NCT05470985

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• 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 efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Ozanimod	Specific dose on specific days

Timeline

• Start date: 2023-08-22
• Primary completion: 2024-09-13
• Completion: 2024-09-13
• First posted: 2022-07-22
• Last updated: 2025-04-22
• Results posted: 2025-04-22

Locations

46 sites across 9 countries: United States, Australia, Belgium, Canada, France, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study