A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• Local Institution - 0041, Phoenix, Arizona, United States
• University of Arizona, Tucson, Arizona, United States
• Local Institution - 0052, Garden Grove, California, United States
• Loma Linda University Health System, Loma Linda, California, United States
• Cedars-Sinai Medical Center, Los Angeles, California, United States
• Lucile Packard Children's Hospital, Palo Alto, California, United States
• University of California Davis Health, Sacramento, California, United States
• Local Institution - 0007, Hartford, Connecticut, United States
• Local Institution - 0064, Washington D.C., District of Columbia, United States
• Local Institution - 0075, Orlando, Florida, United States
• Local Institution - 0016, Atlanta, Georgia, United States
• Local Institution - 0101, Park Ridge, Illinois, United States

+ 78 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05076175.