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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
NCT07697456 · AbbVie
In plain English
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Official title
A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
About this study
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.
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
Study design
Enrollment target: 2000 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-07-31
Estimated completion: 2031-10
Last updated: 2026-09-15
Interventions
Drug: RisankizumabDrug: TrosunilimabDrug: ABBV-701
Primary outcomes
- • Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission (At Week 28)
- • Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission (At Week 28)
- • Number of Participants with Adverse Events (AEs) (Up to 98 Weeks)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (32)
Digestive Health Specialists /ID# 280827Recruiting
Dothan, Alabama, United States
Elite Clinical Studies /ID# 280477Recruiting
Phoenix, Arizona, United States
Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084Recruiting
Sun City, Arizona, United States
Clinnova Research /ID# 280509Recruiting
Anaheim, California, United States
Gastro Care Institute /ID# 281071Recruiting
Lancaster, California, United States
United Medical Doctors - Los Alamitos /ID# 281125Recruiting
Los Alamitos, California, United States
Inland Empire Liver Foundation - Rialto /ID# 280775Recruiting
Rialto, California, United States
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507Recruiting
Colorado Springs, Colorado, United States
Clinical Research of Osceola /ID# 280593Recruiting
Kissimmee, Florida, United States
Research Associates of South Florida /ID# 280929Recruiting
Miami, Florida, United States
Advanced Research Institute, Inc /ID# 281062Recruiting
New Port Richey, Florida, United States
Digestive And Liver Center Of Florida - Orlando /ID# 280924Recruiting
Orlando, Florida, United States
Gastroenterology Associates of Central Georgia /ID# 280464Recruiting
Macon, Georgia, United States
Gastroenterology Consultants - Roswell /ID# 281235Recruiting
Roswell, Georgia, United States
Treasure Valley Medical Research /ID# 281778Recruiting
Boise, Idaho, United States
Southwest Gastroenterology - Oak Lawn /ID# 280841Recruiting
Oak Lawn, Illinois, United States
Gastroenterology Health Partners /ID# 284144Recruiting
Louisville, Kentucky, United States
Willis-Knighton Medical Center /ID# 280572Recruiting
Shreveport, Louisiana, United States
Vector Clinical Trials /ID# 280843Recruiting
Las Vegas, Nevada, United States
New York Gastroenterology Associates - Upper East Side /ID# 281767Recruiting
New York, New York, United States
Dayton Gastroenterology - Englewood /ID# 284065Recruiting
Englewood, Ohio, United States
Gastro Intestinal Research Institute of Northern Ohio /ID# 283860Recruiting
Westlake, Ohio, United States
University Gastroenterology - Providence - Staniford Street /ID# 280919Recruiting
Providence, Rhode Island, United States
Gastro One - Memphis /ID# 283948Recruiting
Memphis, Tennessee, United States
Novel Research - Bellaire /ID# 280925Recruiting
Bellaire, Texas, United States
Amel Med /ID# 283864Recruiting
Georgetown, Texas, United States
Integrity Advanced Therapeutics /ID# 283871Recruiting
Houston, Texas, United States
Southern Star Research Institute /ID# 280822Recruiting
San Antonio, Texas, United States
Washington Gastroenterology - Bellevue /ID# 283966Recruiting
Bellevue, Washington, United States
Washington Gastroenterology - Tacoma /ID# 284143Recruiting
Tacoma, Washington, United States
The Vancouver Clinic /ID# 280497Recruiting
Vancouver, Washington, United States
China Medical University Hospital /ID# 280630Recruiting
Taichung, Taiwan