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
- Atlanta, Boston, Chapel Hill, Charleston, Charlotte, Cleveland, Detroit, Fort Worth, Garden Grove, Hartford, Hershey, Houston, Indianapolis, Iowa City, Loma Linda, Los Angeles, Milwaukee, New York, Oklahoma City, Orlando, Palo Alto, Park Ridge, Phoenix, Portland, Rochester, Sacramento, Seattle, Springfield, St Louis, Tacoma, Tucson, Washington D.C., and Worcester, United StatesSee the 36 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 United States
- AtlantaAtlanta, United StatesNo longer taking part
- Boston Children's HospitalBoston, United StatesTaking people
- University of North Carolina Medical CenterChapel Hill, United StatesNo longer taking part
- CharlestonCharleston, United StatesNot yet recruiting
- CharlotteCharlotte, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesTaking people
- DetroitDetroit, United StatesNo longer taking part
- Fort WorthFort Worth, United StatesNot yet recruiting
- Garden GroveGarden Grove, United StatesNo longer taking part
- HartfordHartford, United StatesNo longer taking part
- HersheyHershey, United StatesNo longer taking part
- Texas Children's HospitalHouston, United StatesTaking people
- IndianapolisIndianapolis, United StatesNot yet recruiting
- Iowa CityIowa City, United StatesNo longer taking part
- Loma Linda University Health SystemLoma Linda, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- MilwaukeeMilwaukee, United StatesNo longer taking part
- Columbia University Medical CenterNew York, United StatesTaking people
- New YorkNew York, United StatesNo longer taking part
- New YorkNew York, United StatesNo longer taking part
- Oklahoma CityOklahoma City, United StatesNo longer taking part
- OrlandoOrlando, United StatesNo longer taking part
- Lucile Packard Children's HospitalPalo Alto, United StatesNot yet recruiting
- Park RidgePark Ridge, United StatesNot yet recruiting
- PhoenixPhoenix, United StatesNo longer taking part
- Maine Medical PartnersPortland, United StatesNot yet recruiting
- Mayo Clinic in Rochester, MinnesotaRochester, United StatesTaking people
- University of California Davis HealthSacramento, United StatesTaking people
- Seattle Children's HospitalSeattle, United StatesTaking people
- SeattleSeattle, United StatesNo longer taking part
- SpringfieldSpringfield, United StatesNo longer taking part
- Washington UniversitySt Louis, United StatesTaking people
- MultiCare Health SystemTacoma, United StatesTaking people
- University of ArizonaTucson, United StatesNo longer taking part
- Washington D.C.Washington D.C., United StatesNo longer taking part
- University of Massachusetts Chan Medical SchoolWorcester, United StatesTaking 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.