Reported trial results for Coeliac Disease

13 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

• NCT05574010 · results posted 10 March 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT05574010) tested a drug called KAN-101 in people with coeliac disease. The trial was run in three parts (A, B, and C) and enrolled a total of 128 participants across ten groups, receiving either different doses of KAN-101 (0.6, 1.2, or 3.0 mg per kilogram of body weight) or a placebo (a dummy treatment with no active ingredient). Part A looked at unwanted medical events (called adverse events) that occurred after dosing. Parts B and C measured changes in a blood protein called IL-2 — a substance that tends to rise in people with coeliac disease when they are exposed to gluten — before and after a deliberate gluten challenge. The reported data shows that in Part A, all 3 participants in the lower-dose group and all 3 in the higher-dose group experienced at least one adverse event of some kind. No participants in either group experienced what would be classified as a severe or higher-grade event, although one participant in the higher-dose group had a moderate (Grade 2) event. For the IL-2 blood marker measured in Parts B and C, the reported data shows that participants receiving the placebo had noticeably larger increases in IL-2 after the gluten challenge compared to those in the KAN-101 dose groups. For example, in Part B the placebo group's IL-2 change was reported as 146.2 international units, while the two KAN-101 groups showed changes of −2.3 and −1.9 (meaning little to no rise). Similar patterns were reported in Part C, where the placebo group's change was 119.1 international units compared to figures of 6.5 to 13.2 in the KAN-101 groups. The reported data also includes blood concentration measurements for KAN-101, which showed higher levels in the body at the higher dose, as would generally be expected. 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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• NCT06001177 · results posted 18 December 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people in total — 28 received a treatment called KAN-101 (at a dose of 0.6 mg/kg) and 27 received a placebo (a dummy treatment with no active ingredient). All participants had coeliac disease. The trial was measuring how the gut lining responded after participants were deliberately exposed to gluten for two weeks — a process called a "gluten challenge." The main thing researchers were tracking was a ratio called villous height to crypt depth (Vh:Cd), which is a way of measuring the tiny finger-like structures in the small intestine that can become damaged in coeliac disease. Several secondary measurements were also taken, including immune system responses and the presence of certain immune cells in the gut lining. The reported data shows that after the two-week gluten challenge, the Vh:Cd ratio (gut lining structure) changed by −0.85 in the KAN-101 group and −0.61 in the placebo group — meaning both groups showed a decrease in this measurement from their starting point, with the KAN-101 group showing a slightly larger decrease. For one immune response marker (IL-2, a protein involved in immune signalling), the reported figures were very similar between the two groups: 31.8 units in the KAN-101 group and 31.1 units in the placebo group. For a measure of immune cells in the gut lining (called intraepithelial lymphocytes), the reported change was 20.68 cells per 100 epithelial cells in the KAN-101 group and 17.36 in the placebo group. Regarding unwanted medical events during the trial (called adverse events), 25 out of 28 participants in the KAN-101 group and 22 out of 27 in the placebo group experienced at least one such event. A small number of participants in the KAN-101 group developed antibodies against the study drug at later time points (3 participants at one visit, 5 at another). The data for one pharmacokinetic measurement (how the drug was absorbed into the bloodstream over time) was noted as not available 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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• NCT04424927 · results posted 20 October 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04424927) tested a drug called PRV-015 in people with coeliac disease. The trial ran in two stages: first, all 388 participants took a placebo (a dummy treatment with no active ingredient) for four weeks — 352 of them completed this stage. Then, 226 of those participants moved into a 24-week double-blind stage, where they were randomly assigned to receive either a placebo or one of three doses of PRV-015 (100 mg, 300 mg, or 600 mg), with roughly 56–57 people in each group. Neither the participants nor the researchers knew who was receiving which treatment during this second stage. The trial was measuring changes in coeliac disease symptoms — things like stomach cramping, pain, bloating, gas, diarrhoea, and loose stools — using a daily questionnaire where each symptom was rated from 0 (none) to 10 (worst possible). The reported data shows that for the main outcome — a combined score covering abdominal symptoms (cramping, pain, bloating, and gas, scored out of 40) — all four groups showed a small reduction from their starting scores over 24 weeks. The placebo group's score fell by 1.32 points on average, while the three PRV-015 groups fell by 1.28, 1.21, and 1.28 points respectively. For the secondary symptom scores (diarrhoea and loose stools, and overall gut symptoms), similarly small reductions were reported across all groups. A separate measure looked at a type of inflammation in the small intestine (called intraepithelial lymphocyte density — essentially a count of certain immune cells in the gut lining). The reported data shows the placebo group's count changed by −0.39 cells per 100 epithelial cells, the 100 mg group's count increased by 1.54, and the 300 mg and 600 mg groups' counts fell by 4.11 and 4.53 respectively. The reported data also shows that during the double-blind period, 34 participants in both the placebo and 100 mg groups, 36 in the 300 mg group, and 29 in the 600 mg group experienced at least one adverse event (an untoward medical occurrence during the study). Serious adverse events were reported in 1 participant each in the placebo and 100 mg groups, and 2 in the 300 mg group, with none in the 600 mg group. Some changes in blood test results (haematology) were also recorded for small numbers of participants across all groups, as detailed in the full 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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• NCT04604795 · results posted 9 May 2023

