NCT02435992

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

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,012 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	RPC1063
DRUG	Placebo

Timeline

• Start date: 2015-06-17
• Primary completion: 2020-03-27
• Completion: 2020-06-17
• First posted: 2015-05-06
• Last updated: 2021-09-01
• Results posted: 2021-09-01

Locations

372 sites across 30 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Croatia, Czechia, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Moldova, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Ukraine, United Kingdom