standard dose. Of those who started, 32 in the Reference Group and 3 in the Dose Escalation Group completed the study. The reported data shows that, for the primary outcomes measured at 16 weeks after the dose increase, 4 out of the participants in the Dose Escalation Group with Crohn's disease met the trial's definition of a "clinical response" — meaning their disease activity score (called the PCDAI, a tool that combines symptoms, physical examination findings, and lab results into a number from 0 to 125, where higher means more active disease) had dropped by a meaningful amount. For participants with ulcerative colitis in the Dose Escalation Group, the reported data shows that 0 participants met the clinical response definition at 16 weeks, as measured by a separate scoring tool called the partial Mayo score. For a secondary outcome looking at whether a response was maintained all the way to 56 weeks, the reported data shows that 2 participants met that sustained response definition. Some other secondary outcome data — such as changes in abdominal pain and stool frequency scores — were reported for individual participants, but summary data for several of these measures was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02589665 · results posted 29 May 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02589665) tested a medicine called mirikizumab in people with ulcerative colitis — a condition causing ongoing inflammation in the large bowel. The trial ran in several stages. In the first stage (the "induction period"), 249 participants were divided into four groups: one group received a dummy treatment (placebo) given by drip into a vein every four weeks, and three groups received different doses of mirikizumab (50 mg, 200 mg, or 600 mg) by the same method. Those who responded then moved into a "maintenance period" in a separate set of groups, and there were also extension phases that enrolled additional participants. The trial measured things like how many people reached "clinical remission" — meaning their bowel symptoms and an internal camera examination of the bowel both showed very low disease activity — as well as how people's quality of life changed. The reported data shows that at 12 weeks, the percentage of participants recorded as being in clinical remission (the primary measure) was 4.8% in the placebo group, 15.9% in the 50 mg mirikizumab group, 22.6% in the 200 mg group, and 11.5% in the 600 mg group. For a secondary measure — the proportion who showed a meaningful improvement in symptoms without necessarily reaching full remission ("clinical response") — the reported figures were 20.6% for placebo, 41.3% for 50 mg, 59.7% for 200 mg, and 49.2% for 600 mg. The proportion whose bowel camera findings returned to completely normal (endoscopic remission) at 12 weeks was low across all groups: 1.6% (placebo), 3.2% (50 mg), 3.2% (200 mg), and 1.6% (600 mg). In the maintenance stage at 52 weeks, endoscopic remission was reported in 7.7% of the placebo group, 14.9% receiving mirikizumab every four weeks, and 28.3% receiving mirikizumab every 12 weeks. Quality-of-life scores (measured by bowel disease and general health questionnaires) showed increases from starting levels across all groups at 12 weeks, with the reported figures varying by dose and questionnaire. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02574637 · results posted 15 May 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02574637) tested a medicine called brazikumab in people with Crohn's disease, a condition that causes ongoing inflammation in the digestive tract. The trial compared four different doses of brazikumab against a placebo (a dummy treatment with no active ingredient). A total of 29 people took part in the first, blinded phase — where neither participants nor researchers knew who was receiving which treatment — split across the five groups (5 on placebo, 5 on the highest dose, 9 on a high-medium dose, 7 on a low-medium dose, and 3 on the lowest dose). A smaller number of participants then moved into an open-label phase, where everyone received brazikumab at a set dose of 210 mg. The main thing the trial was measuring was how many participants reached a specific score on a Crohn's disease activity scale (called the CDAI) low enough to be considered "in remission" — meaning their disease activity had dropped to a very low level — by week 8. The reported data shows that for the primary measure at week 8, none of the participants in the placebo group, the highest-dose group, or the low-medium dose group reached remission (0%). In the high-medium dose group, 22.2% of participants reached remission, and in the lowest-dose group, 33.3% did. For secondary measures, the reported data shows varying results across groups. For example, when looking at whether participants' CDAI scores dropped by at least 100 points (called a "response"), the figures reported ranged from 0% in the placebo group at one time point up to 77.8% in the high-medium dose group. Results for measures related to stool consistency and a camera-based assessment of the bowel (called an endoscopy score) were also reported across time points, with figures varying considerably between groups and time points. It is worth noting that the number of participants in each group was very small — some groups had as few as three people — which means the reported percentages should be interpreted with that context in mind. Some data points for certain time points and groups were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01951326 · results posted 1 May 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT01951326) enrolled 331 people with Crohn's disease — 166 received an investigational antibiotic combination called RHB-104, and 165 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring "remission" at 26 weeks, meaning whether a participant's Crohn's Disease Activity Index (CDAI) score — a standard tool used to gauge how active someone's Crohn's disease symptoms are — fell below 150 points, which is the threshold considered remission. By the end of the study, 87 participants in each group had completed the full course. The reported data shows that at the 26-week mark (the main measurement point), 61 out of 166 participants in the RHB-104 group met the remission threshold, compared with 37 out of 165 in the placebo group. For the secondary measures, the reported data shows that at week 26, 73 participants in the RHB-104 group and 50 in the placebo group had a CDAI score drop of at least 100 points (called a "response"). At week 16, remission was recorded in 70 RHB-104 participants versus 48 placebo participants, and at week 52, those numbers were 47 versus 32. The reported data also shows that 33 participants on RHB-104 and 21 on placebo maintained remission continuously from week 26 through to week 52. Finally, for the measure of being off steroids for at least three weeks while in remission at week 52, 11 participants in the RHB-104 group and 5 in the placebo group met that count. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02539368 · results posted 13 February 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02539368) followed 2,543 people in total across five groups. The groups were: people who received CT-P13 (1,522 participants), people who received Remicade (494 participants), people who switched from Remicade to CT-P13 (358 participants), people who switched from CT-P13 to Remicade (67 participants), and people who switched between the two treatments more than once (102 participants). All participants had been diagnosed with inflammatory bowel disease — either Crohn's disease or ulcerative colitis. The trial was an observational study, meaning it tracked real-world treatment patterns rather than randomly assigning treatments. It recorded things like how long people had lived with their disease, how often they switched between the two medicines, why they switched, and how their doses changed over time. The reported data shows that participants in the CT-P13-only group had been living with their disease for a median (middle value) of 63 months at the time they joined the study, compared to 112.5 months for those in the Remicade-only group and 120 months for those who switched from Remicade to CT-P13. Regarding switching: 237 people with Crohn's disease and 121 people with ulcerative colitis switched from Remicade to CT-P13; 47 people with Crohn's disease and 20 with ulcerative colitis switched from CT-P13 to Remicade; and 72 people with Crohn's disease and 30 with ulcerative colitis switched more than once. The reported data shows that dose changes (either an increase or a reduction) occurred in 479 participants in the CT-P13 group, 110 in the Remicade group, 89 in the Remicade-to-CT-P13 switchers group, 28 in the CT-P13-to-Remicade switchers group, and 31 in the multiple switchers group. The total dose amounts were listed as "not available" in the submitted data, so those figures were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02611830 · results posted 23 January 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02611830) involved 383 adults who all started with an open induction phase, receiving vedolizumab (300 mg) by intravenous (IV) drip. Of those, 353 completed that first phase. Participants who responded were then randomly placed into one of three maintenance groups for up to 52 weeks: 56 received a placebo (inactive treatment), 106 received vedolizumab as a subcutaneous (under-the-skin) injection at 108 mg, and 54 continued with the IV drip at 300 mg. The trial was primarily measuring how many participants reached "clinical remission" — meaning their disease activity score, measured by a standard tool called the Mayo score, fell to a very low level — by Week 52. The reported data shows the following results at Week 52. For the main outcome (clinical remission), 14.3% of the placebo group, 46.2% of the subcutaneous injection group, and 42.6% of the continued IV group met that measure. For the secondary outcomes, the reported data shows: mucosal healing (low inflammation seen on camera examination of the bowel) was recorded in 21.4% of the placebo group, 56.6% of the subcutaneous group, and 53.7% of the IV group. A "durable response" (improvement at both Week 6 and Week 52) was recorded in 28.6%, 64.2%, and 72.2% respectively. Durable remission at both time points was recorded in 5.4%, 15.1%, and 16.7% respectively. Among participants who were on corticosteroid tablets at the start and had stopped them by Week 52 while also in remission, the figures were 8.3%, 28.9%, and 28.6% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01882764 · results posted 13 January 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT01882764) enrolled 66 people in total — 47 received a treatment called HMPL-004 at a dose of 1,800 mg per day, and 19 received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether participants with ulcerative colitis reached "clinical remission," which the researchers defined as scoring very low on a standard symptom scale (called a modified Mayo Score) and having no rectal bleeding. The reported data shows that the primary outcome — the number of participants who achieved clinical remission — was zero in both groups. That means, according to the submitted results, no participants in either the HMPL-004 group or the placebo group met the criteria for clinical remission by the end of the study period. It is also worth noting that almost no participants were recorded as having "completed" the study in the conventional sense: zero in the HMPL-004 group and only one in the placebo group were marked as completed, with the remainder recorded as not completing the study. No secondary outcome data appears to have been reported in the submitted results. The reported data shows only this single primary outcome figure, and no additional measurements were included in the structured results submission. If there were other findings from this trial, they were not reported in the data submitted to ClinicalTrials.gov that is available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02407236 · results posted 23 December 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02407236) tested the medicine ustekinumab in people with ulcerative colitis. It ran in three back-to-back stages: an 8-week induction phase (where 961 people were enrolled across three groups — placebo, a fixed 130 mg intravenous dose, or a weight-based intravenous dose of approximately 6 mg/kg), a 44-week maintenance phase (involving 783 participants who moved forward from the induction stage), and a long-term extension of up to 176 weeks (involving 588 participants). The trial measured whether participants reached "clinical remission" — meaning their disease activity scores fell to a very low level — as well as other outcomes such as bowel endoscopy appearances and overall clinical response. The reported data shows the following numbers for the main outcomes. In the induction phase at Week 8, using one scoring method (the "global" definition of remission), 17 out of 319 placebo participants, 50 out of 320 in the 130 mg group, and 50 out of 322 in the weight-based dose group were reported to be in remission. Using a second scoring method (the "US" definition), those numbers were 20, 53, and 61 participants respectively. For a secondary measure — how many people showed improved bowel lining on endoscopy at Week 8 — the reported numbers were 44 (placebo), 84 (130 mg), and 87 (weight-based dose). For clinical response at Week 8, the reported figures were 100 (placebo), 164 (130 mg), and 199 (weight-based dose). In the maintenance phase at Week 44 (global definition), 42 out of 175 placebo participants, 66 out of 172 in the every-12-weeks group, and 77 out of 176 in the every-8-weeks group were reported in remission; the US definition gave similar figures of 43, 68, and 75 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02497469 · results posted 10 October 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02497469) enrolled 771 adults with ulcerative colitis — 386 received adalimumab (given as an injection under the skin) and 385 received vedolizumab (given as an intravenous drip). The trial compared these two treatments over 52 weeks, with the main thing being measured being whether participants reached "clinical remission" — meaning their disease activity score (called the Mayo score, a standardised tool that looks at bleeding, stool frequency, bowel lining appearance, and a doctor's overall assessment) fell to a very low level. By the end of the study, 217 participants in the adalimumab group and 270 in the vedolizumab group completed the full trial period. The reported data shows that for the primary outcome — clinical remission at week 52 — 22.5% of participants in the adalimumab group and 31.3% in the vedolizumab group met that threshold. For the first secondary outcome, mucosal healing (meaning the lining of the bowel looked largely normal on examination), the reported figures were 27.7% for adalimumab and 39.7% for vedolizumab. The second secondary outcome looked at a specific subgroup: participants who were taking steroid tablets at the start of the trial and who both stopped steroids and reached clinical remission by week 52. The reported data shows 21.8% in the adalimumab group and 12.6% in the vedolizumab group met this combined measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02240108 · results posted 10 September 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in the Rifaximin EIR 800 mg group and 46 people in the placebo (dummy treatment) group, though one placebo participant was later excluded from the main analysis group, leaving 45. By the end of the study, 21 people in each group had completed the trial. The trial was measuring whether a drug called Rifaximin EIR reduced symptoms of Crohn's disease — a condition causing ongoing gut inflammation — compared to a placebo. The main things being measured were stool frequency (the number of loose or very soft bowel movements over 7 days) and abdominal pain levels, assessed at both 16 weeks and 52 weeks. The trial also looked at whether the bowel lining showed signs of improvement on a camera examination (endoscopy) between weeks 16 and 17. The reported data shows the following numbers at the 16-week mark: when looking at stool frequency alone, 6 out of 35 people in the Rifaximin group and 8 out of 45 in the placebo group met the remission target. When looking at abdominal pain alone, 19 out of 35 in the Rifaximin group and 15 out of 45 in the placebo group met that target. When both stool frequency and pain had to be met at the same time, 5 in the Rifaximin group and 7 in the placebo group reached that combined target. For the endoscopy measure, 10 participants in each group showed a meaningful improvement in their bowel lining score. At the 52-week mark, the reported data shows that 7 in the Rifaximin group and 3 in the placebo group met the stool frequency remission target, while 9 in the Rifaximin group and 5 in the placebo group met the abdominal pain remission target. