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 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 41677183) ↗
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 are between 18 and 75 years old
- You have been diagnosed with ulcerative colitis (UC), confirmed by a camera examination of the bowel (endoscopy)
- Your ulcerative colitis is classed as moderately to severely active, based on a standard scoring system used by doctors
- You are currently being treated with one of these medicines: aminosalicylate, prednisone, or budesonide
- You may be taking azathioprine, mercaptopurine, or methotrexate, but you would need to stop taking it before the trial begins
Who may not be able to join:
- Your doctor believes you are likely to need bowel surgery (colectomy or ileostomy) within 12 weeks
- You have had or currently have a very severe flare-up of colitis, a dangerously enlarged bowel (toxic megacolon), or a hole in the bowel within the last 3 months
- You have been diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis, radiation colitis, or ischemic colitis (a type of colitis caused by reduced blood flow)
- You have a significant heart or other health condition that could affect your safety or the trial results (confirm with trial site)
- You have a history of eye inflammation (uveitis) or unexplained swelling at the back of the eye (macular edema)
- You are pregnant, breastfeeding, or a pregnancy test during screening came back positive
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: AnnKatrin Petersen, M.D., MSc., Celgene
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
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants in Clinical Remission at 10 Weeks; Percentage of Participants in Clinical Remission at 52 Weeks
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.