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ID del estudio RPC01-3102  |   NCT02531126

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

Resumen

  • Phase 3
  • Ícono de género masculino y femenino
  • 12+
  • 18
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

The purpose of this study is to determine the long-term safety of RPC1063 for the treatment of all patients with moderate to severe Ulcerative Colitis (UC) as well as the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC. Additionally, to determine the long-term efficacy of RPC1063 for the treatment of adolescent patients with moderate to severe UC.

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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

Opciones de tratamiento

Brazos del estudio

INTERVENCIÓN ASIGNADA

Brazos del estudio

Experimental: RPC0163 (Ozanimod)

INTERVENCIÓN ASIGNADA
  • Drug: RPC1063
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