RecruitingNCT06073873

A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea


Sponsor

Bristol-Myers Squibb

Enrollment

3,000 participants

Start Date

Apr 19, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This is a post-marketing safety surveillance study in Korea for ozanimod (brand name Zeposia), a medication for adults with moderate to severe active ulcerative colitis — a type of inflammatory bowel disease causing ongoing gut inflammation. The goal is to track real-world safety data after approval. **You may be eligible if...** - You are 19 or older (Korean adult) - You have moderate to severe active ulcerative colitis - Your doctor has prescribed ozanimod according to the approved Korean label - You have signed informed consent voluntarily **You may NOT be eligible if...** - You are being prescribed ozanimod for an unapproved use in Korea - You have a medical contraindication to ozanimod according to the Korean prescribing information Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOzanimod

According to local product label


Locations(1)

Bristol-Myers Squibb YH

Seoul, South Korea

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NCT06073873


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