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Recruiting

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

Uppdaterad: 9 april, 2024   |   ClinicalTrials.gov

Utskriftsvänlig sammanfattning

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Information om prövningen

  • Phase 4

    Fas

  • Kön

  • 18+

    Åldersintervall

  • 91

    Platser

  • Recruiting

Behandlingsalternativ

Studiegrupper
TILLDELAD BEHANDLING
Experimental: Cohort 1 - Advanced therapy-naive
Drug: Ozanimod
Experimental: Cohort 2 - Advanced therapy-exposed
Drug: Ozanimod

Viktiga kriterier för deltagandet

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 5 through 9, inclusive - 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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