NCT05076175

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Ozanimod	Specified dose on specified days

Timeline

• Start date: 2022-05-30
• Primary completion: 2026-05-22
• Completion: 2031-08-14
• First posted: 2021-10-13
• Last updated: 2026-04-07

Locations

90 sites across 13 countries: United States, Australia, Belgium, Canada, France, Germany, Israel, Japan, Poland, Puerto Rico, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study