  According to the results reported on ClinicalTrials.gov, this trial studied a drug called GSK3915393 and was conducted in three separate parts (A, B, and C). Part A involved 12 participants split across four small groups of 3, who each received different combinations of the drug, a placebo (a dummy treatment with no active ingredient), or an intravenous (drip) dose across multiple treatment periods. Part B enrolled 38 participants split into four groups — one placebo group and three groups receiving different doses of GSK3915393 taken by mouth, over up to 14 days. Part C involved 12 participants across two groups who received the drug under different conditions, including alongside other substances, to see how those combinations affected the way the drug moved through the body. The trial was primarily measuring how the body absorbed, processed, and cleared the drug — information researchers use to understand dosing before larger studies. The reported data shows that across all parts of the trial, the measurements collected were focused on how the drug behaved in the body at different doses and under different conditions (for example, with food, with other medicines, or given as a drip versus a tablet). The specific numbers for the primary and secondary outcome measures — such as the levels of the drug detected in the blood and how long it stayed in the body — were not fully reported in the structured results data submitted to ClinicalTrials.gov, so those figures cannot be described here. What the data does show is that the large majority of participants completed their assigned treatment periods, with only small numbers not completing certain stages. It is worth noting that this was an early-phase study involving very small numbers of people, and its purpose was to gather information about how GSK3915393 behaves in the body rather than to test whether it treats any particular condition. The reported data from this kind of study is a step in a longer research process. 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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• NCT03866538 · results posted 26 August 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03866538) was designed to compare two groups of people with coeliac disease who were taking a medicine called budesonide — one group would keep taking it, and the other would stop. The trial aimed to measure changes in the lining of the small bowel (using a camera procedure with tissue samples), as well as changes in symptoms, quality of life, body weight, iron levels, and vitamin D levels. In total, only one participant was recorded as having started and completed the trial, and no participants were recorded in the "Continued Budesonide" group. The reported data shows that no numerical results were submitted for any of the outcome measures — not for the small bowel tissue findings, symptom scores, quality of life questionnaire results, weight, iron, or vitamin D. Because the trial enrolled only one participant instead of the intended two groups, the measurements for all primary and secondary outcomes were not reported. Given that almost no participants took part, the trial was not able to produce any comparative findings between the two groups. The reasons for this were not explained in the submitted data, and any conclusions that the study originally set out to test remain unanswered based on what has been 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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• NCT04227197 · results posted 14 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04227197) enrolled 230 people in total — 117 in the intervention group and 113 in the control group. The trial was looking at care for children and young people with Down syndrome, and was measuring whether a support tool (described as "Down Syndrome Clinic to You") helped families and their regular doctors follow through on five health checks recommended by national guidelines for Down syndrome: a coeliac screen, a sleep study, a thyroid test, a hearing test, and an eye assessment. Caregivers and doctors were surveyed at two weeks and again at seven months after a primary care visit. The reported data shows that, for the main outcome — the number of participants whose indicated health checks were either completed or recommended by their doctor — the numbers across different levels of check completion were similar between the two groups. For example, 69 participants in the intervention group and 79 in the control group fell into one reported category, while 36 (intervention) versus 31 (control) fell into another, 10 versus 3 into a third, and 2 versus 0 into a fourth. The trial also measured quality of life using standard questionnaires scored from 0 to 100 (higher meaning better). The reported data shows that starting scores were similar between groups (around 63–72 out of 100 depending on the subdomain), and the changes measured at two weeks and seven months were small in both groups, ranging roughly from a slight decrease to a slight increase across the different subdomains. For the caregiver experience survey (intervention group only), the reported data shows that out of 94 doctors who responded, 55 reported that caregivers gave them a copy of the care plan before or during the visit, 25 reported receiving it during the visit only, 11 reported not receiving it, and 3 gave another response. No safety or quality-of-life data was reported for the seven-month caregiver experience subgroup 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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• NCT00931892 · results posted 4 June 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 adults in total — 10 in a "low gluten" group and 10 in a "high gluten" group. All 20 completed the gluten challenge phase and the first two