Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis

December 8, 2025 updated by: AbbVie

A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed.

ABBV-668 is an investigational drug being developed for the treatment of moderate to severe UC. Approximately 40 adult participants diagnosed with UC will be enrolled in approximately 30 sites globally.

Participants will receive oral capsules of ABBV-668 twice daily for 16 weeks and will undergo a 30 day follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Groupe Sante CHC - Clinique du MontLegia /ID# 248928
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 248605
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • Vitaz /Id# 248607
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 248598
  • France
    • Herault
      • Montpellier, Herault, France, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 251876
    • Isere
      • La Tronche, Isere, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 252108
    • Pays de la Loire Region
      • St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
        • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875
    • Île-de-France Region
      • Neuilly-sur-Seine, Île-de-France Region, France, 92200
        • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Gastromed Sp. z o.o /ID# 255664
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-728
        • Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663
    • Pomeranian Voivodeship
      • Sopot, Pomeranian Voivodeship, Poland, 81-756
        • Endoskopia Sp. z o.o. /ID# 255667
    • Silesian Voivodeship
      • Tychy, Silesian Voivodeship, Poland, 43-100
        • H-T Centrum Medyczne Endoterapia /ID# 255666
  • United States
    • California
      • Chula Vista, California, United States, 91910-5619
        • Gastro SB /ID# 249271
    • Florida
      • Maitland, Florida, United States, 32751-6108
        • Ctr for Advanced Gastroenterol /ID# 249226
      • Margate, Florida, United States, 33063-5737
        • Atlantic Medical Research /ID# 249213
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc. /ID# 249202
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 249278
    • New York
      • Lake Success, New York, United States, 11042
        • NYU Langone Long Island Clinical Research Associates /ID# 250075
      • New York, New York, United States, 10075
        • Lenox Hill Hospital /ID# 250008
      • New York, New York, United States, 10032-3729
        • Columbia University Medical Center /ID# 250189
    • North Carolina
      • Charlotte, North Carolina, United States, 28204-2963
        • Atrium Health /ID# 249273
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC /ID# 249216
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-5502
        • University of Pennsylvania /ID# 250012
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh MC /ID# 250071
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Gastroenterology Associates, P.A. of Greenville /ID# 249217
    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research /ID# 251125
    • Texas
      • Garland, Texas, United States, 75044
        • Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine /ID# 249203
      • San Antonio, Texas, United States, 78229-5390
        • Southern Star Research Institute, LLC /ID# 249212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-668
Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks.
Drug: ABBV-668
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Endoscopic Improvement
Time Frame: Week 8
Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes.
Week 8
Number of Participants With Adverse Events (AEs)
Time Frame: From the time of first study drug administration until 30 days after the last dose of study drug (Up to approximately 20 weeks)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
From the time of first study drug administration until 30 days after the last dose of study drug (Up to approximately 20 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
Time Frame: Baseline, Week 8

The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

  • Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
  • Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
  • Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.

Clinical remission per Adapted Mayo Score was defined as SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1. Data are reported for the percentage of participants achieving clinical remission per adapted Mayo score.
Baseline, Week 8
Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
Time Frame: Baseline, Week 8

The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).

Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).

Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.

Clinical response per Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per adapted Mayo score.
Baseline, Week 8
Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score
Time Frame: Baseline, Week 8

The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores:

Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).

Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).

The overall Partial Adapted Mayo score ranges from 0 to 6 where higher scores represent more severe disease.

Clinical response per Partial Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 1 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per partial adapted Mayo score.
Baseline, Week 8
Percentage of Participants Achieving Endoscopic Remission
Time Frame: Week 8
Endoscopic remission was defined as Mayo endoscopic subscore of 0. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Actual)

December 23, 2024

Study Completion (Actual)

December 23, 2024

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M21-446
  • 2022-501263-41-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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