A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis

Study Identifier
M24-727
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
  • Study Drug
  • Lutikizumab
  • Placebo
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to evaluate the clinical efficacy and safety of single therapies and/or combination therapies for moderate to severe AD through multiple substudies.

    This study will consist of multiple sub-studies, Sub-Study 1 will have a randomized, placebo controlled period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio.

    In Sub-Study 1, participants will receive subcutaneous (SC) injections of lutikizumab or matching placebo every other week for 16 weeks followed by an additional 32 weeks of subcutaneous (SC) injections of lutikizumab every other week for a total of 52 weeks.

    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 and may require frequent medical assessments, blood tests, and biomarker collections.

    Study Locations

    Location
    Status
    Location
    Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550
    Fountain Hills, Arizona, United States, 85268
    Status
    Not applicable
    Location
    Dermatology Research Associates - Los Angeles /ID# 272945
    Los Angeles, California, United States, 90045
    Status
    Not applicable
    Location
    Integrative Skin Science and Research /ID# 274243
    Sacramento, California, United States, 95815
    Status
    Not applicable
    Location
    Clinical Trials Research Institute /ID# 274234
    Thousand Oaks, California, United States, 91320
    Status
    Not applicable
    Location
    Western States Clinical Res /ID# 271748
    Wheat Ridge, Colorado, United States, 80033-2896
    Status
    Not applicable
    Location
    Skin Care Research Boca Raton /ID# 272544
    Boca Raton, Florida, United States, 33486-2269
    Status
    Not applicable
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