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A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
Sponsor: AbbVie
Summary
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 be enrolled at 285 sites worldwide. For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study. The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.
Official title: Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
573
Start Date
2025-06-17
Completion Date
2027-08
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
Risankizumab
Intravenous (IV) Infusion
Risankizumab
Subcutaneous (SC) injection
Vedolizumab
Intravenous (IV) infusion
Locations (270)
Gastro Health Research - St. Vincent'S East /ID# 275089
Birmingham, Alabama, United States
Digestive Health Specialists /ID# 274785
Dothan, Alabama, United States
East View Medical Research /ID# 276222
Mobile, Alabama, United States
Arizona Health Research /ID# 274366
Chandler, Arizona, United States
UC San Diego Health System /ID# 273538
La Jolla, California, United States
Gastro Care Institute /ID# 274873
Lancaster, California, United States
UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian /ID# 274364
Newport Beach, California, United States
California Medical Research Associates /ID# 274787
Northridge, California, United States
uc davis medical center - patient support services building /ID# 274251
Sacramento, California, United States
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527
San Diego, California, United States
Danbury Hospital, Western Connecticut Health Network /ID# 275277
Danbury, Connecticut, United States
Novum Research /ID# 273587
Clermont, Florida, United States
Hillcrest Medical Research /ID# 273593
DeLand, Florida, United States
Florida Research Institute /ID# 275196
Lakewood Rch, Florida, United States
Sanchez Clinical Research /ID# 273727
Miami, Florida, United States
Medical Professional Clinical Research /ID# 275208
Miami, Florida, United States
Sarkis Clinical Trials - Ocala /ID# 273595
Ocala, Florida, United States
Endoscopic Research, Inc. /ID# 273548
Orlando, Florida, United States
Digestive And Liver Center Of Florida - Orlando /ID# 276432
Orlando, Florida, United States
Emory University School Of Medicine - Atlanta /ID# 273522
Atlanta, Georgia, United States
Gi Alliance - Glenview /ID# 274270
Glenview, Illinois, United States
Illinois Gastroenterology Group /ID# 274280
Gurnee, Illinois, United States
Southwest Gastroenterology - Oak Lawn /ID# 273596
Oak Lawn, Illinois, United States
OSF St. Francis Medical Center /ID# 274391
Peoria, Illinois, United States
Springfield Clinic Main Campus /ID# 273547
Springfield, Illinois, United States
Gastroenterology Health Partners /ID# 276434
New Albany, Indiana, United States
Iowa Digestive Disease Center - Clive /ID# 274558
Clive, Iowa, United States
Cotton O'Neil Digestive Health Center /ID# 274394
Topeka, Kansas, United States
Gastroenterology Health Partners /ID# 276441
Louisville, Kentucky, United States
Tandem Clinical Research - Houma /ID# 274562
Houma, Louisiana, United States
Metropolitan Gastroenterology Associates - Metairie /ID# 274282
Metairie, Louisiana, United States
Pinnacle Gastroenterology /ID# 274991
Shreveport, Louisiana, United States
Louisiana Research Center, LLC /ID# 276443
Shreveport, Louisiana, United States
Velocity Clinical Research, Rockville /ID# 273599
Rockville, Maryland, United States
Brigham and Womens Hospital /ID# 275266
Boston, Massachusetts, United States
Lucida Clinical Trials /ID# 275235
New Bedford, Massachusetts, United States
Huron Gastroenterology /ID# 274998
Ann Arbor, Michigan, United States
Mayo Clinic-Rochester /ID# 273606
Rochester, Minnesota, United States
Gi Associates - Gia And Endoscopy Center - Flowood /ID# 274285
Flowood, Mississippi, United States
Delta Gastroenterology & Endoscopy Center /ID# 275005
Southaven, Mississippi, United States
Columbia University Medical Center /ID# 273518
New York, New York, United States
New York Gastroenterology Associates - Upper East Side /ID# 273520
New York, New York, United States
Gastroenterology Group of Rochester /ID# 274283
Rochester, New York, United States
Digestive Health Partners - Biltmore Office /ID# 273594
