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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06073873

Enrollment

3000

Registered

2023-10-10

Start date

2024-04-19

Completion date

2028-04-01

Last updated

2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

DRUGOzanimod

According to local product label

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Countries

South Korea

Contacts

Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com

Clinical.Trials@bms.com855-907-3286

Backup ContactFirst line of the email MUST contain NCT # and Site #.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026