NCT07697456From ClinicalTrials.govRecruiting

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

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
Ulcerative Colitis

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: AbbVie
Enrolment target: 2,000
Started: 31 July 2026
Main results due: October 2031
Study sites: 51
Registry updated: 29 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(51)

Digestive Health Specialists /ID# 280827
Dothan, Alabama, United States
Recruiting
Elite Clinical Studies /ID# 280477
Phoenix, Arizona, United States
Recruiting
Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
Sun City, Arizona, United States
Recruiting
Clinnova Research /ID# 280509
Anaheim, California, United States
Recruiting
Southern California Res. Ctr /ID# 280476
Coronado, California, United States
Recruiting
Gastro Care Institute /ID# 281071
Lancaster, California, United States
Recruiting
United Medical Doctors - Los Alamitos /ID# 281125
Los Alamitos, California, United States
Recruiting
Inland Empire Liver Foundation - Rialto /ID# 280775
Rialto, California, United States
Recruiting
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
Colorado Springs, Colorado, United States
Recruiting
Synergy Healthcare - Bradenton - 17th Avenue West /ID# 284157
Bradenton, Florida, United States
Recruiting
Clinical Research of Osceola /ID# 280593
Kissimmee, Florida, United States
Recruiting
Florida Center For Gastroenterology - Largo /ID# 281059
Largo, Florida, United States
Recruiting
Research Associates of South Florida /ID# 280929
Miami, Florida, United States
Recruiting
Advanced Research Institute, Inc /ID# 281062
New Port Richey, Florida, United States
Recruiting
Digestive And Liver Center Of Florida - Orlando /ID# 280924
Orlando, Florida, United States
Recruiting
Gastroenterology Associates of Central Georgia /ID# 280464
Macon, Georgia, United States
Recruiting
Gastroenterology Consultants - Roswell /ID# 281235
Roswell, Georgia, United States
Recruiting
Treasure Valley Medical Research /ID# 281778
Boise, Idaho, United States
Recruiting
Gi Alliance - Glenview /ID# 283932
Glenview, Illinois, United States
Recruiting
Illinois Gastroenterology Group /ID# 283933
Gurnee, Illinois, United States
Recruiting
Southwest Gastroenterology - Oak Lawn /ID# 280841
Oak Lawn, Illinois, United States
Recruiting
Gastroenterology Health Partners /ID# 284144
Louisville, Kentucky, United States
Recruiting
Gastro Group and Endocenter: Mandeville, la /ID# 284186
Mandeville, Louisiana, United States
Recruiting
Metropolitan Gastroenterology Associates - Metairie /ID# 283922
Metairie, Louisiana, United States
Recruiting
Willis-Knighton Medical Center /ID# 280572
Shreveport, Louisiana, United States
Recruiting
Lucida Clinical Trials /ID# 282000
New Bedford, Massachusetts, United States
Recruiting
Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
Flowood, Mississippi, United States
Recruiting
Specialists In Gastroenterology /ID# 283939
St Louis, Missouri, United States
Recruiting
Vector Clinical Trials /ID# 280843
Las Vegas, Nevada, United States
Recruiting
New York Gastroenterology Associates - Upper East Side /ID# 281767
New York, New York, United States
Recruiting
Digestive Health Partners /ID# 280490
Asheville, North Carolina, United States
Recruiting
Dayton Gastroenterology - Englewood /ID# 284065
Englewood, Ohio, United States
Recruiting
Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
Westlake, Ohio, United States
Recruiting
University Gastroenterology - Providence - Staniford Street /ID# 280919
Providence, Rhode Island, United States
Recruiting
Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 283861
Knoxville, Tennessee, United States
Recruiting
Gastro One - Memphis /ID# 283948
Memphis, Tennessee, United States
Recruiting
Novel Research - Bellaire /ID# 280925
Bellaire, Texas, United States
Recruiting
GI Alliance -Garland /ID# 284253
Garland, Texas, United States
Recruiting
Amel Med /ID# 283864
Georgetown, Texas, United States
Recruiting
Integrity Advanced Therapeutics /ID# 283871
Houston, Texas, United States
Recruiting
GI Alliance - Lubbock /ID# 283920
Lubbock, Texas, United States
Recruiting
Caprock Gastro Research - Lubbock /ID# 283921
Lubbock, Texas, United States
Recruiting
GI Alliance - Mansfield /ID# 283924
Mansfield, Texas, United States
Recruiting
Southern Star Research Institute /ID# 280822
San Antonio, Texas, United States
Recruiting
Center for Digestive Disease /ID# 280870
Shenandoah, Texas, United States
Recruiting
Texas Digestive Disease Consultants - Southlake /ID# 283931
Southlake, Texas, United States
Recruiting
GI Alliance - Richmond /ID# 284244
Richmond, Virginia, United States
Recruiting
Washington Gastroenterology - Bellevue /ID# 283966
Bellevue, Washington, United States
Recruiting
Washington Gastroenterology - Tacoma /ID# 284143
Tacoma, Washington, United States
Recruiting
The Vancouver Clinic /ID# 280497
Vancouver, Washington, United States
Recruiting
China Medical University Hospital /ID# 280630
Taichung, Taiwan
Recruiting

Showing 51 of 51 sites. 51 of the 51 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07697456. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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