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01008410 · results posted 14 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 265 adults — 133 in the budesonide group and 132 in the placebo group. The trial was measuring how a medicine called budesonide compared to a dummy treatment (placebo) in people with ulcerative colitis. The main thing being measured was whether participants reached "remission" after six weeks — a combined assessment based on a colonoscopy score, the absence of rectal bleeding, and no worsening of how often they needed the toilet, all scored using a standard disease activity index. The reported data shows that after six weeks, 38.3% of participants in the budesonide group and 25.8% in the placebo group met the remission criteria. For the secondary measures, the reported figures were: no visible rectal bleeding at week 6 — 46.6% (budesonide) vs 28.0% (placebo); normal or only mildly abnormal colonoscopy score — 55.6% vs 43.2%; a combined symptom score meeting a specific low threshold — 41.4% vs 25.8%; and an overall disease score of 3 or less with meaningful improvement from the starting point — 45.9% vs 30.3%. The reported data also shows percentages of participants who had no rectal bleeding at various scheduled check-ins during the treatment period, ranging from roughly 6% to 21% in the budesonide group and 1.5% to 13.6% in the placebo group across those time points. It is worth noting that not everyone finished the trial — 108 of 133 people in the budesonide group and 116 of 132 in the placebo group completed it, and the reasons for not completing were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01694485 · results posted 27 June 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 359 people in total across five groups. Participants had ulcerative colitis and were given either a placebo (a dummy treatment) or one of four different doses of a drug called abrilumab. The trial was measuring how many people in each group reached certain milestones at 8 weeks, including "remission" (meaning their disease activity score dropped to a very low level on a standard rating scale) and "response" (meaning their score improved by a meaningful amount). It also looked at "mucosal healing" (whether the lining of the bowel appeared healthier on examination) and whether remission was maintained through to week 24. The reported data shows the following results at the 8-week mark for the primary goal — the percentage of participants in remission. In the placebo group, around 4.3% were in remission. For the abrilumab groups, the figures were: 0% (7 mg dose), 2.5% (21 mg dose), 13.3% (70 mg dose), and 12.7% (210 mg dose). For the secondary measure of "response" at week 8, the reported figures were 25.9% (placebo), 14.3% (7 mg), 50.0% (21 mg), 49.0% (70 mg), and 46.8% (210 mg). For mucosal healing at week 8, the figures were 21.6% (placebo), 14.3% (7 mg), 15.0% (21 mg), 32.7% (70 mg), and 29.1% (210 mg). The reported data also shows the percentage of participants who remained in remission at both week 8 and week 24 (called "sustained remission"): 2.6% for placebo, 0% (7 mg), 2.5% (21 mg), 8.2% (70 mg), and 3.8% (210 mg). All figures above reflect the raw, unadjusted numbers as submitted; adjusted figures (accounting for other factors) were also reported and were broadly similar. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01771809 · results posted 18 April 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 330 people with ulcerative colitis — a condition causing inflammation in the large bowel. Participants were split into two groups: 164 people received a lower dose of the study drug SHP647 (75 mg) and 166 received a higher dose (225 mg). The trial was measuring how participants' bodies responded to the drug over time, including any unwanted medical events they experienced, whether the bowel lining showed signs of healing at 16 weeks, and how much of the drug was detectable in the blood. Of those who started the trial, 93 people in the lower-dose group and 83 in the higher-dose group completed it. The reported data shows that when it came to unwanted medical events (called "adverse events" — meaning any health issue that occurred during the trial, whether or not it was thought to be related to the drug), 146 out of 164 participants in the 75 mg group and 147 out of 166 in the 225 mg group experienced at least one such event. Serious adverse events — those involving hospitalisation, life-threatening situations, or lasting disability — were recorded in 34 people in the lower-dose group and 40 in the higher-dose group. Twelve people in the 75 mg group and 23 in the 225 mg group stopped taking the drug due to these events. Regarding bowel lining appearance at week 16, the reported data shows that 27.4% of the lower-dose group and 29.5% of the higher-dose group met the study's definition of mucosal healing (a bowel lining score of 0 or 1 on a standard scale). The trial also tracked whether participants developed antibodies against the drug itself; small numbers in both groups did, with figures ranging from 0 to 9 participants depending on the time point and measurement type. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02520284 · results posted 10 April 2019

  According to the results reported on ClinicalTrials.gov, this trial tested a medicine called andecaliximab in people with ulcerative colitis (a condition causing inflammation of the large bowel). A total of 165 people took part in the initial eight-week blinded phase, split into three groups: 54 received andecaliximab every two weeks, 56 received it weekly, and 55 received a placebo (a dummy treatment with no active ingredient). The trial measured whether participants' bowel disease showed signs of improvement or remission — assessed through a combination of camera examinations of the bowel, bleeding scores, and stool frequency scores — after eight weeks of treatment. The reported data shows that for the main outcome (called "EBS clinical remission" — meaning the disease had settled to a low or inactive level based on the combined scores), approximately 7.4% of the every-two-weeks group, 1.8% of the weekly group, and 7.3% of the placebo group met this standard at eight weeks. For the secondary outcomes, the reported data shows similar patterns: around 7.4%, 1.8%, and 7.3% respectively achieved a broader remission measure; roughly 46.3%, 30.4%, and 30.9% showed a meaningful improvement on a combined score; and 18%, 13.7%, and 22% showed healing of the bowel lining as assessed under a microscope. Endoscopic remission (the bowel looking completely normal on camera) was recorded in 3.7%, 0%, and 5.5% respectively. The reported data shows that across most measures, the numbers in the andecaliximab groups were broadly similar to — or in some cases lower than — those in the placebo group. No data was reported for outcomes beyond the eight-week induction phase, as all participants in the subsequent maintenance phases were recorded as not completing those phases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02405442 · results posted 28 March 2019

  According to the results reported on ClinicalTrials.gov, this trial tested a medicine called andecaliximab in people with Crohn's disease, a condition causing ongoing inflammation in the digestive system. A total of 187 participants took part in the initial double-blind phase (where neither participants nor doctors knew who received which treatment). They were split into four groups: three groups received different doses or schedules of andecaliximab (53 people each), and one group of 28 people received a placebo (a dummy treatment with no active ingredient). The trial primarily looked at two things after eight weeks: whether participants reported fewer symptoms (measured by a symptom diary score) and whether a camera examination of the bowel showed improvement. The reported data shows the following results at the eight-week mark. For the symptom diary measure (called the PRO2 score), 17.0% of those on andecaliximab every two weeks, 13.2% on the weekly lower dose, and 11.3% on the weekly higher dose reached the target score, compared with 14.3% in the placebo group. For the bowel camera (endoscopy) measure, 11.3%, 13.2%, and 7.5% across the three andecaliximab groups respectively showed a meaningful improvement on their scan, compared with 10.7% in the placebo group. The reported data also shows results for two additional measures: a broader disease activity score (CDAI) showed 20.8%, 17.0%, and 11.3% across the three andecaliximab groups reaching the remission threshold, versus 21.4% for placebo; and for bowel lining healing, the figures were 5.7%, 1.9%, and 1.9% for the andecaliximab groups, compared with 7.1% for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01190410 · results posted 26 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01190410) looked at a medicine called certolizumab pegol in children and young people with Crohn's disease. Participants were placed into one of two groups based on their body weight — a lower-dose group (4 participants) and a higher-dose group (12 participants). A small number from the higher-dose group (2 participants) later entered a re-induction phase, where they received the treatment again. In total, 16 people started the study, and 6 completed it. The trial was measuring things like unwanted medical events that occurred during treatment, as well as certain blood markers and disease activity scores. The reported data shows that the primary thing being tracked was the number of participants who experienced at least one unwanted medical event (called a treatment-emergent adverse event, or TEAE — meaning any health incident that happened while on the study treatment, whether or not it was thought to be related to the medicine). According to the results reported on ClinicalTrials.gov, 2 out of 4 participants in the lower-dose group, 6 out of 12 in the higher-dose group, and 2 out of 2 in the re-induction group had at least one such event reported. The reported data shows that 2 participants in the higher-dose group stopped treatment because of a TEAE, while none did so in the other groups. Regarding blood markers, 3 participants in the higher-dose group developed a type of antibody called anti-nuclear antibodies (proteins the immune system can make that sometimes appear with certain medicines), while none in the lower-dose group did. No participants in either group developed a second type of antibody called anti-dsDNA antibodies. On a scale used to measure Crohn's disease activity in children, the reported data shows that 100% of the lower-dose group and approximately 44% of the higher-dose group met the score threshold defined as clinical remission at the time of measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00790933 · results posted 12 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT00790933) involved participants with inflammatory bowel disease (IBD) — specifically ulcerative colitis (UC) and Crohn's disease (CD) — who received a medicine called vedolizumab (300 mg). Across five participant groups drawn from earlier related studies, a total of 2,243 people started the trial. Of those, 766 completed it, while 1,477 did not complete it (the reasons for this were not broken down in the data provided here). The trial was primarily looking at the safety profile of vedolizumab over time — tracking unwanted medical events, unusual laboratory results, changes in vital signs, and heart tracing (ECG) findings. The reported data shows that 93% of UC participants and 96% of CD participants experienced at least one treatment-emergent adverse event (that is, any unwanted medical occurrence that happened after receiving the study drug). Serious adverse events — meaning those involving hospitalisation, life-threatening situations, lasting disability, or death — were reported in 31% of UC participants and 41% of CD participants. For laboratory results, the numbers of participants with markedly abnormal findings varied across different tests; for example, 42 UC participants and 37 CD participants had notably abnormal results for a liver/pancreas enzyme called lipase. Regarding vital signs such as blood pressure and heart rate, 0% of participants in either group had a clinically significant change recorded. Seven participants in each of the UC and CD groups had a clinically significant finding on their heart tracing (ECG). For the outcome measuring time to major IBD-related events (such as hospitalisations or surgeries), the data was listed as "not available" and was not reported. A quality-of-life questionnaire (scored from 32 to 224, where higher means better) showed scores broadly in the range of 122 to 132 across the different participant subgroups at week 28, though the starting (baseline) figures needed to calculate the full change were not separately provided in this dataset. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02596893 · results posted 23 January 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02596893) enrolled 701 adults with Crohn's disease across four groups: a placebo group (174 people) and three groups receiving different dosing regimens of a drug called GED-0301 (approximately 175–176 people each). The trial ran for up to 52 weeks and was measuring things like how many participants reached "clinical remission" (a standard scoring system dropping below a threshold that indicates low disease activity), how many had a meaningful improvement in symptoms ("clinical response"), and how many showed improvement on internal camera examination of the bowel. It is worth noting that very few participants completed the full double-blind 52-week period in any group — between 8 and 14 out of roughly 175 in each group. The reported data shows that at week 52, the percentage of participants reaching clinical remission was 5.3% in the placebo group, 2.5%, 9.4%, and 3.4% in the three GED-0301 groups respectively. For improvement seen on bowel camera examination at week 52, the figures were 3.5% (placebo), 0.8%, 1.6%, and 1.7% across the GED-0301 groups. At the earlier four-week mark, between roughly 15–20% of participants in every group — including placebo — had reached the remission threshold, and around 28–34% across all groups had shown a meaningful symptom improvement score. The reported data shows similarly small differences between groups at week 12 for symptom response (placebo 44.4%; GED-0301 groups 32–34%). For the measure of being in remission without using corticosteroids at week 52, figures ranged from 0.0% to 7.0% across the GED-0301 groups, compared with 2.2% for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02499783 · results posted 4 January 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 205 participants with Crohn's disease across two groups for the first eight weeks: 102 people received the active treatment (adalimumab, given as injections at set doses) and 103 people received a placebo (an inactive treatment used for comparison). The trial was measuring disease activity using a scoring tool called the CDAI — a scale generally ranging from 0 to 600, where a score below 150 is considered "remission" (meaning very low disease activity). After the first eight weeks, most participants who continued moved into an open-label phase (where everyone received the active treatment) lasting until week 26. The reported data shows that at week 4, approximately 37.3% of participants in the adalimumab group had reached the remission threshold (a CDAI score below 150), compared with 6.8% in the placebo group. When a combined measure was looked at — remission plus a notable drop in a blood marker of inflammation (called hs-CRP) — the reported figures were 33.3% for the adalimumab group and 0% for the placebo group at week 4. For the longer open-label phase, the reported data shows that among participants who had shown a meaningful improvement by week 8, around 64.6% had reached remission by week 26, and 55.0% had reached remission alongside a significant reduction in the hs-CRP blood marker. Among participants who had been taking steroid medicines at the start of the trial and who showed improvement by week 8, approximately 62.8% had reached remission and stopped using steroids by week 26, and 57.6% had done so while also showing a notable reduction in the hs-CRP marker. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02289417 · results posted 29 October 2018

