NCT03105102

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

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 Crohn's Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,336 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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. * OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Placebo for Risankizumab SC	Placebo for Risankizumab SC Subcutaneous (SC) Injection
DRUG	Risankizumab IV	Risankizumab IV Intravenous (IV) infusion
DRUG	Placebo for Risankizumab IV	Placebo for Risankizumab IV Intravenous (IV) infusion
DRUG	Risankizumab SC	Risankizumab SC Subcutaneous (SC) injection
DRUG	Risankizumab On-Body Injector (OBI)	Subcutaneous (SC) injection; on-body injector (OBI)

Timeline

• Start date: 2018-04-09
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2017-04-07
• Last updated: 2025-08-14

Locations

496 sites across 47 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study