A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Active, not recruiting · Phase 3 · NCT03105102
Conditions: Crohn's Disease
At a glance
- Research payments reported, 2025
- $694,001
- U.S. investigators named
- 37
- Sites paid
- 38
- Planned or actual enrollment
- 1,336
About the trial
- Sponsor
- AbbVie
- Tested
- Placebo for Risankizumab SC (drug), Risankizumab IV (drug), Placebo for Risankizumab IV (drug), Risankizumab SC (drug), Risankizumab On-Body Injector (OBI) (drug)
- Dates
- Started 2018-04-09; completion 2029-02
- Results posted
- Not yet
The study consists of 4 sub-studies, as follows: * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; * Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; * Sub-study 3 (Open-label, long-term extension study) to evaluate l…
From ClinicalTrials.gov, last updated 2026-08-14. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $694,001 in research payments for this study in 2025 (132 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
- Melvin B. Heyman, M.D. Pediatrics · San Francisco, CA
- Bhaktasharan C. Patel, MD Gastroenterology · Colorado Springs, CO
- Leonard J. Dunn, MD Pulmonology · Dunedin, FL
- Paul A. Hellstern, M.D. Gastroenterology · Crystal River, FL
- Henry Levine, MD Gastroenterology · Orlando, FL
- Andria M. Mushahwar, MD Gastroenterology · Maitland, FL
- Raymond W. Phillips, M.D. Specialist · Naples, FL
- Shahriar Sedghi, M.D. Gastroenterology · Macon, GA
- Douglas C. Wolf, MD Gastroenterology · Atlanta, GA
- Charles Berkelhammer, MD Specialist · Oak Lawn, IL
- Sushila Dalal Internal Medicine · Chicago, IL
- Ioannis Economou, M.D. Gastroenterology · Glenview, IL
- Curtis A. Baum, MD Gastroenterology · Topeka, KS
- Susan Galandiuk, MD Colorectal Surgery · Louisville, KY
- Vivek R. Huilgol, MD Gastroenterology · New Orleans, LA
- Louis Y. Korman, M.D. Gastroenterology · Chevy Chase, MD
- Allan G. Coates, DO Gastroenterology · Wyoming, MI
- Peter D. Higgins, MD, PHD Gastroenterology · Ann Arbor, MI
- Edward V. Loftus JR., M.D. Gastroenterology · Rochester, MN
- Hoadley H. Harris, M.D. Family Medicine · Fargo, ND
- Christian D. Stone, MD, MPH Gastroenterology · Las Vegas, NV
- Adeeti J. Chiplunker, MD Gastroenterology · Hilliard, OH
- Donald L. Mcneil, MD Allergy & Immunology · Columbus, OH
- David S. Stokesberry, M.D. Gastroenterology · Oklahoma City, OK
- John F. Altomare, M.D. Gastroenterology · Wyomissing, PA
- Erin M. Forster, M.D. Gastroenterology · Charleston, SC
- Baldeep S. Pabla, M.D. Gastroenterology · Nashville, TN
- Chakradhar M. Reddy, M.D Gastroenterology · Johnson City, TN
- Lisa S. Usdan, M.D. Endocrinology & Diabetes · Memphis, TN
- Themistocles Dassopoulos, MD Gastroenterology · Dallas, TX
- George A. Duvall, M.D. Gastroenterology · Tyler, TX
- Jason K. Hou, M.D. Gastroenterology · Houston, TX
- Nikhil V. Inamdar, M.D. Gastroenterology · Houston, TX
- Jaime L. Mayoral, MD Colorectal Surgery · San Antonio, TX
- Harry S. Ojeas, MD Gastroenterology · Houston, TX
- William M. Pandak JR., M.D. Gastroenterology · Richmond, VA
- Justin T. Kupec, MD Gastroenterology · Morgantown, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Aga LLC $102,638
- Tyler Research Institute LLC $76,819
- Gastroenterology Associates Of $72,692
- Nature Coast Clinical Research $53,521
- Peak Gastroenterology Associates Inc $39,977
- Cotton O Neil Clinical Research Center $35,045
- University of Louisville Research Foundation $23,803
- Mayo Clinic Rochester $20,505
- Vilo Research Group Inc $20,331
- Gi Pros $18,962
- Vanderbilt University Medical Center, TN $16,539
- Gastroenterology Associates of Western Michigan PLC $16,084
- Clinical Associates in Research Therapeutics of America LLC $16,045
- University of Michigan Health System, MI $13,427
- Cfagi LLC $12,376
- Optimed Research LTD $12,203
- Digestive Disease Specialists $10,956
- Baylor College of Medicine $10,901
- Clinical Research of West Florida $10,723
- University of Chicago $10,661
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $10,298
- Avicenna Clinical Research LLC $10,220
- Endoscopic Research Inc $10,174
- Clinical Neuroscience Solutions Inc $10,160
- Nola Research Works LLC $9,987
- West Virginia University $8,710
- Mcguire Research Institute Inc $8,696
- Plains Clinical Research Center LLC $7,784
- Medical University South Carolina $7,342
- Interspond LLC $6,224
- Ohio State University $2,111
- Baylor Scott & White Research Institute $1,844
- Metropolitan Gastroenterology Group $1,514
- Center for Digestive Health $1,140
- Northshore University Healthsystem - Evanston Hospital, IL $1,045
- Texas Digestive Disease Consultants PA $919
- Las Vegas Medical Research LLC $871
- East Tennessee Research Institute LLC $756
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.