A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Status:
Active, not recruiting
Trial end date:
2026-06-09
Target enrollment:
Participant gender:
Summary
The study consists of 4 sub-studies, as follows:
- Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the
efficacy and safety of risankizumab versus placebo as maintenance therapy in
participants with moderately to severely active Crohn's disease (CD) who responded to
intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
- Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and
safety of two different dosing regimens for risankizumab as maintenance therapy in
participants who responded to induction treatment in Study M16-006 or Study M15-991;
- Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of
risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie
risankizumab Crohn's disease study, or participants who responded to induction treatment
in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.
Additional objectives are to further investigate long-term efficacy and tolerability of
risankizumab;
- Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension
study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and
pharmacokinetics of risankizumab administered via OBI in participants who are receiving
maintenance treatment with risankizumab.