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

RecruitingPhase 3Ages 12 Years - 63 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 plac

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Upadacitinib
  • Placebo
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Where

272 sites
Total Skin and Beauty Dermatology Center /ID# 259539
Birmingham, United States
Duplicate_Advanced Research Associates - Glendale /ID# 259108
Glendale, United States
Southwest Skin Specialists /ID# 258234
Phoenix, United States
Alliance Dermatology and Mohs Center /ID# 258111
Phoenix, United States
Johnson Dermatology Clinic /ID# 259103
Fort Smith, United States
Duplicate_JOSEPH RAOOF MD,INC /ID# 258031
Encino, United States
First Oc Dermatology /ID# 259220
Fountain Valley, United States
University of California Irvine /ID# 259096
Irvine, United States

โ€ฆand 264 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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