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Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
Sponsor: AbbVie
Summary
Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC). This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. 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, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Official title: A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2026-07-31
Completion Date
2031-10
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Locations (64)
Digestive Health Specialists /ID# 280827
Dothan, Alabama, United States
Elite Clinical Studies /ID# 280477
Phoenix, Arizona, United States
Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
Sun City, Arizona, United States
Clinnova Research /ID# 280509
Anaheim, California, United States
Southern California Res. Ctr /ID# 280476
Coronado, California, United States
Gastro Care Institute /ID# 281071
Lancaster, California, United States
United Medical Doctors - Los Alamitos /ID# 281125
Los Alamitos, California, United States
Inland Empire Liver Foundation - Rialto /ID# 280775
Rialto, California, United States
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
Colorado Springs, Colorado, United States
Synergy Healthcare - Bradenton /ID# 284157
Bradenton, Florida, United States
Clinical Research of Osceola /ID# 280593
Kissimmee, Florida, United States
Florida Center For Gastroenterology - Largo /ID# 281059
Largo, Florida, United States
Research Associates of South Florida /ID# 280929
Miami, Florida, United States
Advanced Research Institute, Inc /ID# 281062
New Port Richey, Florida, United States
Digestive And Liver Center Of Florida - Orlando /ID# 280924
Orlando, Florida, United States
Gcp Clinical Research /ID# 280469
Tampa, Florida, United States
Gastroenterology Associates of Central Georgia /ID# 280464
Macon, Georgia, United States
Gastroenterology Consultants - Roswell /ID# 281235
Roswell, Georgia, United States
Treasure Valley Medical Research /ID# 281778
Boise, Idaho, United States
Midwest Digestive Health & Nutrition /ID# 285250
Des Plaines, Illinois, United States
Gi Alliance - Glenview /ID# 283932
Glenview, Illinois, United States
Illinois Gastroenterology Group /ID# 283933
Gurnee, Illinois, United States
Southwest Gastroenterology - Oak Lawn /ID# 280841
Oak Lawn, Illinois, United States
Gastroenterology Health Partners /ID# 284145
New Albany, Indiana, United States
Gastroenterology Health Partners /ID# 284144
Louisville, Kentucky, United States
Gastro Group and Endocenter: Mandeville, la /ID# 284186
Mandeville, Louisiana, United States
Metropolitan Gastroenterology Associates - Metairie /ID# 283922
Metairie, Louisiana, United States
Willis-Knighton Medical Center /ID# 280572
Shreveport, Louisiana, United States
Lucida Clinical Trials /ID# 282000
New Bedford, Massachusetts, United States
West Michigan Clinical Research Center /ID# 280480
Wyoming, Michigan, United States
Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
Flowood, Mississippi, United States
Gastroenterology Associates Of North Mississippi /ID# 285243
Oxford, Mississippi, United States
Specialists In Gastroenterology /ID# 283939
St Louis, Missouri, United States
Vector Clinical Trials /ID# 280843
Las Vegas, Nevada, United States
New York Gastroenterology Associates - Upper East Side /ID# 281767
New York, New York, United States
Digestive Health Partners /ID# 280490
Asheville, North Carolina, United States
Dayton Gastroenterology - Beavercreek /ID# 284065
Beavercreek, Ohio, United States
Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
Westlake, Ohio, United States
University Gastroenterology - Providence - Staniford Street /ID# 280919
Providence, Rhode Island, United States
Gastroenterology Associates - Patewood /ID# 283870
Greenville, South Carolina, United States
Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 283861
Knoxville, Tennessee, United States
Gastro One - Memphis /ID# 283948
Memphis, Tennessee, United States
Novel Research - Bellaire /ID# 280925
Bellaire, Texas, United States
Gi Alliance - Texas Digestive Disease Consultants - Fort Worth /ID# 283977
Fort Worth, Texas, United States
GI Alliance -Garland /ID# 284253
Garland, Texas, United States
Amel Med /ID# 283864
Georgetown, Texas, United States
Integrity Advanced Therapeutics /ID# 283871
Houston, Texas, United States
GI Alliance - Lubbock /ID# 283920
Lubbock, Texas, United States
Caprock Gastro Research - Lubbock /ID# 283921
Lubbock, Texas, United States
GI Alliance - Mansfield /ID# 283924
Mansfield, Texas, United States
Southern Star Research Institute /ID# 280822
San Antonio, Texas, United States
Center for Digestive Disease /ID# 280870
Shenandoah, Texas, United States
Texas Digestive Disease Consultants - Southlake /ID# 283931
Southlake, Texas, United States
Tyler Research Institute /ID# 284247
Tyler, Texas, United States
Emeritas Research Group /ID# 284388
Lansdowne Town Center, Virginia, United States
GI Alliance - Richmond /ID# 284244
Richmond, Virginia, United States
Washington Gastroenterology - Bellevue /ID# 283966
Bellevue, Washington, United States
Washington Gastroenterology - Tacoma /ID# 284143
Tacoma, Washington, United States
The Vancouver Clinic /ID# 280497
Vancouver, Washington, United States
Wisconsin Center for Advanced Research /ID# 284250
Milwaukee, Wisconsin, United States
Diex Recherche Quebec Inc. /ID# 282307
Québec, Canada
Assuta Ashdod Medical Center /ID# 280535
Ashdod, Southern District, Israel
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 280640
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 280630
Taichung, Taiwan