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Study of Upadacitinib for Severe Alopecia Areata

This study is testing a medication called upadacitinib in adults and adolescents (ages 12-63) with severe alopecia areata (AA). AA is a condition where your immune system attacks hair follicles, causing hair loss. The study aims to find out how safe and effective upadacitinib is, and how well people tolerate it. Upadacitinib is an approved drug that is now being studied for AA. Participants will receive either upadacitinib or a placebo (an inactive substance) in tablet form. The main goal is to see how many participants achieve significant hair regrowth (SALT score ≤ 20) by 24 weeks. The study plans to enroll about 1500 people, but its current status is unclear.

Study design
This is an interventional study where participants are randomly assigned to one of three treatment groups: upadacitinib, a different upadacitinib dose, or a placebo. There is a 1 in 5 chance of receiving the placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to approximately 164 weeks.

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NCT06012240

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

Recruiting
PHASE3Ages 12–63InterventionalTreatment
AbbVie
~1,500 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:UpadacitinibPlacebo

At a glance

Recruiting sites
46 of 283 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
Measured over Week 24
+1 more outcome measured

Conditions

Alopecia Areata

Explore related trials

Alopecia

Where it's being run

283 sites across 143 states
Florida13
Texas13
California9
Ontario8
Michigan7
New York6
Guangdong6
Puerto Rico5

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20Week 24

    The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.

  • Number of Participants with Adverse Events (AEs)Up to approximately 164 weeks

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.