Alopecia Areata Clinical Study (16-64 yrs)| Cedar Park, TX

A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata

Study Description

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.

Brief Summary

The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.

Condition or Disease

Areata Alopecia

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	1,500
Primary Outcome Measures	Percentage of Participants with the Achievement of Severity of Alopecia
Actual Study Start Date:	October 2023
Estimated Primary Completion Date:	January 2028

Eligibility Criteria

Ages Eligible for Study:	16 to 64 Years Old
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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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Severe Alopecia Areata Study (16-64 Years)