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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 19 years and older
• All sexes
• Adult, Older adult

Study population: The study population will consist of participants with moderately to severely active ulcerative colitis who will receive at least 1 dose of ozanimod according to local product label. Moderate to severe disease will be defined as a Mayo score of 6 to 12 and an endoscopic sub-score of 2 or higher. Participants will be eligible if they had an inadequate response, lost response, or were intolerant to conventional therapy (5-aminosalicylic acid, corticosteroids, immunosuppressants) or biologic agents.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Ulcerative Colitis

Being tested

Ozanimod

Medical subject headings

Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• OzanimodDrug

  According to local product label

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Adverse events

   The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod

   Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Oct 2023
2. Study start19 Apr 2024
3. Primary completion1 Apr 2028 (estimated)
4. Study completion1 Apr 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
• More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.