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Completed

NCT Number: NCT05570006

Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants 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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Gent /ID# 248605, Ghent, Oost-Vlaanderen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-668

Drug

Oral Capsule

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2022
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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