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 (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.
View full results on ClinicalTrials.gov ↗
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 2 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 (UC) — a condition causing inflammation in the large intestine — that spreads at least 15 cm inside the bowel, confirmed by a camera test (colonoscopy or sigmoidoscopy) before joining the trial
- You have had a confirmed diagnosis of ulcerative colitis for at least 3 months before the screening visit
- Your ulcerative colitis is currently moderate to severe, based on a specific scoring system that measures how often you visit the toilet, whether you have rectal bleeding, and results from your camera test (confirm with trial site)
Who may not be able to join:
- You have been diagnosed (now or in the past) with Crohn's disease, indeterminate colitis, ischemic colitis, or a certain type of colitis called pseudomembranous colitis (unless it was caused by a specific bacterial infection called C. difficile)
- A stool (poo) sample taken at your screening visit tested positive for a harmful bacteria called C. difficile
- You have had a very severe flare-up of colitis, a pocket of infection in your abdomen, a dangerous swelling of the colon, or a hole in the bowel within the last 12 weeks before joining the trial
- There may be additional requirements not listed here (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: Bristol-Myers Squibb, Bristol-Myers Squibb
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Clinical Remission Response Rate at Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.