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NCT06073873 Clinical Trial

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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06073873
Other study ID # IM047-024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2024
Est. completion date April 1, 2028

Study information
Verified date April 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date April 1, 2028
Est. primary completion date April 1, 2028
Accepts healthy volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Ozanimod
According to local product label

Locations
Country Name City State
Korea, Republic of Bristol-Myers Squibb YH Seoul

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod Up to 52 weeks
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