rounds of gut tissue sampling (endoscopies). In the third endoscopy, one person in the high gluten group did not complete it, leaving 9 in that group at the final stage. The trial was measuring what happens to the lining of the small bowel — and to certain immune and symptom markers — when people with coeliac disease are exposed to different amounts of gluten over a short period. The reported data shows that the main thing being measured was the ratio of the finger-like projections in the gut lining (villi) compared to the depth of the surrounding pits (crypts) — a higher ratio generally indicates a healthier gut lining, with 3:1 or above considered normal. For the low gluten group, the reported ratio started at 2.05 at baseline (Day −14), dropped to 1.19 by Day 3, and fell further to 0.98 by Day 14. For the high gluten group, the ratio started higher at 4.33, then fell to 2.02 at Day 3, and to 1.26 by Day 14. The reported data also shows counts of certain immune cells in the gut lining (intraepithelial lymphocytes per 100 gut-lining cells): the low gluten group went from 37.08 at baseline to 47.95 at Day 14, and the high gluten group went from 28.91 at baseline to 52.36 at Day 14. For the immune blood markers (tissue transglutaminase and deamidated gliadin peptide antibodies, where scores above 30 are considered positive on the scale used), both groups remained in the negative range during the challenge but the reported Day 28 figures rose — the low gluten group averaged 37.81 and the high gluten group averaged 43.20. Symptom scores (on a scale of 7–80, where higher means more symptoms) were broadly similar across both groups throughout the study, ranging roughly between the mid-20s and low 30s at various 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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• NCT03738475 · results posted 12 August 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03738475) enrolled 34 adults in total — 16 received a treatment called TIMP-GLIA at a dose of 8 mg/kg, and 18 received a placebo (a dummy treatment). One person in the TIMP-GLIA group did not complete the trial; everyone in the placebo group finished. The trial was designed to measure how the immune system responded to gluten (a protein found in wheat and related grains) in people with coeliac disease, looking at changes in certain immune cells and intestinal tissue after a period of deliberate gluten exposure. The reported data shows the following numbers for the main measurement — a count of immune cell activity in the blood triggered by gluten (called interferon-gamma spot-forming units) — the TIMP-GLIA group started at 3.08 units and changed by 2.01 units from their baseline, while the placebo group started at 1.98 units and changed by 17.57 units from their baseline. For the intestinal measurements taken at day 29, the trial looked at the ratio of tiny finger-like projections in the gut (villi) to the grooves between them (crypts) — a lower ratio can indicate more gut damage. The reported data shows the TIMP-GLIA group's ratio changed by −0.18 from baseline (starting at 2.82), while the placebo group's ratio changed by −0.63 (starting at 3.01). Additionally, 23.1% of participants in the TIMP-GLIA group showed a meaningful drop (0.4 or more) in this gut ratio, compared with 53.3% in the placebo group. Several other blood-based immune measurements were also reported, with generally small numerical differences between the two groups across 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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• NCT02633020 · results posted 27 December 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02633020) looked at a treatment called AMG 714 in people with refractory coeliac disease type 2 — a rare and serious form of coeliac disease that does not respond to a gluten-free diet. A total of 28 people took part: 19 received AMG 714 and 9 received a placebo (a dummy treatment with no active ingredient). The trial was mainly measuring changes in a type of abnormal white blood cell found in the gut lining, called aberrant intraepithelial lymphocytes, which are a key feature of this condition. Several other measures were also tracked, including gut tissue structure and bowel movement frequency. The reported data shows that for the main outcome — the percentage change in these abnormal white blood cells compared to the start of the study — the AMG 714 group showed a reported change of approximately 2.45%, while the placebo group showed approximately 7.30%. For a secondary measure that looked at these same cells in a slightly different way, the AMG 714 group showed a reported change of around 11.66%, compared to 49.88% in the placebo group. Regarding gut tissue structure (the ratio of finger-like projections to grooves in the small intestine, where a higher ratio is generally considered better), the AMG 714 group showed a reported change of approximately 26.44% compared to 15.77% in the placebo group. Around 35% of participants in the AMG 714 group and 33% in the placebo group showed an improvement on a standard gut damage scoring system. The reported data shows that weekly bowel movements were approximately 10–11 per week in the AMG 714 group and 7–8 per week in the placebo group across the study period, though the full breakdown of these figures was not fully separated in the reported 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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• NCT02637141 · results posted 3 December 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 64 people in total across three groups: 22 received a lower dose of the investigational drug AMG 714 (150 mg), 22 received a higher dose (300 mg), and 20 received a placebo (an inactive treatment). All participants had coeliac disease and were deliberately exposed to gluten during the study — a method used to observe how the small intestine responds. The trial was primarily measuring changes in the structure of the small intestine lining, specifically a ratio comparing the height of tiny nutrient-absorbing projections (villi) to the depth of the grooves between them (crypts). A lower ratio generally indicates more intestinal damage. Most participants completed the study, with only