NCT02531126

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 877 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.

Detailed description

This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	RPC1063

Timeline

• Start date: 2015-12-02
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2015-08-24
• Last updated: 2025-12-31
• Results posted: 2025-12-31

Locations

41 sites across 20 countries: United States, Australia, Belarus, Belgium, Bulgaria, Canada, Croatia, Czechia, Germany, Greece, Hungary, Israel, Italy, Moldova, Poland, Romania, Slovakia, South Korea, Ukraine, United Kingdom