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RECRUITING Phase 2 ClinicalTrials.gov

Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07697456

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Risankizumab (Drug)
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
  • Trosunilimab (Drug)
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
  • ABBV-701 (Drug)
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Eligibility criteria

Inclusion Criteria: CD specific: * Crohn's Disease Activity Index (CDAI) score of ≥ 220 * Confirmed diagnosis of CD at least 90 days prior to Baseline * Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. * Demonstrated failure of 1 or more therapy for CD UC specific: * Confirmed diagnosis of UC at least 90 days prior to Baseline * Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3 * Demonstrated failure of 1 or more therapy for UC Exclusion Criteria: * Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab) * Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment * Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame * Participants with surgical bowel resection within the past 3 months prior to Baseline CD specific: * Participants with \>3 prior bowel resections * Participants with previous small bowel resection(s) of combined length \>100 cm UC specific: * Participants with prior colectomy (total or subtotal) * Participants with extent of disease limited to \< 10 cm of rectum

Conditions

Crohn's Disease Ulcerative Colitis

Locations

  • 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
  • Texas Digestive Disease Consultants /ID# 284245 — Webster, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record