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Taking people in United StatesPhase 2

Testing risankizumab combined with other drugs in Crohn's disease and ulcerative colitis

Tests risankizumab with trosunilimab or ABBV-701 in adults with active Crohn's disease or ulcerative colitis.

Plain-language title generated from the registry record
Registry title: Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Key facts

Where
Anaheim, Asheville, Beavercreek, Bellaire, Bellevue, Boise, Bradenton, Colorado Springs, Coronado, Des Plaines, Dothan, Flowood, Fort Worth, Garland, Georgetown, Glenview, Greenville, Gurnee, Houston, Kissimmee, Knoxville, Lancaster, Lansdowne Town Center, Largo, Las Vegas, Los Alamitos, Louisville, Lubbock, Macon, Mandeville, Mansfield, Memphis, Metairie, Miami, Milwaukee, New Albany, New Bedford, New Port Richey, New York, Oak Lawn, Orlando, Oxford, Phoenix, Providence, Rialto, Richmond, Roswell, San Antonio, Shenandoah, Shreveport, Southlake, St Louis, Sun City, Tacoma, Tampa, Tyler, Vancouver, Webster, Westlake, and Wyoming, United StatesSee the 61 sites
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT07697456, who can take part

Where in United States

  • Clinnova Research /ID# 280509Anaheim, United StatesTaking people
  • Digestive Health Partners /ID# 280490Asheville, United StatesTaking people
  • Dayton Gastroenterology - Beavercreek /ID# 284065Beavercreek, United StatesTaking people
  • Novel Research - Bellaire /ID# 280925Bellaire, United StatesTaking people
  • Washington Gastroenterology - Bellevue /ID# 283966Bellevue, United StatesTaking people
  • Treasure Valley Medical Research /ID# 281778Boise, United StatesTaking people
  • Synergy Healthcare - Bradenton /ID# 284157Bradenton, United StatesTaking people
  • Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507Colorado Springs, United StatesTaking people
  • Southern California Res. Ctr /ID# 280476Coronado, United StatesTaking people
  • Midwest Digestive Health & Nutrition /ID# 285250Des Plaines, United StatesTaking people
  • Digestive Health Specialists /ID# 280827Dothan, United StatesTaking people
  • Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967Flowood, United StatesTaking people
  • Gi Alliance - Texas Digestive Disease Consultants - Fort Worth /ID# 283977Fort Worth, United StatesTaking people
  • GI Alliance -Garland /ID# 284253Garland, United StatesTaking people
  • Amel Med /ID# 283864Georgetown, United StatesTaking people
  • Gi Alliance - Glenview /ID# 283932Glenview, United StatesTaking people
  • Gastroenterology Associates - Patewood /ID# 283870Greenville, United StatesTaking people
  • Illinois Gastroenterology Group /ID# 283933Gurnee, United StatesTaking people
  • Integrity Advanced Therapeutics /ID# 283871Houston, United StatesTaking people
  • Clinical Research of Osceola /ID# 280593Kissimmee, United StatesTaking people
  • Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 283861Knoxville, United StatesTaking people
  • Gastro Care Institute /ID# 281071Lancaster, United StatesTaking people
  • Emeritas Research Group /ID# 284388Lansdowne Town Center, United StatesTaking people
  • Florida Center For Gastroenterology - Largo /ID# 281059Largo, United StatesTaking people
  • Vector Clinical Trials /ID# 280843Las Vegas, United StatesTaking people
  • United Medical Doctors - Los Alamitos /ID# 281125Los Alamitos, United StatesTaking people
  • Gastroenterology Health Partners /ID# 284144Louisville, United StatesTaking people
  • Caprock Gastro Research - Lubbock /ID# 283921Lubbock, United StatesTaking people
  • GI Alliance - Lubbock /ID# 283920Lubbock, United StatesTaking people
  • Gastroenterology Associates of Central Georgia /ID# 280464Macon, United StatesTaking people
  • Gastro Group and Endocenter: Mandeville, la /ID# 284186Mandeville, United StatesTaking people
  • GI Alliance - Mansfield /ID# 283924Mansfield, United StatesTaking people
  • Gastro One - Memphis /ID# 283948Memphis, United StatesTaking people
  • Metropolitan Gastroenterology Associates - Metairie /ID# 283922Metairie, United StatesTaking people
  • Research Associates of South Florida /ID# 280929Miami, United StatesTaking people
  • Wisconsin Center for Advanced Research /ID# 284250Milwaukee, United StatesTaking people
  • Gastroenterology Health Partners /ID# 284145New Albany, United StatesTaking people
  • Lucida Clinical Trials /ID# 282000New Bedford, United StatesTaking people
  • Advanced Research Institute, Inc /ID# 281062New Port Richey, United StatesTaking people
  • New York Gastroenterology Associates - Upper East Side /ID# 281767New York, United StatesTaking people
  • Southwest Gastroenterology - Oak Lawn /ID# 280841Oak Lawn, United StatesTaking people
  • Digestive And Liver Center Of Florida - Orlando /ID# 280924Orlando, United StatesTaking people
  • Gastroenterology Associates Of North Mississippi /ID# 285243Oxford, United StatesTaking people
  • Elite Clinical Studies /ID# 280477Phoenix, United StatesTaking people
  • University Gastroenterology - Providence - Staniford Street /ID# 280919Providence, United StatesTaking people
  • Inland Empire Liver Foundation - Rialto /ID# 280775Rialto, United StatesTaking people
  • GI Alliance - Richmond /ID# 284244Richmond, United StatesTaking people
  • Gastroenterology Consultants - Roswell /ID# 281235Roswell, United StatesTaking people
  • Southern Star Research Institute /ID# 280822San Antonio, United StatesTaking people
  • Center for Digestive Disease /ID# 280870Shenandoah, United StatesTaking people
  • Willis-Knighton Medical Center /ID# 280572Shreveport, United StatesTaking people
  • Texas Digestive Disease Consultants - Southlake /ID# 283931Southlake, United StatesTaking people
  • Specialists In Gastroenterology /ID# 283939St Louis, United StatesTaking people
  • Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084Sun City, United StatesTaking people
  • Washington Gastroenterology - Tacoma /ID# 284143Tacoma, United StatesTaking people
  • Gcp Clinical Research /ID# 280469Tampa, United StatesTaking people
  • Tyler Research Institute /ID# 284247Tyler, United StatesTaking people
  • The Vancouver Clinic /ID# 280497Vancouver, United StatesTaking people
  • Texas Digestive Disease Consultants /ID# 284245Webster, United StatesTaking people
  • Gastro Intestinal Research Institute of Northern Ohio /ID# 283860Westlake, United StatesTaking people
  • West Michigan Clinical Research Center /ID# 280480Wyoming, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
AbbVie
Trial code
NCT07697456EU 2026-525959-86-00
Record updated
27 October 2026
Original 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).Read full original descriptionShow less

A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT07697456 · EU CTIS 2026-525959-86-00