A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Study Identifier
M23-716
CT.gov Identifier
NCT06012240
EudraCT Identifier
Not available
EUCTIS ID
2023-505061-82-01
For general inquiries, please contact

844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Alopecia Areata
    • Study Drug
  • Upadacitinib
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12 - 63 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Adult individuals must be \< 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4. * Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \>= 50 scalp hair loss at Screening and Baseline. * Severe AA with no spontaneous scalp hair regrowth over the past 6 months. * Current episode of AA of less than 8 years.
    Exclusion Criteria:
    * Current diagnosis of primarily diffuse type of AA. * Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium. * Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

    Protocol Summary

    Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.

    Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.

    Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.

    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, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Dermatology Center /ID# 259539
    Birmingham, Alabama, United States, 35205
    Status
    Active, Not Recruiting
    Location
    Duplicate_Advanced Research Associates - Glendale /ID# 259108
    Glendale, Arizona, United States, 85308
    Status
    Completed
    Location
    Southwest Skin Specialists /ID# 258234
    Phoenix, Arizona, United States, 85018-3953
    Status
    Completed
    Location
    Alliance Dermatology and Mohs Center /ID# 258111
    Phoenix, Arizona, United States, 85032
    Status
    Active, Not Recruiting
    Location
    Johnson Dermatology Clinic /ID# 259103
    Fort Smith, Arkansas, United States, 72916-6103
    Status
    Active, Not Recruiting
    Location
    Duplicate_JOSEPH RAOOF MD,INC /ID# 258031
    Encino, California, United States, 91436
    Status
    Completed
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