Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease (CD)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2028
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT04524611
Start Date
September 30 2020
End Date
February 1 2028
Last Update
August 12 2025
Active Locations (300)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Gastroenterology, P.C /ID# 224396
Chandler, Arizona, United States, 85224-1636
2
Southern California Res. Ctr. /ID# 223484
Coronado, California, United States, 92118-1408
3
Hoag Memorial Hosp Presbyterian /ID# 224373
Irvine, California, United States, 92618
4
United Medical Doctors /ID# 223486
Los Alamitos, California, United States, 90720-3309