Trials / Completed
CompletedNCT03104413
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 618 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 16 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | placebo for risankizumab IV | placebo for risankizumab administered as intravenous (IV) infusion. |
| DRUG | risankizumab SC | risankizumab administered by subcutaneous (SC) injection |
| DRUG | risankizumab IV | risankizumab administered as intravenous (IV) infusion. |
Timeline
- Start date
- 2017-12-18
- Primary completion
- 2020-11-30
- Completion
- 2021-05-19
- First posted
- 2017-04-07
- Last updated
- 2022-06-14
- Results posted
- 2022-06-14
Locations
403 sites across 43 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03104413. Inclusion in this directory is not an endorsement.