drugset / Trial / NCT05644665

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

NCT05644665

Phase 3 Terminated 131 enrolled Bristol-Myers Squibb
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2022-12-09
Primary completion
2025-03-07
Completion
2025-03-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ozanimod Small molecule

Indications