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

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Ozanimod

• Registration Number: NCT06073873
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Study Start: 2024-04-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2028-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Adult participants 19 years of age or older
• Participants who will receive ozanimod according to the approved label after enrollment
• Participants who sign the informed consent form voluntarily

Exclusion Criteria

• Participants who are prescribed ozanimod for therapeutic indications not approved in Korea
• Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with moderate to severe active ulcerative colitis treated with ozanimod	Ozanimod	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Up to 52 weeks	The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod

Trial Locations

Locations (1)

Bristol-Myers Squibb YH; 🇰🇷 Seoul, Korea, Republic of