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Recruiting

Trial ID IM047-029  |   NCT05369832

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

Summary

  • Phase 4
  • Male and Female Gender icon
  • 18+
    Age Range
  • 92
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria: - A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration - Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores: i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration). - Report of a previous colonoscopy that documents extent of disease Exclusion Criteria: - Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation - Extensive colonic resection or current stoma - Colonic dysplasia that has not been removed Other protocol-defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Cohort 1 - Advanced therapy-naive

ASSIGNED INTERVENTION
  • Drug: Ozanimod

Study Arms

Experimental: Cohort 2 - Advanced therapy-exposed

ASSIGNED INTERVENTION
  • Drug: Ozanimod
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