[M23-716] A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants with Severe Alopecia Areata
- Conditions
- Alopecia Areata
- Registration Number
- JPRN-jRCT2041230114
- Lead Sponsor
- Tetsuya Otani
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1400
Adult individuals < 64 years old at Baseline Visit. Where permitted outside United States (OUS), adolescent individuals who are at least 12 years old at Screening may participate.
-Diagnosis of severe AA with SALT score 50 scalp hair loss at Screening and Baseline.
-Severe AA with no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months.
-Current episode of AA of less than 8 years.
-Diagnosis of primarily diffuse type of AA.
-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, includin g but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20 (Time frame: Week 24)
- Secondary Outcome Measures
Name Time Method