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Pesquisa Study Connect
  • NCT05369832

Recruiting

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

Atualizado: 9 abril, 2024   |   ClinicalTrials.gov

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Detalhes do estudo

  • Phase 4

    Fase

  • Gênero(s)

  • 18+

    Faixa etária

  • 91

    Localização(ões)

  • Recruiting

Opções de tratamento

Braços de tratamento do Estudo
INTERVENÇÃO ATRIBUÍDA
Experimental: Cohort 1 - Advanced therapy-naive
Drug: Ozanimod
Experimental: Cohort 2 - Advanced therapy-exposed
Drug: Ozanimod

Principais critérios de elegibilidade

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

É altamente recomendável que você entre em contato com a BMS para relatar efeitos colaterais (eventos adversos).
Efeitos colaterais (eventos adversos) e outros eventos relatáveis estão definidos aqui.
Relate efeitos colaterais (eventos adversos) ou reclamações sobre a qualidade do produto: Informações médicas

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