Status:
RECRUITING
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
Lead Sponsor:
AbbVie
Conditions:
Alopecia Areata
Eligibility:
All Genders
12-63 years
Phase:
PHASE3
Brief 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 bod...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06012240
Start Date
October 11 2023
End Date
January 1 2028
Last Update
December 30 2025
Active Locations (267)
Enter a location and click search to find clinical trials sorted by distance.
1
Total Skin and Beauty Dermatology Center /ID# 259539
Birmingham, Alabama, United States, 35205
2
Duplicate_Advanced Research Associates - Glendale /ID# 259108
Glendale, Arizona, United States, 85308
3
Southwest Skin Specialists /ID# 258234
Phoenix, Arizona, United States, 85018-3953
4
Alliance Dermatology and Mohs Center /ID# 258111
Phoenix, Arizona, United States, 85032