A Phase 4 Prospective Open label Study of Ozanimod to Explore the Safety Efficacy Quality of Life and Biomarker Response in Participants with Moderate to Severe Ulcerative Colitis in Clinical Practice

Brief description of study

Ulcerative colitis (UC) is a chronic inflammatory disorder affecting the gastrointestinal tract. Patients with UC experience symptoms such as diarrhea, rectal bleeding, weight loss, abdominal pain, and fever. Additionally, individuals with UC have a higher risk of developing carcinoma compared to the general population.

This study aims to evaluate the effectiveness of ozanimod (ZEPOSIA®), a sphingosine 1-phosphate (S1P) receptor modulator, which is approved for treating both ulcerative colitis and multiple sclerosis in several countries, including the United States, Canada, the European Union, and the United Kingdom. Ozanimod is available by prescription and is administered orally in capsule form. The ongoing research seeks to further assess its effectiveness, safety, tolerability, long-term response, and impact on quality of life and biomarkers in patients with UC.

The study is open-label, meaning both you and your study doctor will know that you will receive ozanimod if you qualify. Participants will be divided into two groups (Cohort 1 and Cohort 2) based on their previous UC medication use. Cohort 1 will include individuals with only prior exposure to standard UC treatments, while Cohort 2 will consist of those with a history of advanced UC therapies.


Clinical Study Identifier: s22-01402
ClinicalTrials.gov Identifier: NCT05369832
Principal Investigator: David P Hudesman.
Other Investigators: Adam Faye, Ariela Holmer, Simon J Hong, Jordan E Axelrad, Shannon Chang.


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