A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis

Study Identifier
M18-816
CT.gov Identifier
NCT05044234
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, Japanese
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
  • Cedirogant
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
    Exclusion Criteria:
    * Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis. * Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.

    Protocol Summary

    Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis.

    Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo.

    Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks.

    There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.

    Study Locations

    Location
    Status
    Location
    UAB Department of Dermatology /ID# 238563
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Medical Dermatology Specialist /ID# 238518
    Phoenix, Arizona, United States, 85006-2722
    Status
    Not applicable
    Location
    Arkansas Research Trials, LLC /ID# 238687
    North Little Rock, Arkansas, United States, 72117
    Status
    Not applicable
    Location
    Encino Research Center /ID# 245950
    Encino, California, United States, 91436
    Status
    Not applicable
    Location
    Velocity Clinical Research, Inc. /ID# 239536
    North Hollywood, California, United States, 91606
    Status
    Not applicable
    Location
    Medderm Associates /ID# 238834
    San Diego, California, United States, 92103
    Status
    Not applicable
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