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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)
Sponsor: AbbVie
Summary
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 enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Official title: A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
527
Start Date
2020-09-30
Completion Date
2028-02
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Risankizumab
Intravenous (IV) Infusion
Risankizumab
Subcutaneous (SC) Injection
Ustekinumab
Intravenous (IV) infusion
Ustekinumab
Subcutaneous (SC) injection
Locations (300)
Advanced Gastroenterology, P.C /ID# 224396
Chandler, Arizona, United States
Southern California Res. Ctr. /ID# 223484
Coronado, California, United States
Hoag Memorial Hosp Presbyterian /ID# 224373
Irvine, California, United States
United Medical Doctors /ID# 223486
Los Alamitos, California, United States
TLC Clinical Research Inc /ID# 223467
Los Angeles, California, United States
Duplicate_UC Davis Medical Center /ID# 225700
Sacramento, California, United States
Duplicate_University of California, San Francisco /ID# 223621
San Francisco, California, United States
Duplicate_Western Connecticut Medical Group /ID# 223478
Danbury, Connecticut, United States
Duplicate_Medical Research Center of CT /ID# 223540
Hamden, Connecticut, United States
Yale Univ Digestive Diseases /ID# 224463
New Haven, Connecticut, United States
Omega Research Maitland, LLC /ID# 223463
DeBary, Florida, United States
Nature Coast Clinical Research - Inverness /ID# 223600
Inverness, Florida, United States
University of Miami /ID# 223496
Miami, Florida, United States
Gastroenterology Group Naples /ID# 223516
Naples, Florida, United States
Advanced Research Institute, Inc /ID# 223470
New Port Richey, Florida, United States
Endoscopic Research, Inc. /ID# 223505
Orlando, Florida, United States
Duplicate_University of South Florida /ID# 224733
Tampa, Florida, United States
Atlanta Gastro Assoc /ID# 223537
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 223525
Macon, Georgia, United States
Duplicate_The University of Chicago DCAM /ID# 223520
Chicago, Illinois, United States
NorthShore University-Endeavor Health Evanston Hospital /ID# 223538
Evanston, Illinois, United States
Southwest Gastroenterology /ID# 223509
Oak Lawn, Illinois, United States
University of Louisville Hospital /ID# 223471
Louisville, Kentucky, United States
GI Alliance /ID# 223508
Baton Rouge, Louisiana, United States
Nola Research Works, LLC /ID# 223489
New Orleans, Louisiana, United States
Louisiana Research Center, LLC /ID# 223503
Shreveport, Louisiana, United States
Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499
Chevy Chase, Maryland, United States
Gastro Center of Maryland /ID# 223518
Columbia, Maryland, United States
Massachusetts General Hospital /Id# 224335
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 228094
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597
Ann Arbor, Michigan, United States
AA Medical Research Center - Flint /ID# 224384
Flint, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465
Wyoming, Michigan, United States
Mayo Clinic - Rochester /ID# 223506
Rochester, Minnesota, United States
Las Vegas Medical Research /ID# 223533
Las Vegas, Nevada, United States
Univ New Mexico /ID# 223515
Albuquerque, New Mexico, United States
NY Scientific /ID# 223479
Brooklyn, New York, United States
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048
Burnt Hills, New York, United States
Intercity Advanced Gastroentertology Center /ID# 224313
Fresh Meadows, New York, United States
North Shore University Hospital /ID# 224356
New Hyde Park, New York, United States
The Mount Sinai Hospital /ID# 223687
New York, New York, United States
Columbia Univ Medical Center /ID# 224215
New York, New York, United States
Lenox Hill Hospital /ID# 223534
New York, New York, United States
Univ NC Chapel Hill /ID# 224405
Chapel Hill, North Carolina, United States
Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 224406
Winston-Salem, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 223522
