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

Study Identifier
M21-446
CT.gov Identifier
NCT05570006
EudraCT Identifier
Not available
EUCTIS ID
2022-501263-41-00
For general inquiries, please contact

844-663-3742 or [email protected]

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Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Plain Language Summary
Available Language(s): English, German (Belgium), French (Belgium), Dutch (Belgium), French
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • ABBV-668
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Gastro SB /ID# 249271
    Chula Vista, California, United States, 91910-5619
    Status
    Not applicable
    Location
    Ctr for Advanced Gastroenterol /ID# 249226
    Maitland, Florida, United States, 32751-6108
    Status
    Not applicable
    Location
    Atlantic Medical Research /ID# 249213
    Margate, Florida, United States, 33063-5737
    Status
    Not applicable
    Location
    Endoscopic Research, Inc. /ID# 249202
    Orlando, Florida, United States, 32803
    Status
    Not applicable
    Location
    Gastroenterology Associates of Central Georgia, LLC /ID# 249278
    Macon, Georgia, United States, 31201
    Status
    Not applicable
    Location
    NYU Langone Long Island Clinical Research Associates /ID# 250075
    Lake Success, New York, United States, 11042
    Status
    Not applicable
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