Evaluating Oral Ozanimod Treatment for Moderate to Severe Ulcerative Colitis in Children and Teens Not Responding to Standard Therapies

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ozanimod RPC1063 in helping children and teenagers with moderate to severe active ulcerative colitis UC who have not responded well to standard treatments. The study focuses on whether ozanimod can help achieve and maintain clinical remission in this young population. This research is conducted as a phase 2 and phase 3 trial sponsored by Bristol-Myers Squibb. Participants will receive ozanimod orally in either a high dose or low dose as part of the study. The treatment is given on specified days, and participants are randomly assigned to one of these dosing groups. The study uses a quadruple masking design, meaning that participants, caregivers, investigators, and assessors do not know which dose is given. The main study period will last up to 52 weeks, with ongoing assessments for up to 6 years to monitor longer-term outcomes and safety. During the study, participants will be monitored regularly for clinical remission, symptomatic remission, clinical response, and endoscopic improvement at various time points including weeks 10 and 52. Researchers will also track corticosteroid-free remission and measure blood levels of the drug and its metabolites. Safety is closely observed by recording adverse events, serious adverse events, and events leading to treatment discontinuation. The study involves clinical visits, endoscopic exams, and laboratory tests throughout the treatment and follow-up periods.

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