Asheville, North Carolina, United States
Atrium Health - Morehead /ID# 274245
Charlotte, North Carolina, United States
Charlotte Gastroenterology And Hepatology - Randolph Road /ID# 274553
Charlotte, North Carolina, United States
Carolina Digestive Diseases And Endoscopy Center /ID# 274256
Greenville, North Carolina, United States
Dayton Gastroenterology - Beavercreek /ID# 273528
Beavercreek, Ohio, United States
Digestive Disease Consultants - Brunswick /ID# 276445
Brunswick, Ohio, United States
Gastro Health - Cincinnati /ID# 275082
Cincinnati, Ohio, United States
University Of Cincinnati Medical Center /ID# 273524
Cincinnati, Ohio, United States
The Ohio State University /ID# 274743
Columbus, Ohio, United States
Digestive Disease Associates, LTD - Wyomissing /ID# 273603
Wyomissing, Pennsylvania, United States
Gastroenterology Associates of Orangeburg /ID# 274559
Orangeburg, South Carolina, United States
Gastro One - Walnut Run Road /ID# 273551
Cordova, Tennessee, United States
Skyline Gastroenterology of West Tennessee /ID# 276461
Jackson, Tennessee, United States
GI associates of Northeast Tennessee /ID# 273758
Johnson City, Tennessee, United States
Tri-Cities Gastroenterology /ID# 275067
Kingsport, Tennessee, United States
Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 276447
Knoxville, Tennessee, United States
Quality Medical Research /ID# 273733
Nashville, Tennessee, United States
Amel Med /ID# 276439
Georgetown, Texas, United States
Digestive & Liver Disease Consultants /ID# 276454
Houston, Texas, United States
Katy Integrative Gastroenterology /ID# 274645
Katy, Texas, United States
Caprock Gastro Research - Lubbock /ID# 273778
Lubbock, Texas, United States
GI Alliance - Mansfield /ID# 274272
Mansfield, Texas, United States
Linq Research - Pearland /ID# 274917
Pearland, Texas, United States
Tyler Research Institute /ID# 273585
Tyler, Texas, United States
Care Access - Ogden /ID# 274361
Ogden, Utah, United States
Gastroenterology Associates Of Tidewater - Chesapeake /ID# 276440
Chesapeake, Virginia, United States
Emeritas Research Group /ID# 276457
Lansdowne Town Center, Virginia, United States
Gi Alliance - Bellevue /ID# 274264
Bellevue, Washington, United States
Virginia Mason Hospital and Medical Center /ID# 274810
Seattle, Washington, United States
Washington Gastroenterology - Tacoma /ID# 274551
Tacoma, Washington, United States
Medizinische Universitaet Graz /ID# 274428
Graz, Styria, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 274318
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen Gmbh /ID# 274172
Wels, Upper Austria, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 273611
Salzburg, Austria
Medizinische Universitaet Wien /ID# 273612
Vienna, Austria
Hospital Tsaritsa Yoanna /ID# 274723
Sofiya, Sofia, Bulgaria
Umhat Sveti Ivan Rilsky /ID# 274794
Sofiya, Sofia, Bulgaria
Acibadem City Clinic UMHAT Mladost /ID# 274804
Sofiya, Sofia, Bulgaria
Umbal Kaspela /ID# 274721
Plovdiv, Bulgaria
MHAT Knyaginya Klementina /ID# 274722
Sofia, Bulgaria
Mhat Doverie /ID# 274798
Sofia, Bulgaria
University Of Calgary - Health Sciences Centre /ID# 274237
Calgary, Alberta, Canada
Gastroenterology and Internal Medicine Research Institute /ID# 274239
Edmonton, Alberta, Canada
South Edmonton Gastroenterology /ID# 274184
Edmonton, Alberta, Canada
Barrie GI Associates /ID# 275211
Barrie, Ontario, Canada
Brampton Gastroenterology Inc /Id# 276187
Brampton, Ontario, Canada
GNRR Digestive Clinics and Research Center Inc. /ID# 275820
Brampton, Ontario, Canada
The Oakville Endoscopy Centre /ID# 275213
Oakville, Ontario, Canada
Toronto Immune & Digestive Health Institute /ID# 274259
Toronto, Ontario, Canada
Montreal General Hospital /ID# 275201
Montreal, Quebec, Canada
Diex Recherche Quebec Inc. /ID# 274268
Québec, Canada
The First Affiliated Hospital Of Anhui Medical University /ID# 274786
Hefei, Anhui, China
Peking Union Medical College Hospital East - Dongdan Campus /ID# 274886
Beijing, Beijing Municipality, China
Chongqing General Hospital /ID# 274564
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital, Sun-Yat Sen University /ID# 274823
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274843
Guangzhou, Guangdong, China