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called apremilast in people with ulcerative colitis (a condition causing inflammation of the large bowel). A total of 170 people took part in the first 12-week phase, split into three groups: 58 received a placebo (a dummy treatment with no active ingredient), 57 received apremilast at a 30 mg dose, and 55 received apremilast at a 40 mg dose. The trial then continued in later phases for up to two years, with participants moving into different groups over time. The main thing the trial was measuring at 12 weeks was how many people reached "clinical remission" — meaning their disease activity score dropped to a very low level based on symptoms and a camera examination of the bowel. The reported data shows that at 12 weeks, 12.1% of people in the placebo group reached clinical remission, compared with 31.6% in the 30 mg apremilast group and 21.8% in the 40 mg apremilast group. For the secondary measures, the reported data shows that a "clinical response" (a meaningful improvement in scores, including reduced bleeding) was seen in 46.6% of the placebo group, 61.4% of the 30 mg group, and 67.3% of the 40 mg group. When looking specifically at bowel camera findings, remission (a completely normal-looking bowel lining) was reported in 3.4% of the placebo group, 8.8% of the 30 mg group, and 7.3% of the 40 mg group. A reduction in rectal bleeding to a low level was reported in 72.4% of the placebo group, 84.2% of the 30 mg group, and 87.3% of the 40 mg group. The reported data also shows that using a slightly different scoring method (one that leaves out the doctor's overall rating), remission at 12 weeks was recorded in 19.0% of the placebo group, 43.9% of the 30 mg group, and 27.3% of the 40 mg group. An improvement in the camera score of at least one point was seen in 41.4% of the placebo group, 73.7% of the 30 mg group, and 47.3% of the 40 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02601300 · results posted 12 September 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02601300) enrolled 41 participants who all received the study drug, mongersen, over a period of up to 52 weeks. The trial was studying mongersen as a potential treatment for ulcerative colitis — a condition causing inflammation in the large bowel. Participants were tracked across two phases: an initial 8-week induction phase (where 38 of the 41 who started completed it) and a longer extension phase (where 35 went on to participate, but only 18 completed it). The main thing the trial was measuring was how many participants reached "clinical remission" — meaning their disease activity score, based on bowel habits, bleeding, and internal camera findings, dropped to a very low level — by Week 8. The reported data shows that at Week 8, 17.1% of participants met the definition of clinical remission on the scoring tool used (called the Modified Mayo Score). For the secondary measures — additional things the trial tracked — the reported figures were as follows: 14.6% of participants met a slightly stricter version of remission that also required no visible rectal bleeding; 19.5% showed low scores on the internal camera (endoscopy) examination alone; and 36.6% showed a meaningful improvement in their overall disease activity score (called a "clinical response," meaning a notable reduction in score even if full remission wasn't reached). Around 31.7% showed an improvement of at least one point on the endoscopy score specifically. When the bowel was looked at section by section, the proportion with low endoscopy scores varied by location, ranging from 27.0% in the rectum and lower bowel to 80.0% in the upper part of the large bowel. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00573794 · results posted 19 December 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 585 people, all of whom received the medication adalimumab (given as injections either every other week or every week, depending on how each person responded). The trial was measuring disease activity in people with ulcerative colitis — a condition causing inflammation of the large bowel — using two standard scoring tools called the "Mayo score" and the "Partial Mayo score." These scores combine things like how often a person goes to the toilet, whether there is rectal bleeding, and a doctor's overall assessment of disease severity. A lower score means less severe disease, so a drop (negative change) in score over time is what the trial was tracking. Of the 585 who started, 255 completed the study and 330 did not. The reported data shows that at the start of the study, participants had an average Partial Mayo score of 2.5 and a full Mayo score of 3.5 (out of maximums of 9 and 12 respectively). Over the course of the trial, both scores showed a gradual downward trend, meaning scores decreased from where they started. By the final measurement point, the reported change from the starting score was –2.0 on both the Partial Mayo and the full Mayo scale. For the secondary measures — which looked at individual parts of the overall score — the reported changes from baseline were smaller, ranging from around –0.1 to –0.3 across different time points for subscores covering rectal bleeding, endoscopy findings (a camera examination of the bowel), and the doctor's overall assessment. A secondary measure also tracked the percentage of participants whose scores fell into a "remission" category (defined as a Partial Mayo score of 2 or below with no single subscore above 1). The reported data shows this figure ranged from 52.4% at one early time point up to 77.2% at another, with 100% reported at the final measurement point — though it is worth noting that only a small number of participants remained in the study at that last point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01470599 · results posted 16 October 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01470599) enrolled 150 people in total — 62 who took tofacitinib at a dose of 5 mg twice daily, and 88 who took tofacitinib at 10 mg twice daily. The trial was measuring how participants with Crohn's disease fared over 48 weeks, focusing on whether their disease went into remission (meaning their disease activity score dropped below a set threshold), how long remission lasted, and whether any serious heart-related or cancer-related events occurred. Of the 150 who started, 43 in the lower-dose group and 45 in the higher-dose group completed the study. The reported data shows that for the primary safety-related outcomes, an independent panel of experts reviewed potential heart-related events: zero events meeting the defined criteria were reported in the 10 mg group, and the data for the 5 mg group was not reported for this measure. For potential cancer events, zero were confirmed in the 5 mg group and one was confirmed in the 10 mg group. Regarding the main secondary outcome — the percentage of participants in remission at Week 48 — the reported figures were approximately 88% in the 5 mg group and 56% in the 10 mg group. For "sustained remission" (meaning remission at both Week 24 and Week 48), the reported figures were 75% in the 5 mg group and 34% in the 10 mg group. The reported data also shows results for smaller subgroups of participants who were already in remission at the start of this study, with remission rates at various time points ranging broadly across both dose groups. For the measure of time to relapse (disease returning) among those who started in remission, the estimated percentage who had relapsed by Week 48 was reported as approximately 25% in the 10 mg group; the corresponding figure for the 5 mg group at that time point was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02092285 · results posted 13 October 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 205 people who were being treated with a medicine called golimumab for ulcerative colitis, a condition that causes inflammation in the large bowel. The trial was measuring how participants responded to the treatment over roughly one year, across two phases: an induction phase (the first six weeks) and a maintenance and follow-up phase (continuing through to week 54). Of the 205 people who started, 170 completed the induction phase, and 60 completed the full maintenance and follow-up phase. The main thing the trial was measuring was the percentage of participants who showed a meaningful improvement in their symptoms by week 6 and kept that improvement at both week 30 and week 54. Symptom severity was tracked using a scoring system called the Partial Mayo Score, which looks at how often a person goes to the toilet, whether there is rectal bleeding, and a doctor's overall assessment — with a lower score meaning milder disease. The reported data shows that 24.9% of participants (roughly 1 in 4 of those who started the trial) met the criteria for this sustained response across both time points. No other outcome measure results were included in the data submitted to ClinicalTrials.gov for this trial, so further figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01277666 · results posted 19 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 608 people with Crohn's disease across three groups: 203 received a placebo (an inactive dummy treatment), 203 received a medicine called GSK1605786A at 500 mg once a day, and 202 received the same medicine at 500 mg twice a day. The trial was measuring how participants' Crohn's disease symptoms changed over 12 weeks, using a scoring system called the Crohn's Disease Activity Index (CDAI) — a scale based on symptom diaries and medical assessments where higher scores indicate more severe disease. By the end of the study, around 158, 144, and 153 people in each group respectively had completed the trial. The reported data shows that for the main measure — the percentage of participants whose CDAI score dropped by at least 70 points by week 12 — the figures were 25.1% in the placebo group, 27.6% in the once-daily medicine group, and 27.2% in the twice-daily medicine group. For the secondary measures, the percentage of participants whose symptoms reached the remission threshold (a CDAI score below 150) at week 12 was 15.3% for placebo, 13.3% for once-daily, and 12.9% for twice-daily. Similar patterns were seen at week 8 and when looking at participants who sustained a response across both week 8 and week 12, with the reported figures across all three groups remaining relatively close to one another in each case. The reported data shows that across all of the measured outcomes, the numbers recorded for the two medicine groups were broadly similar to those recorded for the placebo group at both time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01318993 · results posted 14 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 398 participants, all of whom received a treatment called GSK1605786A (taken as 500 mg twice a day). The trial was designed to monitor safety over time, with the main goal being to track any unwanted medical events (called adverse events) or serious unwanted medical events (serious adverse events) that participants experienced. The reported data shows that none of the 398 participants were recorded as having "completed" the study under the trial's own definitions — all 398 were listed as "not completed," which may reflect how the study was structured or ended rather than participants dropping out for a single reason. The reported data shows that, of those who received at least one dose, 303 out of the participants tracked experienced at least one adverse event (an unwanted medical occurrence during the study period), and 41 experienced at least one serious adverse event. The trial also tracked a range of physical measurements over time. Changes in blood pressure from the starting point were small and varied across different check-in weeks, ranging roughly from about −5 to +5 millimeters of mercury (a unit used to measure blood pressure). Heart rate changes from the starting point were also small, generally within about −8 to +2 beats per minute across the different time points. Blood and chemistry test results were also tracked, with the reported data showing the number of participants whose results shifted lower, stayed the same or returned to normal, or shifted higher compared to their starting values across a range of measurements including liver-related markers, blood cell counts, and other chemicals in the blood. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01316939 · results posted 7 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 229 people with Crohn's disease — a condition causing ongoing inflammation in the digestive tract. Participants were divided into three groups: 76 received a placebo (a dummy treatment with no active ingredient), 77 received the investigational medicine GSK1605786A at 500 mg once a day, and 76 received the same medicine at 500 mg twice a day. The trial ran for 52 weeks and was primarily measuring how many people achieved "clinical remission" — meaning their Crohn's disease symptom score (called the CDAI) dropped below a set threshold — at both the 28-week and 52-week points. It is worth noting that a large number of participants in each group did not complete the study, and the trial was ended early. The reported data shows that for the main outcome — the percentage of participants reaching remission at both weeks 28 and 52 — the placebo group had the highest figure at 10.5%, compared to 6.5% in the once-daily medicine group and 3.9% in the twice-daily medicine group. For a secondary outcome looking at remission while also not taking corticosteroids (a type of anti-inflammatory medicine) at those same time points, the reported figures were 9.2% for placebo, 5.2% for once-daily, and 3.9% for twice-daily. Several other planned secondary outcomes — including remission at week 52 alone, continuous remission, and clinical response — were not reported with numbers, with the trial record noting that the early termination of the study meant there was insufficient data to draw conclusions from those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01298492 · results posted 31 August 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 268 people, all of whom received a drug called PF-00547659 at a dose of 75 mg. The trial was a long-term safety study, meaning its main purpose was to track and record any unwanted health events (called adverse events) that participants experienced while taking the drug. By the time the study ended, 149 participants had completed it, while 119 did not finish for various reasons. The reported data shows that out of the 268 people who started, 249 experienced at least one adverse event (an unwanted health occurrence recorded during the study). Of those, 53 had an adverse event serious enough that they stopped taking the drug because of it. Additionally, 80 participants experienced what are classified as "serious adverse events" — meaning events that were life-threatening, required hospitalisation, caused lasting disability, or had other significant consequences. For one of the secondary measures, the reported data shows that 63 participants developed antibodies against the drug itself (meaning their immune system produced a response to the drug). The study also tracked the amount of drug present in participants' blood at various points over time; the reported figures ranged from around 6,670 to roughly 12,960 nanograms per millilitre (nanograms per millilitre is simply a way of measuring how much of a substance is in the blood). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02148718 · results posted 29 August 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT02148718) enrolled 86 people, all of whom received the medication adalimumab. The trial was set up to look at how participants with Crohn's disease responded to this treatment over time, using a scoring tool called the Harvey-Bradshaw Index (HBI) — a questionnaire that captures things like general wellbeing, abdominal pain, and the number of loose stools per day. Of the 86 people who started the trial, 55 completed it and 31 did not. The main thing the trial was measuring was the proportion of participants whose HBI score dropped by at least 3 points by Day 4 of treatment. The reported data shows that at Day 4, approximately 61.6% of participants had a drop of at least 3 points on the HBI score — this was the primary (main) measurement the trial was designed to capture. By Week 1, the reported figure rose to around 75.6% of participants meeting that same threshold. For a separate measure — remission, meaning an HBI score below 5 — the reported data shows approximately 54.7% of participants reached that point by Weeks 2 and 4 combined, rising to around 62.8% by Week 4 alone. The trial also tracked quality-of-life scores using two questionnaires over 12 weeks. On a general health scale (where 1 represents full health), participants' average score at the start was reported as 0.62, and the average change by Week 12 was reported as an increase of 0.14. On a separate self-rated health scale out of 100, the average starting score was reported as 55.4, with an average change of plus 15.4 points by Week 12. A bowel-disease-specific quality-of-life questionnaire (scored from 7 to 252, with higher being better) showed an average starting score of 145.1 and an average reported change of plus 44.7 points by Week 12. