Tests ozanimod pills in children with ulcerative colitis
Tests oral ozanimod in children with moderate to severe ulcerative colitis.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- San Juan, Puerto RicoSee the siteAlso in 12 other countries, 90 sites
- Trial code
- Registry title
- A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 120 people, planned
- Started
- 30 May 2022
- Expected to end
- 12 Jul 2032
- Type of study
- Interventional, 2 groups
- Treatments tested
- Ozanimod
- Record updated
- 20 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with moderate to severe active ulcerative colitis who did not respond well to usual treatments. It tests the pill ozanimod.
- Age
- 2 Years to 17 Years
- Sex
- All sexes can join.
- Disease stage
- Moderately to severely active ulcerative colitis, diagnosed before screening. The disease reaches beyond the rectum, seen on a baseline endoscopy.
- Earlier treatment
- Must have had an inadequate response, lost response, or not tolerated at least 1 of these: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy.
Main reasons for not taking part
- Crohn's disease or indeterminate colitis
- Positive stool test for toxin producing Clostridium difficile
- Apheresis within 2 weeks of randomization
- Current or past primary or secondary immunodeficiency
- Known genetic disorder as the cause of colitis
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
- Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
- Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
Who cannot take part
- Diagnosis of Crohn's disease or indeterminate colitis
- History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis
- Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
- Apheresis within 2 weeks of randomization
- Other protocol-defined inclusion/exclusion criteria apply
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Where in Puerto Rico
Also in 12 other countries, 90 sites
- Clinical Research Puerto RicoSan Juan, Puerto RicoContact: Antonio Del Valle-Segarra, Site 0098Taking people
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
The 2 groups in the trial
- Ozanimod High DoseTreatment being tested
Treatment: Ozanimod
- Ozanimod Low DoseTreatment being tested
Treatment: Ozanimod
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy
- Plain-language title
- Tests ozanimod pills in children with ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05076175, who can take part
- Record updated
- 20 October 2026