A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Active, not recruiting · Phase 3 · NCT03398135
Conditions: Ulcerative Colitis (UC)
At a glance
- Research payments reported, 2025
- $463,246
- U.S. investigators named
- 36
- Sites paid
- 36
- Planned or actual enrollment
- 1,242
About the trial
- Sponsor
- AbbVie
- Tested
- risankizumab (drug), placebo for risankizumab (drug)
- Dates
- Started 2018-08-28; completion 2029-02
- Results posted
- Not yet
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-…
From ClinicalTrials.gov, last updated 2026-01-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $463,246 in research payments for this study in 2025 (158 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
- Kendall R. Beck Gastroenterology · San Francisco, CA
- Brigid S. Boland, M.D. Gastroenterology · San Diego, CA
- Tarek I. Hassanein, M.D. Hepatology · Coronado, CA
- Gil Y. Melmed, M.D. Gastroenterology · Los Angeles, CA
- Jill K. Gaidos, MD Gastroenterology · New Haven, CT
- Curtis Freedland, D.O. Gastroenterology · New Port Richey, 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
- Charles Berkelhammer, MD Specialist · Oak Lawn, IL
- Saurabh Kapur, MD Gastroenterology · Chicago, IL
- Humberto I. Aguilar, M.D. Gastroenterology · Shreveport, LA
- Vivek R. Huilgol, MD Gastroenterology · New Orleans, LA
- John R. Weber, MD Gastroenterology · Troy, MI
- Edward V. Loftus JR., M.D. Gastroenterology · Rochester, MN
- Nilesh I. Lodhia, MD Gastroenterology · Charlotte, NC
- Hoadley H. Harris, M.D. Family Medicine · Fargo, ND
- Aliza B. Solomon, D.O. Pediatric Gastroenterology · Forest Hills, NY
- Le-chu Su, MD Gastroenterology · New York, NY
- David S. Stokesberry, M.D. Gastroenterology · Oklahoma City, OK
- Faten N. Aberra, MD Gastroenterology · Philadelphia, PA
- Nirav R. Shah, MD, MPH Gastroenterology · Wyomissing, PA
- Matthew R. Barnes, MD Gastroenterology · Greenville, SC
- Robin L. Dalal, M.D. Gastroenterology · Nashville, TN
- Ziad H. Younes, M.D. Gastroenterology · Germantown, TN
- Jeff Bullock, M.D. Gastroenterology · San Antonio, 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
- Harry E. Sarles, M.D. Gastroenterology · Rockwall, TX
- Junaid Siddiqui, MD Gastroenterology · Cedar Park, TX
- Philip Ginsburg, MD Gastroenterology · Rutland, 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
- Cedars-Sinai Medical Center, CA $45,954
- Gastroenterology Associates Of $38,126
- Mayo Clinic Rochester $30,015
- Southern California Research Center $28,994
- Southern Star Research $27,395
- Benaroya Research Institute $26,086
- Avicenna Clinical Research LLC $25,639
- Endoscopic Research Inc $21,856
- Clinical Associates in Research $19,613
- Louisiana Research Center LLC $19,527
- Gastroenterology Center of the Midsouth PLLC DBA Gastro One $17,339
- University of Kansas Medical Center $16,699
- Vanderbilt University Medical Center, TN $16,435
- Texas Digestive Disease $16,113
- Medical Research Center of Connecticut $13,886
- Advanced Research Institute Inc $12,092
- Vilo Research Group Inc $11,476
- Regional Gastroenterology Associates of Lancaster LTD $11,422
- Yale University $9,092
- Hospital of Univ of Pennsylvania, PA $8,580
- Baylor College of Medicine $7,866
- Plains Clinical Research Center LLC $7,310
- Texas Digestive Disease Cons PLLC $6,509
- Weill Medical College of Cornell Universit $5,000
- Gi Pros $4,112
- Regents of the Univ of California $3,974
- Clinical Research Institute Of $2,376
- Carolinas Medical Center-Northeast, NC $2,227
- Digestive Disease Specialists Inc $2,108
- Gastroenterology Associates PA of Greenville $2,000
- Tyler Research Institute LLC $1,701
- The Trustees of Columbia University $861
- Nola Research Works LLC $308
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $241
- Texas Digestive Disease Consultants PA $184
- Cfagi LLC $133
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.