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01536418 · results posted 17 August 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 253 adults with moderately-to-severely active Crohn's disease — a chronic inflammatory bowel condition. Participants were split into two groups: 127 people received a drug called GSK1605786A at a dose of 500 mg once daily, and 126 received the same drug at 500 mg twice daily. The trial was primarily measuring whether participants' Crohn's disease symptoms improved noticeably by Week 12, using a scoring system called the CDAI (Crohn's Disease Activity Index), which rates disease severity based on things like bowel habits, abdominal pain, and general wellbeing. It is worth noting the trial was stopped early — the reported data states this was due to an absence of a favourable benefit-to-risk profile for the drug. The reported data shows that at Week 12, about 25% of participants in the once-daily group and about 33% in the twice-daily group showed a meaningful reduction in their CDAI score (a drop of 100 points or more), which the trial defined as a "clinical response." For the secondary measures, the reported data shows that at Week 12, approximately 12% of the once-daily group and 18% of the twice-daily group reached what the trial called "clinical remission" (a CDAI score below 150, indicating low disease activity). At the earlier Week 8 check, around 24% (once daily) and 29% (twice daily) showed a clinical response. Some additional measurements — including blood and stool markers of inflammation, and drug levels in the blood — were not collected because the trial was terminated early, so that data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01036022 · results posted 26 June 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01036022) enrolled 78 people in total across six groups. Fifteen people received a placebo (a dummy treatment with no active ingredient), sixteen received an existing medicine called Asacol, and the remaining 47 were split across four different dose levels of an investigational medicine called GSK1399686 (10 mg, 30 mg, 100 mg, and 300 mg — 11 to 12 people per dose group). Not everyone finished the study: across all groups, between 7 and 13 people per group completed it. The trial was primarily measuring a range of health monitoring information — including unwanted medical events, blood test results, urine tests, blood pressure, heart rate, and heart tracing (ECG) readings — rather than how well the treatment worked against a disease. The reported data shows that when it came to unwanted medical events (called adverse events), 10 out of 15 placebo participants, 7 out of 11 in the 10 mg group, 9 out of 12 in the 30 mg group, 6 out of 12 in the 100 mg group, 5 out of 12 in the 300 mg group, and 12 out of 16 in the Asacol group had at least one such event recorded. Serious adverse events (more significant medical occurrences) were reported for 1 person in the placebo group, 2 in the 10 mg group, and 1 in the Asacol group, with none reported in the three higher GSK1399686 dose groups. For blood chemistry results outside normal ranges, only small numbers of participants were flagged across groups (ranging from 0 to 1 per group depending on the measure). Similarly, for blood cell counts outside normal ranges, the numbers were small, ranging from 0 to 3 participants per group. Urine test abnormalities and vital sign readings outside defined ranges were also reported in only a small number of participants across the groups. For heart tracings (ECG), between 2 and 3 participants per group had some form of abnormal finding noted, with 1 to 2 per group having findings considered clinically significant. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01942720 · results posted 31 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people, all of whom had Crohn's disease and underwent a procedure called video capsule endoscopy — where a person swallows a small camera in a capsule that takes pictures as it travels through the digestive system. The trial was measuring whether scores from this capsule camera procedure could track changes in gut inflammation over six months, and whether those scores lined up with a doctor's overall assessment of disease activity as well as scores from a separate camera procedure (a traditional endoscopy of the lower small bowel). Of the 74 people who started, 53 completed the trial and 21 did not. The reported data shows that, on average, the doctor's overall disease rating (scored 0–3) changed by −0.3 points over six months, meaning it shifted slightly toward the lower end of that scale. Two different capsule-based scoring systems also showed average changes in the same direction: the Lewis Score (where lower numbers suggest less inflammation) changed by an average of −382.9 points, and the CECDEIS score (a separate capsule scoring system, also where lower means less inflammation) changed by an average of −2.7 points. For the traditional endoscopy comparison in the lower small bowel, the reported average scores at the start were 3.2 (traditional scope), 11,941.1 (Lewis Score), and 14 (CECDEIS); after six months those scores changed by −0.4, −410.8, and −3.1 respectively. The reported data also shows that 5 serious adverse events (unexpected medical problems) and 59 non-serious adverse events were recorded during the trial, along with 5 cases described separately; no capsule retention events (where the capsule gets stuck inside the body) were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01458574 · results posted 18 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 593 people with ulcerative colitis — a condition causing inflammation of the large bowel. Participants were split into three groups: 198 received a lower dose of tofacitinib (5 mg twice daily), 197 received a higher dose (10 mg twice daily), and 198 received a placebo (a dummy tablet with no active ingredient). The trial ran for 52 weeks and was mainly measuring how many people reached "remission" — meaning their disease activity score (called the Mayo score, a standard tool rated 0–12 where lower numbers mean less severe disease) dropped to a very low level by the end of the year. The reported data shows that, for the main goal of remission at week 52, 34.3% of participants in the lower-dose group and 40.6% in the higher-dose group met the remission criteria, compared with 11.1% in the placebo group. For the secondary measures, the reported figures at week 52 were: "mucosal healing" (meaning the bowel lining appeared less inflamed on camera examination) was seen in 37.4% (lower dose), 45.7% (higher dose), and 13.1% (placebo). Being in remission and off steroids at both the 6-month and 12-month check-ins — among those already in remission at the start — was reported for 35.4%, 47.3%, and 5.1% respectively across the three groups. The reported data also shows results at the halfway point (week 24): remission was recorded in 33.8% (lower dose), 35.5% (higher dose), and 11.1% (placebo); mucosal healing at week 24 was 43.9%, 46.2%, and 17.2%. Sustained remission at both week 24 and week 52 was reported in 22.2%, 25.4%, and 5.1% across the three groups. It is worth noting that more participants in the placebo group did not complete the study (145 out of 198) compared with the tofacitinib groups, which is common in maintenance trials of this design where participants who are not responding may leave early. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01393626 · results posted 28 April 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01393626) enrolled 279 people with Crohn's disease — a condition causing ongoing inflammation in the digestive tract. Participants were divided into four groups: 91 received a placebo (a dummy treatment with no active ingredient), 86 received tofacitinib at 5 mg twice daily, 86 received tofacitinib at 10 mg twice daily, and 16 received tofacitinib at 15 mg twice daily. The trial ran for 8 weeks and used a scoring system called the CDAI (Crohn's Disease Activity Index), which combines eight different measures of disease — such as bowel habits, pain, and general wellbeing — into a single number ranging from 0 to around 600, where a higher number means more severe disease. The main thing being measured was how many people in each group reached a CDAI score below 150 by week 8, which was defined in this trial as being in "remission" (very low disease activity). The 15 mg group was closed early due to low numbers, so formal results for that group were only reported for the CDAI score measure. The reported data shows that at week 8, approximately 36.7% of placebo participants, 43.5% of the 5 mg tofacitinib group, and 43.0% of the 10 mg tofacitinib group had a CDAI score below 150. For secondary measures, the trial also tracked how many people had a meaningful drop in their CDAI score — either a fall of at least 70 points or at least 100 points from where they started. By week 8, a drop of at least 70 points was reported in 62.2% of the placebo group, 76.5% of the 5 mg group, and 74.4% of the 10 mg group. A drop of at least 100 points by week 8 was reported in 54.4% of the placebo group, 70.6% of the 5 mg group, and 68.6% of the 10 mg group. The average CDAI scores at week 8 were reported as approximately 195 for the placebo group, 163 for the 5 mg group, 159 for the 10 mg group, and 172 for the 15 mg group (though that last figure should be interpreted with caution given the very small group size). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01620255 · results posted 27 March 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 357 adults across five groups to test different doses of an investigational medicine called PF-00547659 against a placebo (a dummy treatment with no active ingredient) in people with ulcerative colitis — a condition causing inflammation of the large bowel. The groups received either placebo or one of four doses: 7.5 mg, 22.5 mg, 75 mg, or 225 mg of PF-00547659. The main thing being measured was the proportion of participants who reached "clinical remission" (very low disease activity based on a standard scoring tool called the Mayo Score) at 12 weeks. A number of secondary things were also measured, including how many people showed a meaningful improvement in their symptoms (called "clinical response") and how many showed healing of the bowel lining (called "mucosal healing"). The reported data shows that, for the primary measure of clinical remission at 12 weeks, the following percentages of participants in each group met that definition: placebo 2.7%, 7.5 mg dose 11.3%, 22.5 mg dose 16.7%, 75 mg dose 15.5%, and 225 mg dose 5.7% (these figures are based on central review of bowel-lining scans, which was the main method of analysis). For clinical response at 12 weeks, the reported figures were: placebo 28.8%, 7.5 mg 38.0%, 22.5 mg 54.2%, 75 mg 45.1%, and 225 mg 50.0%. For mucosal healing at 12 weeks, the reported percentages were: placebo 8.2%, 7.5 mg 15.5%, 22.5 mg 27.8%, 75 mg 25.4%, and 225 mg 14.3%. The reported data also shows that the average change in the overall Mayo Score from the start of the trial to week 12 was −1.5 points for placebo, −2.4 for 7.5 mg, −2.9 for 22.5 mg, −2.5 for 75 mg, and −2.9 for 225 mg (where a negative number means a reduction in the score). One secondary outcome — relating to a partial Mayo Score measure at weeks 4, 8, and 12 — had no results data reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01345318 · results posted 20 March 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01345318) involved 191 participants who all received the study drug PF-04236921. The trial was measuring two main things: how many participants experienced unwanted medical events (called adverse events) while on treatment, including serious ones or those that led to stopping the treatment; and whether participants' bodies produced certain immune responses (proteins called anti-drug antibodies or neutralising antibodies) that can sometimes develop when a person receives a biological medicine. By the end of the study, 111 participants had completed it, while 80 did not complete it (the reasons for non-completion were not detailed in the reported data). The reported data shows that out of 191 participants who received the drug, 171 experienced at least one adverse event (an unwanted medical occurrence of any kind during treatment), 58 experienced a serious adverse event (meaning a more significant medical event such as hospitalisation or a life-threatening situation), and 54 stopped taking the study drug because of an adverse event. Regarding immune responses, the reported data shows that approximately 0.52% of participants developed anti-drug antibodies, and the same figure of 0.52% was reported for those who developed neutralising antibodies (a specific type that can potentially interfere with how a drug works in the body). It is worth noting that this trial did not include a separate comparison group, so all figures relate solely to participants who received PF-04236921. No data from a placebo or alternative treatment group was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01369355 · results posted 23 February 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01369355) looked at a medicine called ustekinumab as a maintenance (ongoing) treatment for people with Crohn's disease, a condition causing inflammation in the digestive tract. The main maintenance phase ran from Week 0 to Week 44, with a longer follow-up extension continuing to Week 272. In the main maintenance phase, the trial enrolled 1,281 participants across six groups, who either continued receiving ustekinumab (by injection under the skin, either every 8 or every 12 weeks) or received a placebo (an inactive dummy injection). The trial's main goal was to measure how many participants reached what researchers call "clinical remission" — meaning their disease activity score (called the CDAI score) dropped below 150 points, indicating low disease activity — by Week 44. The reported data shows that for the primary outcome — the number of participants in clinical remission at Week 44 — 47 out of 133 participants in the placebo group, 63 out of 132 in the ustekinumab every-12-weeks group, and 68 out of 132 in the ustekinumab every-8-weeks group reached that threshold. For the secondary outcomes, the reported data shows that clinical response (a meaningful drop in the CDAI score) at Week 44 was recorded in 58 placebo participants, 75 in the every-12-weeks group, and 76 in the every-8-weeks group. Among participants who were already in remission at the start of the maintenance phase, 36 (placebo), 44 (every-12-weeks), and 52 (every-8-weeks) remained in remission at Week 44. For remission without the use of corticosteroid (steroid) medicines, the numbers reported were 39, 55, and 60 respectively. In a smaller subgroup of participants who had previously not responded to, or could not tolerate, a different type of medicine called a TNF antagonist, the numbers in remission at Week 44 were 16 (placebo), 22 (every-12-weeks), and 23 (every-8-weeks). