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Recruiting

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice - IM047-029

Updated: 9 February, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 4

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 88

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Cohort 1 - Advanced therapy-naive
Drug: Ozanimod
Experimental: Cohort 2 - Advanced therapy-exposed
Drug: Ozanimod

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

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