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Recruiting

Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - RPC01-3102

Actualizada: 21 enero, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 12+

    Rango de edad

  • 18

    Ubicaciones

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: RPC0163 (Ozanimod)
Drug: RPC1063

Criterios clave de elegibilidad

Inclusion Criteria: - Aged 18 to 75 years (at screening for Cohorts 1 and 2) - Male of Female adolescent patients aged 12 to < 18 years (at screening) with a body weight > or = 45kg (Cohort 3) - Ulcerative colitis confirmed on endoscopy - Moderately to severely active ulcerative colitis (Mayo score 6-12) - Currently receiving treatment with aminosalicylates, prednisone or budesonide - Can be receiving azathioprine, mercaptopurine, or methotrexate but treatment will be stopped prior to randomization Exclusion Criteria: - Have severe extensive colitis as evidenced by: - Physician judgement that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline - Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation - Diagnosis of Crohn's disease, indeterminate colitis, or the presence of a fistula consistent with Crohn's disease or microscopic colitis, radiation colitis, or ischemic colitis - Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk - History of uveitis or known macular edema - Pregnancy, lactation, or a positive serum B-hCG measured during screening

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