A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
Active, not recruiting · Phase 3 · NCT06063967
Conditions: Crohn's Disease
At a glance
- Research payments reported, 2025
- $3.2M
- U.S. investigators named
- 73
- Sites paid
- 67
- Planned or actual enrollment
- 289
About the trial
- Sponsor
- AbbVie
- Tested
- Risankizumab SC (drug), Placebo for risankizumab (drug)
- Dates
- Started 2023-11-15; completion 2027-03
- Results posted
- Not yet
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants wi…
From ClinicalTrials.gov, last updated 2025-09-09. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $3.2M in research payments for this study in 2025 (578 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
- Chirag D. Trivedi, D.O. Specialist · Sun City, AZ
- Sartaj M. Arora, MD Gastroenterology · West Covina, CA
- Amit Bhanvadia, M.D. Gastroenterology · Anaheim, CA
- Tarek Ezzeddine, MD Internal Medicine · Rancho Cucamonga, CA
- Robert I. Fearn, MBCHB Gastroenterology · Orange, CA
- Neera Grover, MD Gastroenterology · Apple Valley, CA
- Tarek I. Hassanein, M.D. Hepatology · Coronado, CA
- Robert B. Moghimi, M.D. Gastroenterology · Simi Valley, CA
- Thomas Thong H. Nguyen, M.D., Gastroenterology · Victorville, CA
- Jatinder S. Pruthi, M.D. Gastroenterology · Lancaster, CA
- Christine T. Thai, M.D. Rheumatology · Huntington Beach, CA
- Sofia G. Verstraete, M.D. Student in an Organized Health Care Education/Training Program · San Francisco, CA
- Masi Khaja, MD Gastroenterology · Grand Junction, CO
- Adam Gorelick, M.D. Gastroenterology · Danbury, CT
- Ilan Aharoni, M.D. Gastroenterology · Tavares, FL
- Christian M. Andrade, M.D. Gastroenterology · Coral Gables, FL
- Edriss Estime, M.D. Internal Medicine · Clermont, FL
- Roberto D. Fernandez, M.D. Gastroenterology · Hialeah, FL
- Peter H. Gach, MD Gastroenterology · Margate, FL
- Rodolfo Hanabergh, MD Family Medicine · Miami, FL
- Robert J. Hannum, D.O. General Practice · Tampa, FL
- David Kerman, M.D. Gastroenterology · Miami, FL
- Henry Levine, MD Gastroenterology · Orlando, FL
- Andria M. Mushahwar, MD Gastroenterology · Maitland, FL
- Angela K. Pham, M.D. Gastroenterology · Gainesville, FL
- Raymond W. Phillips, M.D. Specialist · Naples, FL
- Vishnu P. Reddy, M. D. Specialist · Ocala, FL
- Alan M. Weintraub, MD Gastroenterology · Tampa, FL
- Melvin D. Bullock, M.D. Gastroenterology · Roswell, GA
- Alan M. Fixelle, M.D. Gastroenterology · Atlanta, GA
- David B. Rausher, M.D. Specialist · Decatur, GA
- Shahriar Sedghi, M.D. Gastroenterology · Macon, GA
- Larry C. Evans, D.O. Gastroenterology · Idaho Falls, ID
- Charles Berkelhammer, MD Specialist · Oak Lawn, IL
- Sushila Dalal Internal Medicine · Chicago, IL
- Saurabh Kapur, MD Gastroenterology · Chicago, IL
- Nina H. Merel, MD Gastroenterology · Glenview, IL
- Jonathan A. Rosenberg, M.D. Gastroenterology · Gurnee, IL
- Monika Fischer, MD Gastroenterology · Indianapolis, IN
- Curtis A. Baum, MD Gastroenterology · Topeka, KS
- Susan Galandiuk, MD Colorectal Surgery · Louisville, KY
- Humberto I. Aguilar, M.D. Gastroenterology · Shreveport, LA
- Hamed Khalili, MD Internal Medicine · Boston, MA
- Allan G. Coates, DO Gastroenterology · Wyoming, MI
- Ronald Fogel, MD Gastroenterology · Chesterfield, MI
- Partha S. Nandi, MD Gastroenterology · Troy, MI
- Edward V. Loftus JR., M.D. Gastroenterology · Rochester, MN
- Laith A. Al Momani, MD Gastroenterology · Kansas City, MO
- Phillip J. Goldstein, M.D. Gastroenterology · Greenville, NC
- Millie D. Long, MD Internal Medicine · Chapel Hill, NC
- Hoadley H. Harris, M.D. Family Medicine · Fargo, ND
- Alexander Brun, MD Gastroenterology · Brooklyn, NY
- Laura E. Frado, M.D. Gastroenterology · New York, NY
