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
Purpose
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.
Condition
- Crohn's Disease
Eligibility
- Eligible Ages
- Between 16 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit. - Confirmed diagnosis of CD for at least 3 months prior to Baseline. - Crohn's disease activity index (CDAI) score 220 - 450 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, participant must meet the contraception recommendations.
Exclusion Criteria
- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis. - Participants with unstable doses of concomitant Crohn's disease therapy. - Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer. - Prior exposure to p19 inhibitors (e.g., risankizumab). - Complications of Crohn's disease. - Having an ostomy or ileoanal pouch. - Known active Coronavirus Disease 2019 (COVID-19) infection.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Risankizumab Dose 1 (Induction Period 1) |
Participants randomized to receive risankizumab dose 1 in Induction Period 1. |
|
|
Experimental Risankizumab Dose 2 (Induction Period 1) |
Participants randomized to receive risankizumab dose 2 in Induction Period 1. |
|
|
Placebo Comparator Placebo (Induction Period 1) |
Participants randomized to receive placebo for risankizumab in Induction Period 1. |
|
|
Experimental Risankizumab Dose 1 (Induction Period 2) |
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2. |
|
|
Experimental Risankizumab Dose 2 (Induction Period 2) |
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2. |
|
|
Experimental Risankizumab Dose 3 (Induction period 2) |
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2. |
|
More Details
- Status
- Completed
- Sponsor
- AbbVie