Overview

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Status:
Enrolling by invitation
Trial end date:
2024-05-23
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic.
Phase:
Phase 3
Details
Lead Sponsor:
AbbVie
Treatments:
Antibodies, Monoclonal