Trials / Completed
CompletedNCT03105128
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 931 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 16 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | placebo for risankizumab | Placebo for risankizumab administered by intravenous infusion |
| DRUG | risankizumab IV | Risankizumab administered by intravenous infusion |
| DRUG | risankizumab SC | Risankizumab administered by subcutaneous (SC) injection |
Timeline
- Start date
- 2017-05-10
- Primary completion
- 2020-11-09
- Completion
- 2021-04-14
- First posted
- 2017-04-07
- Last updated
- 2022-07-06
- Results posted
- 2022-07-06
Locations
475 sites across 44 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, 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, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03105128. Inclusion in this directory is not an endorsement.