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)
Run by AbbVie · NCT04524611 · Data updated 2026-11-12
Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2028-02.
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 assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be…
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 527 (actual) |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | Risankizumab, Risankizumab, Ustekinumab, Ustekinumab |
| Locations | 300 sites (Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile and more) |
| Trial ID | NCT04524611 on ClinicalTrials.gov |
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where it's running
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Advanced Gastroenterology, P.C /ID# 224396
Chandler, Arizona, United States -
Southern California Res. Ctr. /ID# 223484
Coronado, California, United States -
Hoag Memorial Hosp Presbyterian /ID# 224373
Irvine, California, United States -
United Medical Doctors /ID# 223486
Los Alamitos, California, United States -
TLC Clinical Research Inc /ID# 223467
Los Angeles, California, United States -
Duplicate_UC Davis Medical Center /ID# 225700
Sacramento, California, United States
Show 44 more locations
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Duplicate_University of California, San Francisco /ID# 223621
San Francisco, California, United States -
Duplicate_Western Connecticut Medical Group /ID# 223478
Danbury, Connecticut, United States -
Duplicate_Medical Research Center of CT /ID# 223540
Hamden, Connecticut, United States -
Yale Univ Digestive Diseases /ID# 224463
New Haven, Connecticut, United States -
Omega Research Maitland, LLC /ID# 223463
DeBary, Florida, United States -
Nature Coast Clinical Research - Inverness /ID# 223600
Inverness, Florida, United States -
University of Miami /ID# 223496
Miami, Florida, United States -
Gastroenterology Group Naples /ID# 223516
Naples, Florida, United States -
Advanced Research Institute, Inc /ID# 223470
New Port Richey, Florida, United States -
Endoscopic Research, Inc. /ID# 223505
Orlando, Florida, United States -
Duplicate_University of South Florida /ID# 224733
Tampa, Florida, United States -
Atlanta Gastro Assoc /ID# 223537
Atlanta, Georgia, United States -
Gastroenterology Associates of Central Georgia, LLC /ID# 223525
Macon, Georgia, United States -
Duplicate_The University of Chicago DCAM /ID# 223520
Chicago, Illinois, United States -
NorthShore University-Endeavor Health Evanston Hospital /ID# 223538
Evanston, Illinois, United States -
Southwest Gastroenterology /ID# 223509
Oak Lawn, Illinois, United States -
University of Louisville Hospital /ID# 223471
Louisville, Kentucky, United States -
GI Alliance /ID# 223508
Baton Rouge, Louisiana, United States -
Nola Research Works, LLC /ID# 223489
New Orleans, Louisiana, United States -
Louisiana Research Center, LLC /ID# 223503
Shreveport, Louisiana, United States -
Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499
Chevy Chase, Maryland, United States -
Gastro Center of Maryland /ID# 223518
Columbia, Maryland, United States -
Massachusetts General Hospital /Id# 224335
Boston, Massachusetts, United States -
Beth Israel Deaconess Medical Center /ID# 228094
Boston, Massachusetts, United States -
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597
Ann Arbor, Michigan, United States -
AA Medical Research Center - Flint /ID# 224384
Flint, Michigan, United States -
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465
Wyoming, Michigan, United States -
Mayo Clinic - Rochester /ID# 223506
Rochester, Minnesota, United States -
Las Vegas Medical Research /ID# 223533
Las Vegas, Nevada, United States -
Univ New Mexico /ID# 223515
Albuquerque, New Mexico, United States -
NY Scientific /ID# 223479
Brooklyn, New York, United States -
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048
Burnt Hills, New York, United States -
Intercity Advanced Gastroentertology Center /ID# 224313
Fresh Meadows, New York, United States -
North Shore University Hospital /ID# 224356
New Hyde Park, New York, United States -
The Mount Sinai Hospital /ID# 223687
New York, New York, United States -
Columbia Univ Medical Center /ID# 224215
New York, New York, United States -
Lenox Hill Hospital /ID# 223534
New York, New York, United States -
Univ NC Chapel Hill /ID# 224405
Chapel Hill, North Carolina, United States -
Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 224406
Winston-Salem, North Carolina, United States -
Plains Clinical Research Center, LLC /ID# 223522
Fargo, North Dakota, United States -
University of Cincinnati Medical Center /ID# 224614
Cincinnati, Ohio, United States -
Cleveland Clinic Main Campus /ID# 223691
Cleveland, Ohio, United States -
DSI Research, LLC /ID# 234116
Springboro, Ohio, United States -
Hightower Clinical /ID# 223566
Oklahoma City, Oklahoma, United States
+250 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Abbvie INC. — AbbVie
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.