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

Condition(s) studied

Investigational drug(s) / intervention(s)

risankizumab: subcutaneous (SC) injection

placebo for risankizumab: subcutaneous (SC) injection

Study 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 and a Continuous Treatment Extension (CTE): 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. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.

Eligibility

Primary outcome measure(s)

• Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score — Week 52
  Clinical remission per Adapted Mayo Score.
• Percentage of Participants with Adverse Events (AE) — Up to Week 300
  An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Trial sites (426)

+ 386 more sites — see the full list on the official registry below.