Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40875187) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Crohn's Disease and Colitis Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You have been diagnosed with ulcerative colitis for at least 90 days, confirmed by a colonoscopy during the screening period, with no signs of current infection or cancer in the colon.
- Your ulcerative colitis is currently active, with disease activity scores in a moderate range as measured by a colonoscopy and a scoring system called the Adapted Mayo score (confirm with trial site).
- You have tried at least one standard treatment (such as aminosalicylates, steroids, immune-suppressing medicines, or biologic therapies) but it did not work well enough, stopped working, or you could not tolerate it.
- If you are female, you must meet the trial's specific contraception requirements and have negative pregnancy tests at both the screening and baseline visits.
- You may be eligible if you are 16 or 17 years old, depending on the country where the trial is taking place, if you weigh at least 40 kilograms and have reached full physical maturity (confirm with trial site).
Who may not be able to join:
- You have been diagnosed with Crohn's disease or a condition called indeterminate colitis.
- You currently have a very severe form of colitis called fulminant colitis or a dangerous bowel condition called toxic megacolon.
- Your ulcerative colitis affects only the rectum (known as ulcerative proctitis).
- You have taken certain immune-suppressing medicines (cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide) within the last 30 days.
- You have taken azathioprine or 6-mercaptopurine within the last 10 days.
- You have received steroid treatment through an IV within the last 14 days or during the screening period.
- You have previously taken a type of medicine called a JAK inhibitor (examples include tofacitinib, baricitinib, filgotinib, or upadacitinib).
- Your blood tests or other screening results show abnormal values that fall outside the trial's accepted range (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: ABBVIE INC., AbbVie
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8; Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8; Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.