A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
ClinicalTrials.gov ID: NCT03398135
Sponsor: AbbVie
Information provided by: AbbVie (Responsible Party)
Last Update Posted: 2023-02-17
Brief 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 or due to the geopolitical conflict in Ukraine and surrounding impacted regions.
OFFICIAL TITLE
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis
INTERVENTION / TREATMENT
Drug: risankizumab
Drug: placebo for risankizumab
| Category | Value |
|---|---|
| Study Start (Actual) | 2018-08-28 |
| Primary Completion (Estimated) | 2024-05-22 |
| Study Completion (Estimated) | 2024-05-22 |
| Enrollment (Actual) | 1242 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
M16-066
2016-004676-22 (EudraCT Number)
|