Fargo, North Dakota, United States
University of Cincinnati Medical Center /ID# 224614
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus /ID# 223691
Cleveland, Ohio, United States
DSI Research, LLC /ID# 234116
Springboro, Ohio, United States
Hightower Clinical /ID# 223566
Oklahoma City, Oklahoma, United States
Digestive Disease Specialists /ID# 223528
Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center /ID# 224216
Hershey, Pennsylvania, United States
Guthrie Medical Group, PC /ID# 223910
Sayre, Pennsylvania, United States
Digestive Disease Associates, LTD - Wyomissing /ID# 223462
Wyomissing, Pennsylvania, United States
Medical University of South Carolina /ID# 223485
Charleston, South Carolina, United States
Consultants in Gastroenterology - Columbia NE /ID# 224263
Columbia, South Carolina, United States
Gastroenterology Associates, P.A. of Greenville /ID# 223497
Greenville, South Carolina, United States
Gastro One /ID# 223539
Cordova, Tennessee, United States
Vanderbilt University Medical Center /ID# 224610
Nashville, Tennessee, United States
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512
Dallas, Texas, United States
Duplicate_DHAT Research Institute /ID# 223521
Garland, Texas, United States
Vilo Research Group Inc /ID# 223513
Houston, Texas, United States
Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 223488
Houston, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 223510
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 223598
San Antonio, Texas, United States
Texas Digestive Disease Consultants - Southlake /ID# 224264
Southlake, Texas, United States
Tyler Research Institute, LLC /ID# 223469
Tyler, Texas, United States
University of Vermont Medical Center /ID# 224047
Burlington, Vermont, United States
Richmond VA Medical Center /ID# 223586
Richmond, Virginia, United States
Virginia Mason Hospital & Medical Center /ID# 224253
Seattle, Washington, United States
Harborview Medical Center /ID# 224464
Seattle, Washington, United States
West Virginia University Hospitals /ID# 223501
Morgantown, West Virginia, United States
Hospital Britanico de Buenos Aires /ID# 223432
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires /ID# 224550
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina
CINME Centro de Investigaciones Metabolicas /ID# 223447
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Gedyt /ID# 224698
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Duplicate_CEMIC /ID# 223670
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Duplicate_Sanatorio 9 de Julio /ID# 226086
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 223433
Córdoba, Argentina
Wollongong Hospital /ID# 224688
Wollongong, New South Wales, Australia
Mater Misericordiae Limited /ID# 223642
South Brisbane, Queensland, Australia
Griffith University /ID# 223641
Southport, Queensland, Australia
Lyell McEwin Hospital /ID# 223643
Elizabeth Vale, South Australia, Australia
Monash Health - Monash Medical Centre /ID# 224599
Clayton, Victoria, Australia
Universitaetsklinikum St. Poelten /ID# 223437
Sankt Pölten, Lower Austria, Austria
Medizinische Universitaet Wien /ID# 223438
Vienna, State of Vienna, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440
Linz, Upper Austria, Austria
ZAS Palfijn /ID# 223907
Merksem, Antwerpen, Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 223902
Anderlecht, Brussels Capital, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 223900
Brussels, Brussels Capital, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 223898
Liège, Liege, Belgium
Duplicate_CHU UCL Namur - site Godinne /ID# 223905
Godinne, Namur, Belgium
UZ Gent /ID# 223899
Ghent, Oost-Vlaanderen, Belgium
Vitaz /Id# 224511
Sint-Niklaas, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 223901
Leuven, Vlaams-Brabant, Belgium
AZ-Delta. /ID# 223896
Roeselare, West-Vlaanderen, Belgium
AZ Maria Middelares /ID# 223908
Ghent, Belgium
Duplicate_CHU de Liege /ID# 223904
Liège, Belgium
Faculdade de Medicina do ABC /ID# 223231
Santo André, La Spezia, Brazil
Upeclin Fmb - Unesp /Id# 223234
Botucatu, São Paulo, Brazil