A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
Active, not recruiting · Phase 3 · NCT06880744
Conditions: Ulcerative Colitis
At a glance
- Research payments reported, 2025
- $1.6M
- U.S. investigators named
- 66
- Sites paid
- 55
- Planned or actual enrollment
- 573
About the trial
- Sponsor
- AbbVie
- Tested
- Risankizumab (drug), Risankizumab (drug), Vedolizumab (drug)
- Dates
- Started 2025-06-17; completion 2027-08
- Results posted
- Not yet
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs). Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will …
From ClinicalTrials.gov, last updated 2026-08-04. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $1.6M in research payments for this study in 2025 (191 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
- Travis J. Rutland, MD Gastroenterology · Dothan, AL
- Robert A. Shaffer, M.D. Gastroenterology · Birmingham, AL
- Jonathan D. Siegel, MD Specialist · Mobile, AL
- Jae H. Kim, M.D. Gastroenterology · Mesa, AZ
- Calin S. Arimie, MD Gastroenterology · West Hills, CA
- Caroline Hwang, M.D. Gastroenterology · Los Angeles, CA
- Sherif Michael Gastroenterology · Santa Barbara, CA
- Vijayalakshmi S. Pratha, MD Gastroenterology · San Diego, CA
- Duminda B. Suraweera, M.D. Gastroenterology · Lancaster, CA
- Masi Khaja, MD Gastroenterology · Grand Junction, CO
- Adam Gorelick, M.D. Gastroenterology · Danbury, CT
- Belen A. Tesfaye, M.D Gastroenterology · Washington, DC
- Edriss Estime, M.D. Internal Medicine · Clermont, FL
- John M. Hill, MD Family Medicine · Deland, FL
- Henry Levine, MD Gastroenterology · Orlando, FL
- Vishnu P. Reddy, M. D. Specialist · Ocala, FL
- Manuel B. Rodriguez SR., MD Family Medicine · Miami, FL
- Mirel Sanchez, M.D. Family Medicine · Miami, FL
- Carlos A. Selema, MD Gastroenterology · Coral Gables, FL
- Harinath Sheela, MD Gastroenterology · Orlando, FL
- Heba N. Iskandar, M.D. Gastroenterology · Atlanta, GA
- Bernard I. Leman, MD Gastroenterology · Clive, IA
- Charles Berkelhammer, MD Specialist · Oak Lawn, IL
- Joseph W. Franses, MD Medical Oncology · Chicago, IL
- Nikhil R. Kalva, M.D Gastroenterology · Peoria, IL
- Nina H. Merel, MD Gastroenterology · Glenview, IL
- Jonathan A. Rosenberg, M.D. Gastroenterology · Gurnee, IL
- Dmitry Shuster, M.D. Gastroenterology · Springfield, IL
- Jonathan Obert, MD Gastroenterology · New Albany, IN
- Curtis A. Baum, MD Gastroenterology · Topeka, KS
- Michael P. Krease, D.O. Gastroenterology · Louisville, KY
- Humberto I. Aguilar, M.D. Gastroenterology · Shreveport, LA
- George E. Catinis, M.D. Gastroenterology · Metairie, LA
- Conar P. Fitton, M.D. Gastroenterology · Kenner, LA
- Jessica R. Allegretti, M.D. Gastroenterology · Boston, MA
- Jason S. Reich, MD Gastroenterology · Fall River, MA
- Edward V. Loftus JR., M.D. Gastroenterology · Rochester, MN
- Ulric D. Duncan, M.D. Specialist · Southaven, MS
- Ernest S. Weeks JR., M.D. Gastroenterology · Flowood, MS
- Phillip J. Goldstein, M.D. Gastroenterology · Greenville, NC
- William R. Harlan III, M.D. Gastroenterology · Asheville, NC
- Nilesh I. Lodhia, MD Gastroenterology · Charlotte, NC
- Laura E. Frado, M.D. Gastroenterology · New York, NY
- Jonathan I. Goldstein, M.D. Gastroenterology · Rochester, NY
- Loren P. Brook, M.D. Gastroenterology · Cincinnati, OH
