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
NCT03104413 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 618
Last updated 2022-06-14
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
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ABBVIE INC. · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-18
- Primary Completion
- 2020-11-30
- Completion
- 2021-05-19
- FDA Drug
- Yes
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
Study Locations
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