NCT05644665

A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. The main study is composed of an induction period, maintenance period, safety follow-up, and participants meeting certain criteria will be given the opportunity to participate in an optional open label extension.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Ozanimod	Specified dose on specified days
DRUG	Placebo	Specified dose on specified days

Timeline

• Start date: 2022-12-09
• Primary completion: 2025-03-07
• Completion: 2025-03-07
• First posted: 2022-12-09
• Last updated: 2025-03-26

Locations

51 sites across 2 countries: China, Taiwan