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Pesquisa Study Connect
  • NCT05076175

Recruiting

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis - IM047-001

Atualizado: 4 fevereiro, 2025   |   ClinicalTrials.gov

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SELECIONAR IDIOMA

Detalhes do estudo

  • Phase 2/Phase 3

    Fase

  • Gênero(s)

  • 2-17

    Faixa etária

  • 38

    Localização(ões)

  • Recruiting

Opções de tratamento

Braços de tratamento do Estudo
INTERVENÇÃO ATRIBUÍDA
Experimental: Ozanimod High Dose
Drug: Ozanimod
Experimental: Ozanimod Low Dose
Drug: Ozanimod

Principais critérios de elegibilidade

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: - Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit - Evidence of UC extending beyond the rectum, as determined by baseline endoscopy - Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy Exclusion Criteria: - Diagnosis of Crohn's disease or indeterminate colitis - Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool - Apheresis within 2 weeks of randomization - History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis 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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