- Le-chu Su, MD Gastroenterology · New York, NY
- Adeeti J. Chiplunker, MD Gastroenterology · Hilliard, OH
- Donald L. Mcneil, MD Allergy & Immunology · Columbus, OH
- Tauseef Ali, M.D. Gastroenterology · Oklahoma City, OK
- Harvey A. Tatum, MD Gastroenterology · Tulsa, OK
- Melvyn M. Acosta, M.D. Gastroenterology · Hato Rey, PR
- Stephanie D. Pointer Gastroenterology · Nashville, TN
- Ziad H. Younes, M.D. Gastroenterology · Germantown, TN
- Moheb N. Boktor Gastroenterology · Dallas, TX
- Jeff Bullock, M.D. Gastroenterology · San Antonio, TX
- George A. Duvall, M.D. Gastroenterology · Tyler, TX
- John D. Gabriel, MD Family Medicine · North Richland Hills, TX
- Jason K. Hou, M.D. Gastroenterology · Houston, TX
- Adam T. Hughston, M.D. Gastroenterology · Lubbock, TX
- Moazzam M. Sana, D.O. Internal Medicine · Beaumont, TX
- Harry E. Sarles, M.D. Gastroenterology · Rockwall, TX
- Jignesh P. Shah, MD Gastroenterology · Houston, TX
- Sri Naveen Surapaneni, M.D., M.P.H. Internal Medicine · Webster, TX
- Brian F. Moloney, MB BCH MD Gastroenterology · Milwaukee, WI
- Umapathy Sundaram, M. D. Gastroenterology · Huntington, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Texas Digestive Disease Cons PLLC $285,995
- Om Research LLC $210,009
- Hightower Clinical LLC $200,851
- Indiana University $182,166
- The University of Texas $145,358
- University of North Carolina $144,909
- Novel Research LLC $131,792
- Gastroenterology Center Of $121,416
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $104,071
- Endoscopic Research Inc $93,692
- Mayo Clinic Rochester $91,219
- Dz1lfo Multi Global Conglomerate $87,640
- Novum Research LLC $86,865
- Research Associates of S Flo LLC $76,369
- Adventhealth Orlando, FL $71,569
- Louisiana Research Center LLC $70,773
- Optimed Research LTD $69,514
- Amel Med LLC $66,148
- Linq Research LLC $63,941
- The Ohio State University $60,834
- Carolina Digestive Diseases $55,227
- The Trustees of Columbia University $51,972
- Quality Medical Research PLLC $47,993
- Amicis Research Center $42,205
- Gastroenterology Associates of West $41,133
- Gcp Clinical Research LLC $38,460
- Cotton Oneil Clinic Revocable Trust $33,524
- Clinnova Research Solutions $33,185
- Valley Clinical Trials Inc $31,589
- Jd Medical Group LLC $30,950
- Massachusetts General Hospital, MA $29,454
- St Lukes Hospital of Kansas City, MO $27,300
- University of Miami $26,649
- North Hills Medical Research $26,510
- University of Kansas Medical Center $25,621
- Nuvance Health $23,835
- Univ of Florida Board of Trustees $21,983
- Uci Health-Orange, CA $20,031
- Caribbean Medical Research Center $19,647
- Wisconsin Center for Advanced Resea $19,011
- Clinical Research Institute Of $17,501
- University of Florida $17,106
- Plains Clinical Research Center LLC $16,035
- Ny Scientific Corp $15,613
- Sarkis Clinical Trials $13,203
- Baylor College of Medicine $13,180
- Cfagi LLC $11,300
- Southern California Research Center $11,122
- Prospective Research $9,925
- Avita Clinical Research LLC $9,435
- New York Gastroenterology $9,082
- Gi Pros $8,422
- Atlantic Medical Research LLC $7,716
- University of Louisville $6,812
- Marshall Health (DBA) $6,750
- Grand Teton Research Group PLLC $5,866
- M3 Wake Research Inc $5,800
- Gastroenterology Consultants PC $4,201
- Avicenna Clinical Research LLC $4,115
- Tyler Research Institute LLC $4,050
- Options Health Research LLC $3,715
- Homestead Associates in Research $3,000
- The University of Chicago $2,490
- Newport Huntington Medical Group $2,115
- Southern Star Research $2,115
- Gastroenterology Associates Of $2,115
- Atlanta Center for Gastroenterology $1,039
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.