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

ClinicalTrials.gov ID: NCT07697456

Public ClinicalTrials.gov record NCT07697456. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 8:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT07697456
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: AbbVie; Industry
Enrollment: 2,000 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 30, 2026
Primary completion: Sep 30, 2031
Completion: Sep 30, 2031
Last update posted: Sep 2, 2026

2026 – 2031

United States locations

U.S. sites: 25
U.S. states: 15
U.S. cities: 25

Facility	City	State	ZIP	Site status
Digestive Health Specialists /ID# 280827	Dothan	Alabama	36301	Recruiting
Elite Clinical Studies /ID# 280477	Phoenix	Arizona	85018	Recruiting
Clinnova Research /ID# 280509	Anaheim	California	92805	Recruiting
Gastro Care Institute /ID# 281071	Lancaster	California	93534	Recruiting
United Medical Doctors - Los Alamitos /ID# 281125	Los Alamitos	California	90720	Recruiting
Inland Empire Liver Foundation - Rialto /ID# 280775	Rialto	California	92377	Recruiting
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507	Colorado Springs	Colorado	80907	Recruiting
Clinical Research of Osceola /ID# 280593	Kissimmee	Florida	34741	Recruiting
Research Associates of South Florida /ID# 280929	Miami	Florida	33134	Recruiting
Advanced Research Institute, Inc /ID# 281062	New Port Richey	Florida	34653	Recruiting
Gastroenterology Associates of Central Georgia /ID# 280464	Macon	Georgia	31201	Recruiting
Gastroenterology Consultants - Roswell /ID# 281235	Roswell	Georgia	30076	Recruiting
Treasure Valley Medical Research /ID# 281778	Boise	Idaho	83706	Recruiting
Southwest Gastroenterology - Oak Lawn /ID# 280841	Oak Lawn	Illinois	60453	Recruiting
Gastroenterology Health Partners /ID# 284144	Louisville	Kentucky	40218	Recruiting
Vector Clinical Trials /ID# 280843	Las Vegas	Nevada	89128	Recruiting
New York Gastroenterology Associates - Upper East Side /ID# 281767	New York	New York	10075	Recruiting
University Gastroenterology - Providence - Staniford Street /ID# 280919	Providence	Rhode Island	02905	Recruiting
Gastro One - Memphis /ID# 283948	Memphis	Tennessee	38104	Recruiting
Novel Research - Bellaire /ID# 280925	Bellaire	Texas	77401	Recruiting
Amel Med /ID# 283864	Georgetown	Texas	78628	Recruiting
Integrity Advanced Therapeutics /ID# 283871	Houston	Texas	77090	Recruiting
Southern Star Research Institute /ID# 280822	San Antonio	Texas	78229	Recruiting
Washington Gastroenterology - Tacoma /ID# 284143	Tacoma	Washington	98405	Recruiting
The Vancouver Clinic /ID# 280497	Vancouver	Washington	98664	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07697456, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 2, 2026 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07697456 live on ClinicalTrials.gov.

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