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New pill shows promise for ulcerative colitis in early trial

NCT ID NCT05570006

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called ABBV-668 in 30 adults with moderate to severe ulcerative colitis, a condition that causes inflammation and bleeding in the colon. Participants took the drug twice daily for 16 weeks, and researchers checked for side effects and signs of improvement using a scope. The goal was to see if the drug is safe and can reduce bowel inflammation.

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

30 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2024

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 years and older

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: * Diagnosis of ulcerative colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available. * Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review). * Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or targeted immunomodulators (including biologics and non-biologics) Exclusion Criteria: * Current diagnosis of crohn's disease (CD) or inflammatory bowel disease-unclassified (IBD-U). * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

Contacts and locations

Locations

  • Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079

    Pittsburgh, Pennsylvania, 15212, United States

  • Atlantic Medical Research /ID# 249213

    Margate, Florida, 33063-5737, United States

  • Atrium Health /ID# 249273

    Charlotte, North Carolina, 28204-2963, United States

  • Baylor College of Medicine /ID# 249203

    Houston, Texas, 77030, United States

  • CHU Grenoble - Hopital Michallon /ID# 252108

    La Tronche, Isere, 38700, France

  • CHU Montpellier - Hopital Saint Eloi /ID# 251876

    Montpellier, Herault, 34295, France

  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875

    St-Priest-en-Jarez, Pays de la Loire Region, 42270, France

  • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357

    Neuilly-sur-Seine, Île-de-France Region, 92200, France

  • Columbia University Medical Center /ID# 250189

    New York, New York, 10032-3729, United States

  • Ctr for Advanced Gastroenterol /ID# 249226

    Maitland, Florida, 32751-6108, United States

  • Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208

    Garland, Texas, 75044, United States

  • Endoscopic Research, Inc. /ID# 249202

    Orlando, Florida, 32803, United States

  • Endoskopia Sp. z o.o. /ID# 255667

    Sopot, Pomeranian Voivodeship, 81-756, Poland

  • Gastro SB /ID# 249271

    Chula Vista, California, 91910-5619, United States

  • Gastroenterology Associates of Central Georgia, LLC /ID# 249278

    Macon, Georgia, 31201, United States

  • Gastroenterology Associates, P.A. of Greenville /ID# 249217

    Greenville, South Carolina, 29607, United States

  • Gastromed Sp. z o.o /ID# 255664

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Groupe Sante CHC - Clinique du MontLegia /ID# 248928

    Liège, 4000, Belgium

  • H-T Centrum Medyczne Endoterapia /ID# 255666

    Tychy, Silesian Voivodeship, 43-100, Poland

  • Lenox Hill Hospital /ID# 250008

    New York, New York, 10075, United States

  • Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663

    Warsaw, Masovian Voivodeship, 00-728, Poland

  • NYU Langone Long Island Clinical Research Associates /ID# 250075

    Lake Success, New York, 11042, United States

  • Options Health Research, LLC /ID# 249216

    Tulsa, Oklahoma, 74104, United States

  • Quality Medical Research /ID# 251125

    Nashville, Tennessee, 37211, United States

  • Southern Star Research Institute, LLC /ID# 249212

    San Antonio, Texas, 78229-5390, United States

  • UZ Gent /ID# 248605

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitair Ziekenhuis Leuven /ID# 248598

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University of Pennsylvania /ID# 250012

    Philadelphia, Pennsylvania, 19104-5502, United States

  • University of Pittsburgh MC /ID# 250071

    Pittsburgh, Pennsylvania, 15260, United States

  • Vitaz /Id# 248607

    Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

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