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Upadacitinib tablets for severe alopecia areata in adolescents and adults

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

Phase 3 Interventional AbbVie · NCT06012240

This trial will try upadacitinib tablets to see if they are safe and help regrow hair in adolescents and adults with severe alopecia areata.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1500 (estimated)
Ages12 Years to 63 Years
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsupadacitinib
Locations269 sites (Birmingham, Alabama and 268 other locations)
Trial IDNCT06012240 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, placebo-controlled trial tests oral upadacitinib tablets in adolescents and adults with severe alopecia areata. Eligible participants have a SALT score ≥ 50, a current episode under 8 years, and no spontaneous regrowth in the past 6 months. Participants are randomized into one of three treatment arms with a 1-in-5 chance of receiving placebo in the initial period; active-dose participants generally continue the same treatment into the second period while some placebo recipients may remain on placebo or be re-randomized to an active dose based on severity. The trial is sponsored by AbbVie and is enrolling at several US dermatology centers.

Who should consider this trial

Good fit: Adolescents (≥12 where permitted) and adults under 64 with severe alopecia areata (SALT ≥ 50), a current episode under 8 years, and no spontaneous regrowth in the prior 6 months are the intended participants.

Not a fit: Patients with primarily diffuse alopecia or other non-alopecia areata hair disorders (for example advanced androgenetic alopecia or lichen planopilaris) or those aged ≥64 are unlikely to meet eligibility or benefit from this protocol.

Why it matters

Potential benefit: If successful, upadacitinib could restore significant scalp hair and improve quality of life for people with severe alopecia areata.

How similar studies have performed: Other studies of JAK inhibitors, including prior upadacitinib and related agents, have shown promising hair regrowth in alopecia areata, so this approach builds on existing positive signals.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 268 other locations

+219 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alopecia AreataUpadacitinibRinvoqABT-494
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.