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01393899 · results posted 9 January 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01393899) enrolled 180 people with Crohn's disease — a condition causing ongoing inflammation in the digestive tract. Participants were divided into three groups: 59 received a placebo (a dummy treatment with no active ingredient), 60 received a lower dose of tofacitinib (5 mg twice daily), and 61 received a higher dose (10 mg twice daily). The trial ran for 26 weeks and was measuring how many people either showed a meaningful improvement in their disease activity score — using a standard tool called the Crohn's Disease Activity Index (CDAI), which rates symptoms on a scale from 0 to around 600 — or reached a point considered "remission" (a score below 150, meaning very low disease activity). It is worth noting that a notable number of participants did not complete the study: 32 in the placebo group, 28 in the lower-dose group, and 23 in the higher-dose group did not finish. The reported data shows that at the main 26-week check-in, the percentage of participants who had either improved their score by at least 100 points or were in remission was 38.1% in the placebo group, 39.5% in the lower-dose tofacitinib group, and 55.8% in the higher-dose tofacitinib group. For remission specifically at week 26, the reported figures were 31.0% (placebo), 32.6% (lower dose), and 39.5% (higher dose). The reported data also shows that for "sustained remission" — meaning participants were in remission at both the week 20 and week 26 check-ins — the figures were 21.4% (placebo), 23.3% (lower dose), and 39.5% (higher dose). Earlier time points (weeks 4, 8, 12, and 20) showed varying percentages across all three groups, with results shifting up and down over the course of the study across all groups including placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01369342 · results posted 6 January 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 640 adults with Crohn's disease — a condition causing ongoing inflammation of the digestive tract. Participants were randomly placed into one of three groups: 214 received a placebo (an inactive drip with no medicine), 213 received a fixed intravenous (drip) dose of ustekinumab at 130 mg, and 213 received a weight-based intravenous dose of ustekinumab at approximately 6 mg per kilogram of body weight. The main thing being measured was how many people showed a meaningful reduction in their Crohn's disease symptom score — using a standard scoring tool called the CDAI — by week 6. The reported data shows that at week 6, 60 out of 214 participants in the placebo group, 108 out of 213 in the 130 mg ustekinumab group, and 116 out of 213 in the weight-based ustekinumab group met the threshold for a meaningful reduction in their symptom score. For the secondary measures, the reported data shows that by week 8, 41 placebo participants, 64 in the 130 mg group, and 84 in the weight-based group had symptom scores low enough to be counted as being in "remission" (meaning their score fell below a set threshold indicating low disease activity). Also at week 8, 67, 99, and 121 participants respectively showed a meaningful symptom score reduction across the three groups. The reported data also shows additional secondary measures at weeks 3 and 6 looking at a smaller (70-point) reduction in the symptom score. At week 6, that threshold was reached by 81 placebo participants, 123 in the 130 mg group, and 135 in the weight-based group. At week 3, the numbers were 66, 103, and 106 respectively. No other outcome figures were included in the data submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01369329 · results posted 7 December 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01369329) enrolled 769 people with Crohn's disease — a condition that causes ongoing inflammation in the digestive tract. Participants were divided into three groups: 256 received a placebo (a dummy treatment with no active ingredient), 254 received a fixed dose of ustekinumab (130 mg), and 259 received a weight-based dose of ustekinumab (approximately 6 mg per kilogram of body weight). The trial was measuring how many people showed a meaningful reduction in their Crohn's disease symptom score — tracked using a tool called the Crohn's Disease Activity Index (CDAI), where a higher number means more severe symptoms — by week 6 of treatment. The reported data shows that at week 6, 53 out of 256 people in the placebo group, 84 out of 254 in the 130 mg ustekinumab group, and 84 out of 259 in the weight-based ustekinumab group reached the main target of a significant reduction in their symptom score. For the secondary measurements, the reported data shows that by week 8, the number of participants whose symptom score fell below 150 points (considered a "remission" threshold) was 18 in the placebo group, 39 in the 130 mg group, and 52 in the weight-based group. Also at week 8, those showing a meaningful symptom score reduction numbered 50 (placebo), 82 (130 mg), and 94 (weight-based). Earlier check-ins at week 3 and week 6 also recorded how many people had at least a 70-point drop in their symptom score, with the placebo group recording 67 and 75, the 130 mg group recording 94 and 113, and the weight-based group recording 101 and 109, at weeks 3 and 6 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01514240 · results posted 31 October 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 112 people with mild to moderately active Crohn's disease — a condition causing ongoing inflammation in the digestive tract. Participants were split into two groups of 56: one group received a treatment called D9421-C (9mg) alongside a dummy version of the comparison medicine, and the other group received mesalazine (3g) alongside a dummy version of D9421-C. The trial ran for 8 weeks and was primarily measuring how many people in each group reached "remission" — defined as scoring 150 or below on a standard Crohn's disease activity scale (the CDAI), where lower scores reflect less severe symptoms. The reported data shows that for the main outcome at 8 weeks, 17 out of 56 participants in the D9421-C group and 14 out of 56 in the mesalazine group met the remission threshold. For the additional (secondary) outcomes, at 2 weeks the reported remission numbers were 7 (D9421-C group) and 6 (mesalazine group), and at 4 weeks they were 12 and 7 respectively. The trial also tracked how much participants' CDAI scores changed from their starting point. The reported data shows average score reductions of −38.5 (D9421-C) and −15.7 (mesalazine) at 2 weeks, −58.7 and −28.7 at 4 weeks, and −67.0 and −45.7 at 8 weeks. In all cases, a negative number means the score went down from the starting point — that is, symptoms as measured by the scale were recorded as less severe over time in both groups. It is worth noting that 6 people in the D9421-C group and 11 in the mesalazine group did not complete the trial, which the reported data acknowledges. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01465763 · results posted 7 June 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 614 people with ulcerative colitis — a condition causing inflammation of the large bowel. Most participants (476) were assigned to receive tofacitinib at a dose of 10 mg twice daily, 16 received tofacitinib at 15 mg twice daily, and 122 received a placebo (a dummy tablet with no active ingredient). The trial was measuring how many people reached "remission" — meaning their disease activity score dropped to a very low level — after 8 weeks of treatment. Note that because the 15 mg group was very small (only 16 people), the reported outcome figures focus on the 10 mg and placebo groups only. The reported data shows the following at the 8-week mark. For the primary goal — remission as measured by a standard disease activity scoring tool called the Mayo score — 18.5% of people in the tofacitinib 10 mg group met that definition, compared with 8.2% in the placebo group. For secondary measurements: when looking at healing of the bowel lining as seen on a camera examination, 31.3% of the tofacitinib 10 mg group met that threshold versus 15.6% on placebo. A broader measure called "clinical response" (a meaningful drop in the overall disease score) was recorded in 59.9% of the tofacitinib 10 mg group compared with 32.8% on placebo. More narrowly defined remission categories — based on bowel camera findings only, or on symptom scores alone — showed figures ranging from 6.7% down to 11.8% in the tofacitinib group versus 1.6% to 5.7% in the placebo group, depending on the exact definition used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01458951 · results posted 1 June 2016

  According to the results reported on ClinicalTrials.gov, this trial looked at tofacitinib — a tablet taken twice daily — in people with ulcerative colitis, a condition causing inflammation of the large bowel. A total of 547 people started the study: 429 took tofacitinib at a dose of 10 mg twice daily, 6 took a higher 15 mg twice daily dose, and 112 took a placebo (a dummy tablet with no active medicine). The main question the trial was measuring was how many participants reached "remission" — meaning their disease activity score dropped to a very low level — after 8 weeks. Note that the 15 mg group was very small and its results were not reported separately in the outcome data below. The reported data shows that for the primary measure — remission at 8 weeks — 16.6% of participants in the 10 mg tofacitinib group met that definition, compared with 3.6% in the placebo group. For the secondary measures, also at 8 weeks: 55.0% of the tofacitinib group showed a "clinical response" (a meaningful drop in their disease score) versus 28.6% in the placebo group; 28.4% versus 11.6% showed "mucosal healing" (improved appearance of the bowel lining on camera); 16.8% versus 3.6% met the criteria for "clinical remission"; 10.7% versus 2.7% reached "symptomatic remission" (no bleeding and normal stool frequency); and 7.0% versus 1.8% achieved "endoscopic remission" (bowel lining appearing normal on camera). These figures describe the proportions of participants who met each pre-defined measurement at the 8-week mark as recorded in the trial. The reported data shows differences between the two groups across all measures, but this summary does not draw any conclusions about whether the treatment works or is suitable for any individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01757964 · results posted 25 May 2016

  According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called "bacteriotherapy" (sometimes known as stool transplantation) in children with two types of inflammatory bowel disease — Crohn's disease and ulcerative colitis. A total of 13 participants took part: 9 with Crohn's disease and 4 with ulcerative colitis. All 13 participants completed the study. The trial was measuring whether participants' symptoms improved within two weeks of receiving the treatment, using scoring tools designed specifically for children — the Pediatric Crohn's Disease Activity Index (PCDAI) and the Pediatric Ulcerative Colitis Activity Index (PUCAI). These are standardised questionnaires that give a number reflecting how active a person's disease is, with higher scores meaning more severe symptoms. The reported data shows that the primary outcome was whether a participant's score dropped by 10 or more points on these scales — a drop of this size was used as the marker of a "response" to the treatment. According to the results reported on ClinicalTrials.gov, 13 participants were counted in the results for this outcome measure. However, the data as submitted does not include a breakdown of how many of those 13 participants actually achieved a drop of 10 or more points in their scores — only the total group size of 13 is listed for this outcome, and a specific responder count was not separately reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01482884 · results posted 5 April 2016

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called tralokinumab compared to a placebo (a dummy treatment with no active ingredient) in people with ulcerative colitis, a condition causing inflammation in the large bowel. A total of 56 people were assigned to receive tralokinumab and 55 to receive the placebo. The main thing the trial was measuring was "clinical response" at 8 weeks — this means whether a person's overall disease score (called the Mayo score, a 0–12 scale where higher numbers mean more severe disease) had dropped by a meaningful amount, based on things like how often they needed the toilet and whether they had rectal bleeding. The reported data shows that at 8 weeks, 37.5% of people in the tralokinumab group and 32.7% in the placebo group met the definition of clinical response. For the secondary measures, the average Mayo score dropped by 2.41 points in the tralokinumab group and 1.92 points in the placebo group. When looking at gut lining healing (assessed by camera), 32.1% of the tralokinumab group and 20.0% of the placebo group showed improvement. For remission (a Mayo score of 2 or less with no single area scoring highly), 17.9% of the tralokinumab group and 5.5% of the placebo group met that threshold. A separate tissue sample score (the Modified Riley score, rated 0–5) changed by −0.49 in the tralokinumab group and −0.74 in the placebo group. The reported data also shows that scores on a shorter version of the Mayo scale (which left out the camera finding) were tracked at weeks 4, 8, 12, 16, 20, and 24. In the earlier weeks the tralokinumab group showed slightly larger reductions, but by weeks 16–24 the placebo group's scores had also fallen to a similar or slightly greater degree; the exact reasons for these patterns were not explained in the submitted results. Not everyone finished the trial — 13 people in the tralokinumab group and 18 in the placebo group did not complete it, though the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01364896 · results posted 9 March 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 46 adults who had inflammatory bowel disease (IBD) and were taking immunosuppressive medicines (drugs that reduce immune system activity). All 46 participants completed the study. The trial was looking at how common a virus called HPV (human papillomavirus) was in this group, and whether there were any abnormal cell changes in the anal area — the kind of changes that can sometimes be detected through swab tests and tissue samples. The reported data shows that out of 46 participants, 41 tested positive for HPV of any type in the anal area. Of those, 16 were found to have a single HPV type, while 25 had more than one type at the same time. Looking at specific HPV types, the most commonly detected among those who tested positive was HPV 16, found in 65.2% of HPV-positive participants, followed by HPV 11 and HPV 45, each detected in 23.9% of HPV-positive participants. When it came to cell changes detected by swab testing, 21 participants had some form of abnormal result, while 28 had a normal result. The reported data also shows that 33 of the 46 participants underwent at least one tissue biopsy (a small sample taken for closer examination), and of those who had biopsies, 28 were reported to have high-grade anal dysplasia — meaning notable abnormal cell changes detected in the tissue samples. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00552344 · results posted 21 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 402 people who were all receiving a medicine called certolizumab pegol. There was only one group — no comparison or placebo group. The trial ran for up to 272 weeks (just over five years), though only 87 of the 402 participants completed the full study period. The trial's main focus was on tracking adverse events (unexpected medical occurrences experienced by participants during the study) and serious adverse events (those involving hospitalisation, death, life-threatening situations, or significant disability, among other criteria). The reported data shows that 89.6% of participants experienced at least one adverse event at some point during the study, and 37.1% experienced at least one serious adverse event as defined above. For the secondary measures, at a visit around week 262 (roughly five years into the study), 11.6% of participants met the threshold for remission on the Harvey Bradshaw Index — a scoring tool that rates symptoms like general wellbeing, abdominal pain, and bowel movements, where a lower score indicates fewer symptoms. The reported data also shows that 7.8% of participants met remission criteria on a quality-of-life questionnaire (called the IBDQ) at that same visit. Regarding the medicine's levels in the blood, the average measured concentration after one year was 6.317 micrograms per millilitre, and 10.2% of participants were found to have developed antibodies (proteins the body can produce in response) to certolizumab pegol at some point across both this and a linked earlier study. It is worth noting that because there was no comparison group in this trial, the reported figures describe what was observed in participants receiving the medicine only, without a direct comparison to another treatment or placebo. The large proportion of participants who did not complete the study (315 out of 402) may be relevant context when considering these numbers, though the reasons for non-completion were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01287897 · results posted 21 January 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01287897) enrolled 250 adults with Crohn's disease across four groups: 70 received a placebo (dummy treatment), 69 received a 10 mg dose of the experimental drug PF-04236921, 71 received a 50 mg dose, and 40 received a 200 mg dose. The trial was measuring whether participants' Crohn's disease symptoms improved, using a scoring tool called the Crohn's Disease Activity Index (CDAI) — a questionnaire-based score that tracks symptoms over a week. The main thing being measured was whether a participant's CDAI score dropped by 70 points or more from their starting score (called a "CDAI-70 response"), checked at 8 weeks and again at 12 weeks. The reported data shows the following percentages of participants whose scores dropped by at least 70 points. At 8 weeks: 30.6% of the placebo group, 35.0% of the 10 mg group, and 49.3% of the 50 mg group showed this level of score reduction. In the separate comparison involving the 200 mg group, 28.8% of the placebo participants and 39.0% of the 200 mg participants showed this reduction at 8 weeks. At 12 weeks, the reported figures were 28.6% (placebo), 35.2% (10 mg), and 47.4% (50 mg); and in the 200 mg comparison, 26.7% (placebo) versus 41.7% (200 mg). The secondary outcomes tracked these same response rates at earlier time points across the weeks of the study, and the reported data shows the percentages in each group changing gradually over time in a similar pattern. