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

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Drug: Ozanimod

Study type: Observational

Funder types: Industry

Identifiers

NCT06073873

IM047-024

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Participants with moderate to severe active ulcerative colitis treated with ozanimod

Treatment:

Drug: Ozanimod