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A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
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
Who can join
Ages 2 to 17 · All sexes
Full eligibility criteria
Inclusion Criteria * 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 Criteria * Diagnosis of Crohn's disease or indeterminate 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 * History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis * Other protocol-defined inclusion/exclusion criteria apply
About the study
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.
What is being tested
- Ozanimod (drug)
Sponsor: Bristol-Myers Squibb · Participants: 120 · Started: May 30, 2022
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT05076175
Locations in the U.S.
| California | Loma Linda University Health System, Loma Linda Cedars-Sinai Medical Center, Los Angeles Lucile Packard Children's Hospital, Palo Alto (Not yet recruiting) University of California Davis Health, Sacramento |
| Illinois | Local Institution - 0101, Park Ridge (Not yet recruiting) |
| Indiana | Local Institution - 0100, Indianapolis (Not yet recruiting) |
| Maine | Maine Medical Partners, Portland (Not yet recruiting) |
| Massachusetts | Boston Children's Hospital, Boston University of Massachusetts Chan Medical School, Worcester |
| Minnesota | Mayo Clinic in Rochester, Minnesota, Rochester |
| Missouri | Washington University, St Louis |
| New York | Columbia University Medical Center, New York |
| Ohio | Cleveland Clinic, Cleveland |
| South Carolina | Local Institution - 0099, Charleston (Not yet recruiting) |
| Texas | Local Institution - 0103, Fort Worth (Not yet recruiting) Texas Children's Hospital, Houston |
| Washington | Seattle Children's Hospital, Seattle MultiCare Health System, Tacoma |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.