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01562314 · results posted 14 August 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01562314) enrolled 60 people with ulcerative colitis — 29 who received a study drug called GWP42003 (a cannabidiol-based medicine) and 31 who received a placebo (a dummy treatment with no active ingredient). The trial's main goal was to measure how many participants reached a low disease activity score — called a Mayo score of 2 or less — by the end of treatment. The Mayo score is a tool doctors use to measure how active ulcerative colitis is, combining information about bowel habits, bleeding, results from a camera examination of the bowel, and the doctor's overall assessment of severity; a lower score means less active disease. The reported data shows that, among all participants who received at least one dose, 8 out of 29 people in the GWP42003 group and 8 out of 31 people in the placebo group reached that low Mayo score target by the end of treatment. In a smaller subgroup who more closely followed the study rules (the "per protocol" group), 7 out of 17 in the GWP42003 group and 8 out of 27 in the placebo group reached the target. For a secondary measure — the doctor's overall rating of disease severity on a 0–3 scale — the reported average score changed by roughly −0.8 points in the GWP42003 group and −0.4 points in the placebo group from the start to the end of treatment (a negative number meaning the score went down). The per-protocol analysis showed similar figures of −0.9 and −0.4 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01130844 · results posted 9 July 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 52 children and young people in total, divided into three groups based on their dose of a medication called MMX Mesalamine (also known as 5-ASA): 21 participants received 30 mg per kilogram of body weight, 22 received 60 mg per kilogram, and 9 received 100 mg per kilogram. All 52 participants who started the study completed it. The trial was primarily measuring how the drug moves through the body — specifically how much of it enters the bloodstream, how high the concentration gets, how quickly that peak is reached, and how fast the body clears it. A secondary measure looked at how much of the dose could be detected in urine. The reported data shows that the overall drug exposure in the blood (measured as "area under the curve," which is a way of capturing both how much drug was present and for how long) was 21,411 units in the lowest-dose group, 46,173 in the middle-dose group, and 49,213 in the highest-dose group. The peak blood concentration reached was reported as 1,884 units, 3,825 units, and 4,314 units for the three groups respectively. The time it took to reach that peak was reported as 6.0 hours, 8.98 hours, and 1.98 hours. The rate at which the body cleared the drug was 6.48, 5.94, and 4.95 litres per hour across the three groups. Similar exposure figures were also reported for the drug's main breakdown product in the body. The reported data shows that the proportion of the dose that was absorbed and detected in urine was 29.4% for the lowest-dose group, 27.0% for the middle-dose group, and 22.1% for the highest-dose group. No other secondary outcome figures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01453946 · results posted 19 June 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01453946) involved 50 participants who were given a treatment called Entocort (a type of steroid medication used in bowel conditions). The trial was designed for children with Crohn's disease — a condition that causes inflammation in the digestive tract. Of the 50 people who started, 41 completed the trial and 9 did not finish. The study was measuring adverse events (that is, any unwanted or unexpected health occurrences during the trial) as its main focus, alongside two secondary measures: disease activity using a scoring tool called the Pediatric Crohn's Disease Activity Index (PCDAI, scored from 0 meaning no disease activity to 100 meaning very high activity), and quality of life using a questionnaire called IMPACT-III designed for children with bowel disease. The reported data shows that out of 50 participants, 37 experienced at least one adverse event of any kind during the trial — this was the primary outcome being tracked. For the PCDAI disease activity score, the reported figures include values of 4.9, 2.0, and 6.9 (on the 0–100 scale), though the data as submitted does not clearly label which figure corresponds to which time point or measurement type, so these numbers cannot be described in further detail beyond what was reported. Similarly, for the IMPACT-III quality of life questionnaire, the reported values were 146.6, 1.2, and 147.0, but again the submission does not include enough labelling detail to explain what each individual figure represents, so only the numbers themselves can be noted here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00065065 · results posted 2 December 2014

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called rosiglitazone as a potential treatment for ulcerative colitis (UC), a condition causing inflammation of the large bowel. A total of 105 people took part — 52 received rosiglitazone and 53 received a placebo (a dummy treatment with no active ingredient). After 12 weeks, 42 people in the rosiglitazone group and 33 in the placebo group had completed the study, with 10 and 20 people respectively not finishing. The reported data shows that the main thing being measured was how many participants showed an improvement in their UC signs and symptoms at 12 weeks, based on a standard scoring tool called the Mayo score (a higher score means more severe disease). According to the results, 23 out of 52 people in the rosiglitazone group showed this improvement, compared to 12 out of 53 in the placebo group. For one of the secondary measures — the number of people whose UC went into full clinical remission (meaning their Mayo score dropped to 2 or below, indicating very mild or no active disease) — the reported figures were 9 out of 52 in the rosiglitazone group versus 1 out of 53 in the placebo group. The reported data also shows a second secondary measure: the number of people whose bowel lining, as seen via a camera examination, showed remission at 12 weeks. Here, 4 out of 52 people in the rosiglitazone group met this measure, compared to 1 out of 53 in the placebo group. No other outcome figures were included in the data submitted to ClinicalTrials.gov, so no further numbers can be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01190839 · results posted 22 October 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01190839) enrolled 297 people with Crohn's disease — 150 in the placebo group and 147 in the infliximab 5 mg/kg group — who had recently had bowel surgery. The trial was measuring whether Crohn's disease came back (called "clinical recurrence") over roughly 76 weeks (about 18 months) and 104 weeks (about 2 years), as well as whether signs of the disease returned when the bowel was examined with a camera (called "endoscopic recurrence"). It is worth noting that the reported data shows zero participants were recorded as having completed the study, and all participants were listed as "not completed," though the outcome results were still reported. The reported data shows that by around 76 weeks, 20.0% of participants in the placebo group and 12.9% in the infliximab group were recorded as having a clinical recurrence of Crohn's disease. When the bowel was examined by camera at or before 76 weeks, 60.0% of the placebo group and 30.6% of the infliximab group were recorded as having signs of the disease returning. By around 104 weeks (two years), the reported clinical recurrence figures were 25.3% in the placebo group and 17.7% in the infliximab group. These numbers describe what was recorded and counted during the trial; they do not tell us about individual experiences, and the reported data does not include further detail on how the results were analysed statistically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01576120 · results posted 9 October 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people diagnosed with Crohn's disease. All 40 participants completed the study — 21 were in one group and 19 in the other. The trial was looking at a bowel preparation (cleansing) regimen used before a PillCam COLON 2 procedure, which is a type of capsule endoscopy where a person swallows a small camera capsule to view the inside of the bowel. The two groups differed in the order and amount of a "boost" drink given as part of the bowel prep: one group received a larger 6-ounce boost first followed by a smaller 3-ounce boost, while the other received the 3-ounce boost first followed by the 6-ounce boost. The reported data shows that the primary outcome measured was the level of bowel cleansing achieved — that is, how well the preparation cleared the bowel before the capsule camera procedure. According to the results reported on ClinicalTrials.gov, 62% of participants in the group that received the larger boost first achieved a satisfactory cleansing level, compared with 79% of participants in the group that received the smaller boost first and the larger boost second. No other outcome measures appear to have been reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00679380 · results posted 1 August 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 410 adults with ulcerative colitis (a condition causing inflammation of the large bowel). Participants were divided into four groups: one group took a lower dose (6 mg) of a medication called Budesonide-MMX®, another took a higher dose (9 mg) of the same medication, a third group took a different budesonide product called Entocort EC® (3 mg), and the fourth group took a placebo (a dummy pill with no active ingredient). The trial ran for 8 weeks and was primarily measuring how many people reached full remission — meaning their bowel disease showed little to no activity on both symptom scores and a camera examination of the bowel lining. The reported data shows that for the main outcome — reaching full remission — 8.3% of the Budesonide-MMX® 6 mg group, 17.4% of the Budesonide-MMX® 9 mg group, 12.6% of the Entocort EC® group, and 4.5% of the placebo group met that definition. For the first secondary outcome — meaningful symptom improvement (a notable drop in the disease activity score) — the reported figures were 25.7% for the 6 mg group, 42.2% for the 9 mg group, 33.0% for the Entocort EC® group, and 33.7% for the placebo group. For the second secondary outcome — improvement seen on the bowel camera examination — the reported percentages were 25.7%, 42.2%, 36.9%, and 31.5% respectively. The trial notes that because the symptom improvement result did not reach formal statistical significance (meaning the difference between groups could not be ruled out as being due to chance), no further formal comparisons were made for the camera examination outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00783692 · results posted 21 July 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00783692) looked at a medication called vedolizumab in people with Crohn's disease, a condition that causes ongoing inflammation in the digestive tract. The trial ran in two back-to-back stages. In the first stage (the "induction phase"), 148 participants received a placebo (a dummy treatment) and 220 received vedolizumab, with a further 748 receiving vedolizumab in an open-label arm (meaning everyone knew what they were getting). In the second stage (the "maintenance phase"), participants were divided into groups receiving placebo, vedolizumab every eight weeks, vedolizumab every four weeks, or a non-responder group. The trial measured things like whether participants reached "clinical remission" — meaning their Crohn's disease symptom score dropped to a low level — and whether their symptoms improved meaningfully compared to the start of the trial. The reported data shows that at six weeks (end of the induction phase), 6.8% of placebo participants and 14.5% of vedolizumab participants had reached clinical remission. When looking at a broader measure of improvement (a symptom score dropping by at least 100 points), 25.7% of the placebo group and 31.4% of the vedolizumab group met that threshold. A blood marker of inflammation called C-reactive protein (CRP) changed by an average of −0.5 mg/L in the placebo group and −0.9 mg/L in the vedolizumab group over those six weeks. At week 52 (end of the maintenance phase), the reported remission rates were 21.6% for placebo, 39.0% for vedolizumab given every eight weeks, and 36.4% for vedolizumab given every four weeks. For the broader improvement measure at week 52, the figures were 30.1% (placebo), 43.5% (every eight weeks), and 45.5% (every four weeks). Among participants who had been using steroid medications at the start, the percentage who had stopped steroids and were also in remission at week 52 was reported as 15.9% for placebo, 31.7% for vedolizumab every eight weeks, and 28.8% for vedolizumab every four weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01177228 · results posted 18 July 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people in total across four groups: 9 received a placebo (an inactive substance), and the remaining 38 received one of three different doses of a medicine called vedolizumab — either 2 mg/kg, 6 mg/kg, or 10 mg/kg of body weight. The trial was primarily measuring how the drug moved through the body at different doses (for example, how quickly it was absorbed and how long it stayed in the bloodstream), as well as tracking any unwanted medical events that occurred during the study. Most participants completed the trial — only three people across all groups did not finish. The reported data shows that higher doses of vedolizumab were associated with higher levels of the drug detected in the blood. For example, the peak blood concentration on the first day of dosing was reported as 54.0 µg/mL for the lowest dose group, 154.3 µg/mL for the middle dose group, and 279.0 µg/mL for the highest dose group. The time it took for the drug level to fall by half ranged from about 15 to 22 days depending on the dose. The reported data also shows a measure of how much the drug appeared to attach to its target (a receptor on certain immune cells): across all three vedolizumab dose groups, this attachment was reported at around 98–100%, compared to roughly 18–57% in the placebo group at various time points. Regarding unwanted medical events, 7 out of 9 placebo participants, 9 out of 12 in the lowest dose group, 9 out of 14 in the middle dose group, and 6 out of 11 in the highest dose group were reported to have experienced at least one adverse event. Serious adverse events (those involving hospitalisation or significant harm) were reported for 1 participant in the 6 mg/kg group and 1 in the 10 mg/kg group; none were reported in the placebo or lowest dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00487539 · results posted 17 February 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,065 people in total across four groups: one group received a placebo (a dummy treatment with no active ingredient), and three groups received different doses of a medicine called golimumab. All participants had ulcerative colitis, a condition causing inflammation in the large bowel. The trial was primarily measuring how many people showed a meaningful improvement in their symptoms — called a "clinical response" — after six weeks, using a standard scoring system (the Mayo score) that rates bowel symptoms, bleeding, and other signs of disease on a scale from 0 to 12, where higher numbers mean more severe disease. The reported data shows that at six weeks, 76 out of 331 placebo participants showed a clinical response, compared with 129 out of 331 in the medium-dose golimumab group and 141 out of 331 in the higher-dose golimumab group. For the secondary outcomes, the number of participants whose disease reached a low-symptom state (called "remission," a Mayo score of 2 or below) was 16 in the placebo