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Trial ID IM047-029  |   NCT05369832

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

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Summary

  • Phase 4
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not 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.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • 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
    1. Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:
      1. An SF subscore ≥ 1, AND
        1. An RB subscore ≥ 1, AND
          1. An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).
          2. Report of a previous colonoscopy that documents extent of disease

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation
              1. Extensive colonic resection or current stoma
                1. Colonic dysplasia that has not been removed Other protocol-defined inclusion/exclusion criteria apply
                  Additional Information *

                  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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