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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

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

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02435992
Study type Interventional
Source Celgene
Contact
Status Completed
Phase Phase 3
Start date June 17, 2015
Completion date June 17, 2020
View Details
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