Tests ozanimod pills in children with ulcerative colitis
Tests oral ozanimod in children with moderate to severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
Key facts
- Where
- Gdansk, Krakow, Lodz, Rzeszów, Szczecin, Warsaw, and Wroclaw, PolandSee the 9 sites
- Phase
- Phase 2/3
Could this be for you?
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?
Source: NCT05076175, who can take part
Where in Poland
- GdanskGdansk, PolandNo longer taking part
- GdanskGdansk, PolandNo longer taking part
- KrakowKrakow, PolandNo longer taking part
- LodzLodz, PolandNo longer taking part
- RzeszówRzeszów, PolandNo longer taking part
- Twoja Przychodnia SCMSzczecin, PolandTaking people
- Centrum Zdrowia Dziecka w WarszawieWarsaw, PolandTaking people
- WIP Warsaw IBD Point Profesor KierkusWarsaw, PolandTaking people
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuWroclaw, PolandTaking people
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?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT05076175
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.