Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Clinical Trial ID: NCT02435992

Description

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 3 separate cohorts (Cohort 1 and Cohort 2 for adults, Cohort 3 for adolescents). Patients from Cohort 1, 2, and 3 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1, 2, and 3 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.


Criteria

Inclusion Criteria: - Aged 18 to 75 years (at screening for Cohort 1 and 2) - Male or female adolescent patients aged 12 to < 18 years (at screening) with a body weight greater than or equal to 45 kg - UC confirmed on endoscopy - Moderately to severely active UC (May score 6-12) - Currently receiving treatment with aminosalisylate, 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 evidence by: - Physician judgment 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 CD, indeterminate colitis, or the presence of fistula consistent with CD 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 unknown macular edema - Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

  • Start Date

    2015-06-17

  • Last Updated

    2020-01-29

  • Sponsor

    Celgene

  • Condition Name

    Ulcerative Colitis

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