- Adeeti J. Chiplunker, MD Gastroenterology · Hilliard, OH
- Rupa Fritz, M.D. Gastroenterology · Dayton, OH
- Steven R. Gay, M.D. Internal Medicine · Cincinnati, OH
- Nirav R. Shah, MD, MPH Gastroenterology · Wyomissing, PA
- Melvyn M. Acosta, M.D. Gastroenterology · Hato Rey, PR
- Melvin Melendez, M.D. Gastroenterology · San Juan, PR
- Jose J. Munoz Acaba, MD Gastroenterology · San Juan, PR
- Narayanachar S. Murali, M.D. Gastroenterology · Orangeburg, SC
- William F. Ergen, M.D. Gastroenterology · Knoxville, TN
- Brittain D. Little, M.D. Gastroenterology · Jackson, TN
- Stephanie D. Pointer Gastroenterology · Nashville, TN
- Ziad H. Younes, M.D. Gastroenterology · Germantown, TN
- Houssam Al Kharrat, MD Gastroenterology · Lubbock, TX
- Gregory Brennan, M.D. Gastroenterology · Mansfield, TX
- George A. Duvall, M.D. Gastroenterology · Tyler, TX
- Howard Hamat, MD Gastroenterology · Houston, TX
- Jignesh P. Shah, MD Gastroenterology · Houston, TX
- Radha A. Tamerisa, M.D. Gastroenterology · Katy, TX
- Chad M. Gonzales, M.D. Gastroenterology · Ogden, UT
- William H. Holderman, M.D. Gastroenterology · Tacoma, WA
- Nicholas J. Procaccini, MD Gastroenterology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Texas Digestive Disease Cons PLLC $175,500
- Springfield Clinic LLP $91,733
- Gastro Care LLP $55,881
- University of Cincinnati $52,058
- Cotton Oneil Clinic Revocable Trust $51,866
- Gcga Physicians LLC $49,014
- Amel Med LLC $42,553
- Willis Knighton Medical Center, LA $42,487
- Novum Research LLC $40,393
- Gastroenterology Health PArtners $39,152
- Tyler Research Institute LLC $38,939
- Gastroenterology Center Of $36,563
- The Ohio State University $34,781
- Mayo Clinic $33,260
- Emory University Hospital, GA $31,889
- Avicenna Clinical Research LLC $28,321
- Candun Research Institute Inc $27,750
- Gastro Assc of Orangeburg PA $26,850
- Linq Research LLC $26,650
- Endoscopic Research Inc $26,526
- Clinical Applications Laboratories $26,229
- Florida Digestive Health $25,713
- Dayton Gastroenterology LLC $25,397
- Nuvance Health $25,355
- Caribbean Medical Research Center $24,747
- Isis Clinical Research Center $24,000
- Integrity Advanced Therapeutics $22,702
- Fundacion De Investigacion De Diego $22,500
- New York Gastroenterology $21,646
- East View Medical Research LLC $21,000
- Care Access Research LLC $20,750
- Quality Medical Research PLLC $20,500
- Velocity Clinical Research Inc $20,000
- Digestive and Liver Center $19,850
- Osf Little Company of Mary Medical Center, IL $19,000
- Louisiana Research Center LLC $17,850
- Gia Clinical Trials LLC $17,850
- Caprock Gastro Research LLC $17,850
- The Ehs Medical Practice PA $17,600
- Lucida Clinical Trials $17,500
- Digestive Health PArtners PA $17,345
- Hoag Memorial Hospital Presbyterian $17,292
- Usdh Clinical Research LLC $17,042
- Tandem Intermediate LLC $16,550
- Az Gastro Care $15,950
- Gut PC $14,900
- Brigham and Women's Hospital, MA $14,900
- Vitality Digestive Institute $14,599
- Sanchez Clinical Research Inc $13,756
- Hillcrest Medical Research LLC $13,636
- Atrium Health Foundation $12,500
- Medical Professional Clinical $11,037
- Carolina Research $11,037
- California Medical Research Associa $11,037
- Heartland Medical Research Inc $11,037
- $8,745
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.