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Could Two-Drug cocktails tame stubborn inflammatory bowel disease?

NCT ID NCT07697456

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Sep 04, 2026 · Updated 7 times

Summary

This study tests whether combining risankizumab with either trosunilimab or ABBV-701 can safely reduce inflammation and improve symptoms in adults with moderately to severely active Crohn's disease or ulcerative colitis. Participants are randomly assigned to one of the combination treatments or a placebo. The goal is to see if these advanced therapies can achieve endoscopic remission, meaning the gut lining heals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
risankizumab, trosunilimab, and ABBV-701
What this could lead to
If successful, these combination therapies could offer new treatment options for people with hard-to-control inflammatory bowel disease.
What could go wrong
This is an early-phase trial with a limited number of participants per arm, so results may not apply to everyone. Side effects are possible, and the combinations may not prove more effective than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Research Institute, Inc /ID# 281062

    RECRUITING

    New Port Richey, Florida, 34653, United States

  • Amel Med /ID# 283864

    RECRUITING

    Georgetown, Texas, 78628, United States

  • China Medical University Hospital /ID# 280630

    RECRUITING

    Taichung, 40447, Taiwan

  • Clinical Research of Osceola /ID# 280593

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Clinnova Research /ID# 280509

    RECRUITING

    Anaheim, California, 92805, United States

  • Digestive Health Specialists /ID# 280827

    RECRUITING

    Dothan, Alabama, 36301, United States

  • Elite Clinical Studies /ID# 280477

    RECRUITING

    Phoenix, Arizona, 85018, United States

  • Gastro Care Institute /ID# 281071

    RECRUITING

    Lancaster, California, 93534, United States

  • Gastro One - Memphis /ID# 283948

    RECRUITING

    Memphis, Tennessee, 38104, United States

  • Gastroenterology Associates of Central Georgia /ID# 280464

    RECRUITING

    Macon, Georgia, 31201, United States

  • Gastroenterology Consultants - Roswell /ID# 281235

    RECRUITING

    Roswell, Georgia, 30076, United States

  • Gastroenterology Health Partners /ID# 284144

    RECRUITING

    Louisville, Kentucky, 40218, United States

  • Inland Empire Liver Foundation - Rialto /ID# 280775

    RECRUITING

    Rialto, California, 92377, United States

  • Integrity Advanced Therapeutics /ID# 283871

    RECRUITING

    Houston, Texas, 77090, United States

  • New York Gastroenterology Associates - Upper East Side /ID# 281767

    RECRUITING

    New York, New York, 10075, United States

  • Novel Research - Bellaire /ID# 280925

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Research Associates of South Florida /ID# 280929

    RECRUITING

    Miami, Florida, 33134, United States

  • Southern Star Research Institute /ID# 280822

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Southwest Gastroenterology - Oak Lawn /ID# 280841

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • The Vancouver Clinic /ID# 280497

    RECRUITING

    Vancouver, Washington, 98664, United States

  • Treasure Valley Medical Research /ID# 281778

    RECRUITING

    Boise, Idaho, 83706, United States

  • United Medical Doctors - Los Alamitos /ID# 281125

    RECRUITING

    Los Alamitos, California, 90720, United States

  • University Gastroenterology - Providence - Staniford Street /ID# 280919

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • Vector Clinical Trials /ID# 280843

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Washington Gastroenterology - Tacoma /ID# 284143

    RECRUITING

    Tacoma, Washington, 98405, United States

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