Ulcerative colitis: Study on the efficacy and safety of risankizumab

ClinicalTrials.gov ID: NCT03398135
Sponsor: AbbVie Information provided by: AbbVie (responsible party)

Official title:
Multicenter, randomized, double-blind, placebo-controlled 52-week maintenance study with open-label long-term extension to evaluate the efficacy and safety of risankizumab in patients with ulcerative colitis.

Study overview:
The aim is to evaluate the safety and efficacy of risankizumab in patients with ulcerative colitis who have responded to induction therapy with risankizumab in a previous AbbVie study.

The study consists of three sub-studies and a continuous treatment extension (CTE):

• Sub-study 1: 52-week, randomized, double-blind, placebo-controlled maintenance study
• Sub-study 2: 52-week, randomized, exploratory maintenance study
• Sub-study 3: Open-label long-term extension study for participants who have completed sub-study 1 or 2 or who have responded to induction therapy in study M16-067 but were unable to receive a final endoscopy due to COVID-19 or geopolitical conflicts (Ukraine and affected regions)

The CTE serves to ensure continuous treatment with risankizumab until the drug is commercially available or can be obtained locally.