group, 45 in the medium-dose group, and 46 in the higher-dose group. The number showing healing of the bowel lining on camera (called "mucosal healing") was 72, 107, and 116 in the placebo, medium-dose, and higher-dose groups respectively. A quality-of-life questionnaire (scored from 32 to 224, with higher being better) showed that participants in all three groups started at similar scores (around 127–132), and the reported improvement from that starting point was roughly 15 points for the placebo group, compared with approximately 27 points in each of the two golimumab groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00899678 · results posted 21 November 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 99 children and young people with Crohn's disease across three groups. Twenty-seven participants entered an initial six-week "induction" period where they were not assigned to ongoing treatment (only 2 of these completed that phase). The remaining 72 participants were randomly assigned to one of two maintenance groups — 37 received a lower dose and 35 received a higher dose — and were followed for roughly 62 weeks (about 14 months). The trial was measuring disease activity using a scoring tool called the Pediatric Crohn's Disease Activity Index (PCDAI), where a score of 0–100 is possible and a lower score means less disease activity. The reported data shows that at week 62, 24.3% of participants in the low-dose maintenance group and 17.1% in the high-dose maintenance group met the definition of "clinical remission" (a PCDAI score of 10 or below). When looking at "clinical response" — defined as the score dropping by at least 15 points and sitting at 30 or below — 29.7% of the low-dose group and 20.0% of the high-dose group met that threshold. The reported average PCDAI scores at week 62 were 8.18 for the low-dose group and 7.14 for the high-dose group, compared to starting scores that were roughly 38 and 34 respectively (reflecting reported average drops of about 29.8 and 27.1 points). A blood marker of inflammation called C-Reactive Protein (CRP) was also measured; at week 62 the low-dose group averaged 7.2 mg/L and the high-dose group averaged 5.8 mg/L. It is also worth noting that a large proportion of participants in both maintenance groups did not complete the full maintenance period — 25 out of 37 in the low-dose group and 28 out of 35 in the high-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00488631 · results posted 11 November 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,228 participants across six groups in its main double-blind phase (running from week 0 to week 54), with a further 666 participants entering a longer open-label extension phase that ran through to week 228 (roughly four years). The trial was looking at golimumab, an injectable medicine, as a maintenance treatment for people with ulcerative colitis who had already responded to an initial (induction) course of treatment. The main thing the trial set out to measure was how many participants who had responded to golimumab induction stayed in "clinical response" — meaning their overall disease score dropped meaningfully and rectal bleeding improved — all the way through to week 54. Disease activity was tracked using a scoring tool called the Mayo score, which adds up four measures of symptom severity on a scale of 0 to 12, with higher numbers meaning more severe disease. The reported data shows that, among participants who had responded to golimumab induction, 48 out of 156 in the placebo maintenance group maintained clinical response through week 54, compared with 71 out of 154 in the golimumab 50 mg maintenance group and 75 out of 154 in the golimumab 100 mg maintenance group. For the secondary outcomes, the reported data shows that the number of participants in clinical remission (a Mayo score of 2 or below with no single measure above 1) at both week 30 and week 54 was 24 (placebo), 35 (50 mg), and 42 (100 mg). The number with mucosal healing — meaning the lining of the bowel looked normal or near-normal on camera examination — at both week 30 and week 54 was 41 (placebo), 63 (50 mg), and 64 (100 mg). Among those who were already in remission at the start of the maintenance phase, remission at both week 30 and week 54 was reported in 13, 19, and 21 participants respectively. Among those taking corticosteroids at the start of the maintenance phase, the number who were in remission at week 54 while no longer on corticosteroids was reported as 16, 22, and 19 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00160524 · results posted 10 October 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT00160524) enrolled 595 participants, all of whom received the study drug certolizumab pegol. The trial ran for up to 84 months (seven years) and was an open-label extension study, meaning it followed on from two earlier trials. Of the 595 people who started, 117 completed the study and 478 did not complete it for various reasons. The study was primarily measuring how many participants experienced unwanted medical events (called adverse events) over the course of the trial. It also tracked things like participants' bowel disease symptoms using a scoring tool called the Harvey Bradshaw Index (HBI), which rates factors like general wellbeing, abdominal pain, and the number of loose stools per day — with lower scores indicating better wellbeing. The reported data shows that 88.2% of participants experienced at least one adverse event (any untoward medical occurrence) during the study, and 40.3% experienced at least one serious adverse event — defined as events such as death, a life-threatening situation, hospitalisation, or significant lasting disability. Regarding the secondary outcomes, 54.7% of participants had an HBI score of 4 or below (indicating remission, or low symptom burden on that scale) at their final visit, while 21.7% showed a response, meaning their HBI score dropped by 3 or more points from the start of the earlier feeder studies. The reported data also shows that 22.6% of participants developed antibodies to certolizumab pegol at some point during the combined study period, and the average measured level of the drug in participants' blood at their final visit was 5.578 micrograms per millilitre (a measure of how much of the drug was present in the bloodstream). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00160706 · results posted 4 July 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT00160706) enrolled 310 people, all of whom received the study medicine, certolizumab pegol. It was a long-term follow-on study running for up to 84 months (seven years). Participants had previously taken part in one of two earlier related trials. Of the 310 who started, only 24 completed the full study period, while 286 did not complete it — though the data does not detail all the reasons for this. The trial's main focus was tracking how many participants experienced unwanted medical events (called adverse events) over the course of the study, and it also looked at measures of how participants' bowel condition was tracking using a symptom scoring tool called the Harvey Bradshaw Index (HBI) — a score based on things like general wellbeing, abdominal pain, and number of loose stools per day, where lower scores indicate fewer symptoms. The reported data shows that 94.2% of participants experienced at least one adverse event (any unwanted medical occurrence) during the study, and 44.5% experienced at least one serious adverse event — meaning a medical event serious enough to involve hospitalisation, be life-threatening, or result in significant disability, among other criteria. These figures were the primary things the study set out to measure and record; the trial was not designed to prove the medicine does or does not cause these events, only to count and document them over the long term. For the secondary measures, the reported data shows that at the time participants either completed or left the study, 34.6% had an HBI score of 4 or below (which the study defined as "remission," meaning low symptom levels on that scale). When looking at whether participants' HBI scores had improved by 3 or more points compared to when they first entered the earlier feeder trials, 52.8% met that threshold; when compared to where they stood at the start of this particular study, 65.6% met that threshold. The reported average level of certolizumab pegol measured in participants' blood at their final visit was 5.870 micrograms per millilitre (a measure of how much medicine was present in the bloodstream). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00488774 · results posted 14 June 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 291 adults across four groups to study the drug golimumab (given by intravenous drip at three different doses — 1 mg, 2 mg, or 4 mg per kilogram of body weight) compared to a placebo (an inactive dummy treatment) in people with ulcerative colitis. The trial used a scoring system called the Mayo score, which combines four measures of disease severity — bowel movement frequency, rectal bleeding, results from a camera examination of the bowel, and a doctor's overall assessment — into a total score ranging from 0 (no disease activity) to 12 (most severe). The main thing the trial measured was how many participants had a meaningful improvement in their Mayo score, which the researchers called a "clinical response." The reported data shows that out of 77 placebo participants, 22 met this response measure. In the golimumab groups, the numbers were: 22 out of 62 in the 1 mg/kg group, 33 out of 75 in the 2 mg/kg group, and 32 out of 77 in the 4 mg/kg group. The trial also measured how many participants reached "clinical remission" — meaning their Mayo score dropped to 2 or below with no single sub-score above 1, indicating very low disease activity. The reported data shows that 8 out of 77 placebo participants reached remission, compared with 6 out of 62 in the 1 mg/kg group, 12 out of 75 in the 2 mg/kg group, and 10 out of 77 in the 4 mg/kg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00609973 · results posted 3 May 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people in total — 17 received the antibiotic ciprofloxacin ("Cipro") and 16 received a placebo (a dummy treatment with no active ingredient). The trial was looking at how ciprofloxacin was tolerated by participants after bowel surgery, and also at whether signs of disease could be seen on a camera examination of the bowel (endoscopy) at six months. Not everyone finished the study: 9 people in the Cipro group and 10 in the placebo group completed it. The reported data shows that for the primary focus — tracking unwanted side effects (called adverse events) — the Cipro group recorded 25 adverse events in total, compared with 11 in the placebo group. Within those numbers, 9 adverse events in the Cipro group and 1 in the placebo group were recorded as probably related to the study drug. Additionally, 4 people in the Cipro group and 1 person in the placebo group stopped taking the study medication because of an adverse event thought to be probably related to it. For the secondary measurement — signs of disease visible on the bowel camera at six months — the reported data shows 11 participants in the Cipro group and 11 participants in the placebo group had such findings recorded. It is worth noting that the data as submitted does not break down all adverse event figures in full detail, so some additional context may not be available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00984568 · results posted 2 April 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT00984568) enrolled 28 people in total — 15 in a group called "Top-Hold" and 13 in a group called "Step-Up." These appear to be two different approaches to treating ulcerative colitis (a condition causing inflammation of the large bowel). The trial was measuring whether participants responded to treatment early on (within 4 weeks) and whether they were in remission — meaning their disease was at a low, stable level — without using steroids, nearly a year later (at week 50). A scoring tool called the Mayo score was used throughout, where lower numbers indicate a better condition. It is worth noting that of the 28 people who started, only 14 completed the trial — 7 from each group. The reported data shows that for the primary outcome — responding to treatment at week 4 and being steroid-free and in remission at week 50 — 5 out of 15 participants in the Top-Hold group and 5 out of 13 participants in the Step-Up group met both of these conditions. For the secondary outcome, which looked at how many participants showed a meaningful improvement in their Mayo score within the first 4 weeks, the reported data shows 10 participants in the Top-Hold group and 10 participants in the Step-Up group achieved this. It is important to note that this was a relatively small trial, and a sizeable number of participants did not complete it, which the reported data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00805766 · results posted 5 December 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people with Crohn's disease — a condition that causes inflammation in the digestive tract. All participants received a treatment called TA-650 (a type of medication given by infusion). The trial had two stages: a screening period and an "increased dose period." Of the 45 who started the screening stage, 39 moved into the increased dose stage, and 26 completed that second stage. The trial was primarily measuring changes in a scoring system called the Crohn's Disease Activity Index (CDAI), which is a tool that rates disease symptoms on a scale roughly from 0 to 600 — where lower scores indicate fewer symptoms, and a score below 150 is considered "clinical remission" (meaning very low disease activity). The reported data shows that the main thing being tracked — the median change in CDAI score from the start to week 8 of the increased dose period — was a decrease of 95 points (in this trial, a decrease in symptoms was recorded as a positive number). The trial was aiming to confirm a decrease of at least 50 points, so the reported figure exceeded that target. The reported data also shows CDAI scores measured at various points during the increased dose period, ranging from around 105 to 297, and the proportion of participants whose scores fell into the "clinical remission" range (below 150) varied across time points, with figures reported between approximately 28% and 70% at different check-ins. The blood levels of TA-650 were also measured at multiple time points and fluctuated considerably across the study period. Additionally, the reported data shows that antibodies to TA-650 — proteins the body can sometimes produce in response to a treatment — were detected in approximately 23% of participants during the screening period and around 18% during the increased dose period, with the majority of participants (around 72–77%) showing no detectable antibodies at those time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00771667 · results posted 27 July 2012

