Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
Age: 18 - 80 years
Healthy Subjects: No
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: September 23, 2020
End Date: June 06, 2023
- Confirmed diagnosis of Crohn's disease (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 Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
- Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.
- Current diagnosis of ulcerative colitis or indeterminate colitis.
- Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
- Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
- Currently know complications of CD (strictures, short bowel, etc).
- Crohn Disease