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)
Active, not recruiting · Phase 3 · NCT04524611
Conditions: Crohn's Disease (CD)
At a glance
- Research payments reported, 2025
- $235,945
- U.S. investigators named
- 17
- Sites paid
- 17
- Planned or actual enrollment
- 527
About the trial
- Sponsor
- AbbVie
- Tested
- Risankizumab (drug), Risankizumab (drug), Ustekinumab (drug), Ustekinumab (drug)
- Dates
- Started 2020-09-30; completion 2028-02
- Results posted
- Not yet
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 assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolle…
From ClinicalTrials.gov, last updated 2026-04-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $235,945 in research payments for this study in 2025 (48 payments).
Products named: Skyrizi
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Caroline Hwang, M.D. Gastroenterology · Los Angeles, CA
- Badr F. Al Bawardy, MD Gastroenterology · New Haven, CT
- Paul A. Hellstern, M.D. Gastroenterology · Crystal River, FL
- Jason A. Korenblit, M.D. Gastroenterology · Orlando, FL
- Shahriar Sedghi, M.D. Gastroenterology · Macon, GA
- Ioannis Economou, M.D. Gastroenterology · Glenview, IL
- Susan Galandiuk, MD Colorectal Surgery · Louisville, KY
- Edward V. Loftus JR., M.D. Gastroenterology · Rochester, MN
- Joel F. Schock IV, M.D. Family Medicine · Fargo, ND
- Arun Swaminath, M.D. Gastroenterology · New York, NY
- Loren P. Brook, M.D. Gastroenterology · Cincinnati, OH
- Ziad H. Younes, M.D. Gastroenterology · Germantown, TN
- George A. Duvall, M.D. Gastroenterology · Tyler, TX
- Timothy E. Ritter, M.D. Gastroenterology · Southlake, TX
- William M. Pandak JR., M.D. Gastroenterology · Richmond, VA
- Jason D. Heffley, M.D. M.P.H. Gastroenterology · Burlington, VT
- Timothy L. Zisman, MD, MPH Gastroenterology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Gastroenterology Center of the Midsouth $83,970
- Mayo Clinic $49,685
- Tyler Research Institute LLC $18,074
- Richmond VA Medical Center (151) $13,901
- Gastroenterology Associates of Central Georgia LLC $13,180
- Feinstein Institute for Medical Research $11,479
- Texas Digestive Disease Consultants PLLC $11,068
- Benaroya Research Institute at Virginia Mason $8,107
- UC Healthcare System $5,653
- Plains Clinical Research Center LLC $4,169
- Northshore University Healthsystem - Evanston Hospital, IL $4,141
- Nature Coast Clinical Research LLC $2,817
- Univ. of Vermont - Fletcher Allen Health Care, VT $2,500
- Endoscopic Research Inc $2,500
- University of Louisville $2,219
- Hoag Memorial Presbyterian Hospital $1,452
- Yale University $1,030
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.