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

Clinical Trial ID: NCT02531126

Description

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.

The trial is an open label extension study. Eligible patients from the RPC01-3101 and RPC01-202 trials will have the option to enroll in this trial to receive study medication until the end of 2021 or until marketing approval of RPC1063 for UC is obtained in their country, or until the Sponsor discontinues the development program, whichever comes first.


Criteria

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

  • Start Date

    2015-12-02

  • Last Updated

    2020-02-25

  • Sponsor

    Celgene

  • Condition Name

    Ulcerative Colitis

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