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Szukaj Study Connect
  • NCT05369832

Recruiting

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

Zaktualizowano: 9 kwiecień, 2024   |   ClinicalTrials.gov

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Szczegóły badania

  • Phase 4

    Etap

  • Płeć

  • 18+

    Zakres wieku

  • 91

    Lokalizacje

  • Recruiting

Opcje leczenia

Grupy badania
PRZYPISANA INTERWENCJA
Experimental: Cohort 1 - Advanced therapy-naive
Drug: Ozanimod
Experimental: Cohort 2 - Advanced therapy-exposed
Drug: Ozanimod

Kluczowe kryteria kwalifikacyjne

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