five people across all three groups not finishing. The reported data shows that after 12 weeks, the villi-to-crypt ratio had decreased in all three groups. The 150 mg AMG 714 group showed a reported decrease of around 63%, the 300 mg group around 54%, and the placebo group around 60%. For one of the secondary measures — levels of certain immune cells in the intestinal lining (intraepithelial lymphocytes, which tend to be elevated in coeliac disease) — the reported data shows these increased in all groups: by about 95% in the 150 mg group, 68% in the 300 mg group, and 109% in the placebo group. When researchers looked at a standard grading system for intestinal damage (the Marsh score), zero participants in any group showed an improvement. Two blood markers related to coeliac disease (anti-tTG IgA antibodies and anti-DGP antibodies) were also measured and showed increases across all groups, with the increases appearing larger in the AMG 714 groups than in the placebo group. Weekly bowel movements were recorded at roughly 9–10 per week at the start across groups, and appeared broadly similar at 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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• NCT01439035 · results posted 26 September 2018

  According to the results reported on ClinicalTrials.gov, this was a small pilot trial (registered as NCT01439035) that enrolled 6 participants, all of whom completed the study. The trial was testing a medical imaging technique called Optical Frequency Domain Imaging (OFDI) — a type of detailed internal camera scan — to see whether it could detect changes in the tiny finger-like projections lining the small intestine (called villi) that are associated with coeliac disease. The researchers compared what the OFDI scan showed against standard tissue samples (biopsies) taken during the same procedure. The reported data shows that all 6 participants had their OFDI images analysed and compared to their biopsy results. The primary outcome measured how many participants had intestinal changes that could be identified using the OFDI imaging technique. According to the results reported on ClinicalTrials.gov, the recorded value for this outcome was 6 out of 6 participants. No additional numerical detail beyond this count was provided in the submitted results data. It is worth noting that this was described as a pilot study — meaning it was a very early, small-scale investigation intended to explore whether the imaging approach was feasible to use, rather than to draw broad conclusions. No secondary outcome data appears to have been 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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• NCT01787825 · results posted 10 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 121 people in total — 60 starting with one capsule camera device (CapsoCam SV-1) before crossing over to the other (PillCam SB2), and 61 doing it in the reverse order. This was a crossover study, meaning every participant used both swallowable camera capsules, which are small pill-sized devices that take pictures as they travel through the small bowel (the middle part of the digestive system). The trial was comparing the two devices by looking at whether the images they each captured led reviewers to the same conclusions about whether a person's small bowel appeared normal or abnormal. The reported data shows that for the main question — whether the bowel looked normal or abnormal — 42 participants were assessed as "normal" and 72 as "abnormal" for both the CapsoCam SV-1 and the PillCam SB2, suggesting the two sets of reviewers reached the same overall count for each device. For the time it took each capsule to travel through the small bowel, the reported data shows an average of 4.1 hours for CapsoCam SV-1 and 3.6 hours for PillCam SB2. When it came to what the reviewers identified in the images (referred to as "diagnostic yield"), the reported numbers were broadly similar between the two devices across the categories measured, though the data as submitted does not include labels for each individual category. On the question of which device participants personally preferred, the reported data shows 89 people said they preferred CapsoCam SV-1 and 24 said they preferred PillCam SB2. 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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• NCT01661933 · results posted 13 October 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 12 participants, all of whom had been infected with a small number of *Necator americanus* hookworms and then exposed to increasing amounts of gluten over time. The trial was broken into three stages — a tiny gluten exposure, a low-dose gluten challenge, and a high-dose gluten challenge — with all 12 participants completing the first stage, 10 completing the second, and 8 completing the third. The study was primarily measuring whether the lining of the small bowel (the gut's inner wall) stayed intact during gluten exposure, using a measurement called the villus height to crypt depth ratio — essentially a way of comparing the height of tiny finger-like projections in the gut lining to the depth of the pits between them. A lower ratio can indicate gut damage. The reported data shows that the primary gut lining measurement (villus height to crypt depth ratio) was recorded as 2.73 at two separate time points for the group. For the secondary outcomes, immune cells in the gut lining (called intraepithelial lymphocytes, which tend to increase when the gut is reacting to gluten) were reported at 33.40% and 35.00% at two time points. A separate scoring system for gut inflammation (the Marsh score, where higher numbers indicate more severe changes) showed that 1 participant had a meaningful worsening of their score after the low-dose gluten challenge. Additionally, a blood marker linked to coeliac disease activity (anti-tissue transglutaminase antibodies, where levels below 15 units/mL are considered normal) was reported at three time points: 4.12, 2.99, and 2.11 units/mL — all below the normal cut-off threshold used in the 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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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.