A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

  • STATUS
    Recruiting
  • sponsor
    Celgene
Updated on 25 March 2021

Summary

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

Description

The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in clinical response at the end of the Induction Period will proceed through to the Maintenance Period. Participation in these periods will be 52 weeks. Patients may also qualify to participate in an optional Open-Label Extension study.

Details
Condition Ulcerative Colitis
Clinical Study IdentifierTX153763
SponsorCelgene
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Ulcerative Colitis (UC) confirmed on endoscopy
Moderately to severely active UC (Mayo score 6-12)
Currently receiving treatment with aminosalisylate, prednisone, or budesonide

Exclusion Criteria

Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or 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 macular edema
Pregnancy, lactation, or a positive serum ß-human chorionic gonadotropin (ß-hCG) measured during Screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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