  According to the results reported on ClinicalTrials.gov, this trial looked at ustekinumab as a treatment for Crohn's disease — a condition causing ongoing inflammation in the digestive tract. The trial ran in two phases. In the first phase (the "induction phase"), 526 people took part and were split into four groups: one group received a dummy treatment (placebo), and the other three groups received different doses of ustekinumab given by intravenous drip (directly into the vein). The trial used a scoring tool called the Crohn's Disease Activity Index (CDAI), which runs from 0 (very little disease activity) to over 600 (very severe), to measure whether participants' symptoms improved. The main thing the trial was measuring was how many people showed a meaningful drop in their CDAI score — called a "clinical response" — by week 6. The reported data shows that at week 6, out of 132 people in the placebo group, 31 met the criteria for clinical response. In the three ustekinumab dose groups (131, 132, and 131 people respectively), the numbers were 48, 45, and 52. For "clinical remission" — meaning symptoms dropped to a very low level (a CDAI score below 150) — at week 6, the reported figures were 14 in the placebo group and 21, 21, and 16 across the three ustekinumab groups. At week 8, clinical response numbers were 23 (placebo), 42, 42, and 57 (ustekinumab groups), and remission numbers were 14, 23, 24, and 24 respectively. People who responded by week 6 then moved into a second "maintenance phase," where some continued on ustekinumab injections under the skin and others received placebo injections. Among those responders, at week 22, the reported data shows 20 out of those on placebo injections were in remission, compared with 30 out of those receiving ustekinumab injections under the skin. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01004185 · results posted 25 May 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT01004185) enrolled 39 children and young people across two groups — 19 in a higher-dose group and 20 in a lower-dose group. The trial was measuring disease activity in paediatric ulcerative colitis (a condition causing inflammation of the large bowel) using a scoring tool called the PUCAI (Pediatric Ulcerative Colitis Activity Index). This tool scores symptoms such as abdominal pain, rectal bleeding, stool consistency, number of bowel movements, night-time symptoms, and activity levels, with a score under 10 considered "remission" — meaning very low disease activity. The main goal of the trial was to measure what percentage of participants in each group reached that remission threshold, which was called "treatment success." The reported data shows that, for the primary outcome, 53.3% of participants in the high-dose group and 60% of participants in the low-dose group reached the remission threshold. It is worth noting that of the 39 people who started the trial, only 10 in the high-dose group and 11 in the low-dose group completed it — meaning roughly half of participants in each group did not finish. The trial also reported a secondary outcome using a slightly different version of the PUCAI scoring system (with a more detailed five-point scale for abdominal pain instead of a three-point scale). Under that adjusted scoring method, the reported data shows that 60% of participants in both the high-dose and low-dose groups reached the remission threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00713310 · results posted 4 April 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 83 children and young people in total — 41 in a low-dose group and 42 in a high-dose group. The trial was measuring responses to two different doses of a treatment for a bowel condition called ulcerative colitis in children. It used a scoring tool called the PUCAI (Pediatric Ulcerative Colitis Activity Index), which rates symptoms such as abdominal pain, bleeding, stool consistency, how often a child needs the toilet, night-time toilet trips, and how much the condition limits daily activity. A lower score means fewer symptoms. The trial defined "treatment success" as either a very low score (under 10, meaning close to no symptoms) or a meaningful drop in the score by week 6. The reported data shows that, using the main scoring method, around 56% of participants in the low-dose group and 55% in the high-dose group met the definition of treatment success at week 6. A secondary analysis used a slightly different way of scoring abdominal pain (breaking it into more steps), and the reported figures were very similar — approximately 56% for the low-dose group and 58% for the high-dose group. In both analyses, the proportions in each group were close to each other. By the end of the study, 36 participants in each group had completed the trial; 5 in the low-dose group and 6 in the high-dose group did not complete it, though the reasons were not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00336492 · results posted 10 August 2011

  According to the results reported on ClinicalTrials.gov, this trial looked at the use of infliximab (a medicine given through a drip) in children and young people with ulcerative colitis, a condition causing inflammation in the large bowel. A total of 60 participants were enrolled across three groups: 15 in a "not randomised" group, 22 who received infliximab every 8 weeks, and 23 who received it every 12 weeks. The trial measured how participants' symptoms changed over time using two scoring tools — the Mayo score (which rates ulcerative colitis symptoms on a scale of 0 to 12, where higher means more disease activity) and the Pediatric Ulcerative Colitis Activity Index, or PUCAI (rated 0 to 85, again with higher meaning more activity). The reported data shows that for the main (primary) outcome — the number of participants showing a meaningful improvement in their Mayo score by week 8 — 44 participants across the infliximab groups met the criteria for what the trial called a "clinical response." For the secondary outcome measured at week 54, the reported data shows that 8 out of 22 participants in the every-8-weeks group, and 4 out of 23 in the every-12-weeks group, had PUCAI scores below 10, which the trial defined as remission (meaning very low disease activity based on that score). It is worth noting that by the end of the study, 4 participants in the every-8-weeks group and 11 in the every-12-weeks group did not complete the trial, and the reasons for not completing were not broken down further in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00505778 · results posted 12 May 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,027 people in total (514 in the once-daily group and 513 in the twice-daily group). The trial was comparing two different dosing schedules of a medicine called mesalamine — taking it once a day versus twice a day — in people with ulcerative colitis (a bowel condition) who were already in remission, meaning their symptoms were under control. The main thing the trial was measuring was how many participants stayed in remission after six months, using a symptom scoring tool called the Simple Clinical Colitis Activity Index (SCCAI), where a score below 5 was counted as remission. The reported data shows that at the six-month mark, 90.5% of participants in the once-daily group and 91.8% in the twice-daily group were recorded as remaining in remission according to the SCCAI score. At three months, those figures were 94.8% and 95.6% respectively, and at twelve months both groups recorded the same percentage — 85.4% — still in remission. The reported data also shows that 45 participants in the once-daily group and 39 in the twice-daily group had a flare-up (a return of symptoms) within six months. When participants were asked whether they personally felt their condition was in remission at six months, 83.1% of the once-daily group and 86.6% of the twice-daily group said yes. A questionnaire measuring how closely participants followed their medication routine (scored from 9 to 45, with 45 meaning perfect adherence) returned average scores of 42.3 for the once-daily group and 41.8 for the twice-daily group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00408629 · results posted 31 March 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 518 people in total — 258 received adalimumab (at a starting dose of 160 mg, then 80 mg, then 40 mg) and 260 received a placebo (an inactive dummy treatment). The trial was measuring whether adalimumab could bring about "clinical remission" in people with ulcerative colitis — meaning their disease activity score (called the Mayo score, a scale from 0 to 12 where lower numbers indicate less active disease) dropped to a low level at two time points: 8 weeks and 52 weeks into the study. By the end of the study, 161 people in the adalimumab group and 135 in the placebo group had completed it. The reported data shows that at 8 weeks, 16.5% of participants in the adalimumab group met the definition of clinical remission, compared with 9.3% in the placebo group. At 52 weeks, those figures were 17.3% in the adalimumab group and 8.5% in the placebo group. For a secondary measure — being in remission at both time points — the reported data shows 8.5% in the adalimumab group and 4.1% in the placebo group. The trial also measured "clinical response" (a meaningful improvement in score without necessarily reaching remission): at 8 weeks this was reported as 50.4% (adalimumab) versus 34.6% (placebo), and at 52 weeks 30.2% versus 18.3%. Sustained clinical response at both time points was reported as 23.8% versus 12.2%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00552058 · results posted 30 December 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 439 people with Crohn's disease — a chronic inflammatory bowel condition. Of these, 223 received a medicine called certolizumab pegol and 216 received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether certolizumab pegol could bring Crohn's disease symptoms down to a low level (called "clinical remission") by week 6, as judged by a standard symptom scoring tool called the Crohn's Disease Activity Index (CDAI), where a score of 150 or below counts as remission. Most participants completed the study — 207 in the medicine group and 192 in the placebo group. The reported data shows that at week 6, 31.6% of people in the certolizumab pegol group had reached clinical remission, compared with 25.4% in the placebo group. For the secondary measures, 40.5% of the medicine group showed a meaningful reduction in their symptom score (at least a 100-point drop) versus 34.0% in the placebo group. On a quality-of-life questionnaire specific to bowel disease, 36.7% of the medicine group reached the remission threshold compared with 28.7% in the placebo group. The reported data also shows that the average CDAI symptom score fell by 96.7 points in the medicine group and 73.1 points in the placebo group from the start of the trial to week 6. At the earlier two-week check, 23.3% of the medicine group and 15.8% of the placebo group had reached remission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00410410 · results posted 2 December 2010

  According to the results reported on ClinicalTrials.gov, this trial tested a medicine called abatacept in people with ulcerative colitis. The trial ran in three phases: an Induction Period (where participants were randomly assigned to different doses of abatacept or a placebo), a Maintenance Period, and an Open-Label Period (where everyone received abatacept). In the main induction phase (called Cohort 1), 141 people received a higher starting dose of abatacept, 139 received a standard dose, 70 received a lower dose, and 140 received a placebo. A further 101 people took part in a second induction cohort, and 349 entered the open-label phase. The trial used a scoring system called the Mayo Score (ranging from 0–12, where higher numbers mean more severe disease) to measure how participants' condition changed over 12 weeks. The reported data shows the following numbers for the primary outcome — the number of people who achieved a "clinical response" (meaning their Mayo Score dropped by at least 3 points and at least 30% from their starting score) by Week 12 in Cohort 1: 30 out of 141 in the higher-dose abatacept group, 26 out of 139 in the standard-dose group, 14 out of 70 in the lower-dose group, and 41 out of 140 in the placebo group. For the secondary outcomes, the reported data shows that the number of participants reaching "clinical remission" (a Mayo Score of 2 or below) at Week 12 was 3, 6, 4, and 15 respectively across those same groups. The number showing "mucosal healing" (improvement in the gut lining on examination) was 24, 20, 11, and 36. Starting Mayo Scores were similar across all groups, averaging around 8.6–8.9 out of 12, and starting quality-of-life scores (on a scale of 32–224, where higher is better) ranged from approximately 120 to 127 across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00151892 · results posted 21 September 2010

  According to the results reported on ClinicalTrials.gov, this trial compared two treatments for ulcerative colitis (a condition causing inflammation of the large bowel): SPD476 and Asacol. A total of 416 people were assigned to the SPD476 group and 413 to the Asacol group, making 829 participants in all. The main thing the trial was measuring was whether participants' bowel lining appeared to have settled down (called "endoscopic remission") after six months, as seen through a camera examination of the bowel. A number of secondary things were also measured, including whether people dropped out because their condition flared up, their overall symptom scores, and their quality of life. The reported data shows that, at six months, 83.7% of people in the SPD476 group and 81.5% in the Asacol group had bowel lining scores that met the definition of remission. When symptoms were also taken into account alongside the camera findings, 79.0% of the SPD476 group and 75.6% of the Asacol group met that combined measure. The reported data shows that 12.8% of the SPD476 group and 14.6% of the Asacol group left the study early because their condition worsened. For the overall disease activity score (where a lower score means less disease activity), both groups had very similar results. Quality of life was measured on a scale of 10 to 70 (higher meaning better), and the reported scores were 59.5 for the SPD476 group and 59.7 for the Asacol group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00406653 · results posted 31 August 2010

  According to the results reported on ClinicalTrials.gov, this trial (NCT00406653) tested a medicine called abatacept in people with Crohn's disease, an inflammatory bowel condition. The trial ran in three stages: an induction period (short-term treatment phase), a maintenance period (longer-term phase), and an open-label extension (where all remaining participants received abatacept). In the induction period, 451 people were enrolled across four groups — three receiving different doses of abatacept and one receiving a placebo (a dummy treatment with no active ingredient). In the maintenance period, 90 participants continued into two groups (abatacept or placebo). In the open-label extension, 324 participants started, though none had completed it at the time the data was submitted. The reported data shows the following numbers for the main outcomes measured. For the induction period, the trial tracked how many participants achieved a meaningful reduction in their Crohn's disease symptom score (called a CDAI score) at two specific time points. The numbers reported were: 11 out of 65 in the higher-dose abatacept group, 13 out of 128 in the standard-dose abatacept group, 20 out of 130 in the lower-dose abatacept group, and 18 out of 128 in the placebo group. For the maintenance period, the trial measured how many participants reached a low symptom score (indicating remission, meaning very low disease activity) at 12 months: 10 out of 44 in the abatacept group and 5 out of 46 in the placebo group. For the open-label extension period, the trial tracked unwanted medical events: out of 324 participants, 267 experienced any adverse event, 128 experienced an event considered possibly related to the treatment, 1 participant died, 86 experienced a serious adverse event, 21 experienced a serious adverse event considered possibly related to the treatment, and 16 stopped the study due to an adverse event. For a secondary quality-of-life measure (a questionnaire scored from 32 to 224, where higher means better), the reported average changes from the starting score were 0.79, 11.10, 7.53, and 13.4 points for the higher-dose abatacept, standard-dose abatacept, lower-dose abatacept, and placebo groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00195715 · results posted 7 January 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 777 people, all of whom received the medication adalimumab as an open-label treatment (meaning everyone knew what they were receiving — there was no comparison or placebo group). The trial was studying Crohn's disease, a long-term bowel condition, and the main thing it was measuring was whether participants reached "clinical remission." Remission was defined using a scoring tool called the Crohn's Disease Activity Index (CDAI), which combines eight different health factors measured over a week — a lower score means less severe disease, and a score below 150 was the threshold used to count someone as being in remission. Of the 777 people who started, 400 completed the study and 377 did not. The reported data shows that for the primary (main) outcome, 69.5% of participants were recorded as reaching clinical remission at the relevant time point. The secondary (additional) outcomes reported three further remission figures at different time points during the study: 59.4%, 68.8%, and 46.7% of participants. The reported data also shows that 91.2% of participants had their CDAI score drop by at least 70 points from their starting score (called a CR-70 response), and 85.7% had their score drop by at least 100 points (called a CR-100 response) — both of these are ways of measuring how much a participant's score changed, rather than whether they crossed the remission threshold. It is worth noting that because there was only one group in this trial and no comparison group, the reported numbers describe what was observed in participants taking adalimumab but cannot be directly compared to an untreated or differently treated group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.