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

The trial is an open label extension study. Eligible patients from the RPC01-3101 and RPC01-202 trials were able to roll-over 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.

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

This is an open-label, multicenter, extension trial to evaluate the long-term safety and efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC). The purpose of this extension trial is to evaluate the long-term safety and efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC). Only those patients 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

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

Recruitment

Summary

Participation Requirements

Description

Tracking Information