A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.
- Conditions
- Crohn's diseaseMedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-003190-17-DK
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 579
- Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
- Diagnosis of CD for at least 3 months prior to Baseline
- Crohn's disease activity index (CDAI) score at Baseline
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
- Demonstrated intolerance or inadequate response to biologic therapy for CD
- If female, subject must meet the contraception recommendations
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 543
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
- Subjects with unstable doses of concomitant Crohn's disease therapy
- Receipt of Crohn's disease approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
- Prior exposure to p19 inhibitors (e.g.,risankizumab)
- Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.;Secondary Objective: Not applicable.;Primary end point(s): Co-Primary Endpoints: <br>Proportion of subjects with clinical remission at Week 12 <br>Proportion of subjects with endoscopic response at Week 12 ;Timepoint(s) of evaluation of this end point: Week 12<br>Week 12
- Secondary Outcome Measures
Name Time Method