Clinical trial Recruiting at 14 sites Phase 3 Interventional Ages 6 to 17

Upadacitinib for Severe Alopecia Areata in Children

Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of Upadacitinib in Pediatric Subjects With Severe Alopecia Areata

Run by AbbVie · NCT07772492 · Data updated 2026-11-12

This study tests whether upadacitinib can safely help children with severe alopecia areata grow back hair, compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Ages6 Years to 17 Years
SexAll
Enrollment300 (estimated)
SponsorAbbVie
Industry-sponsored
Drugs / interventionsupadacitinib
Locations14 sites (Los Angeles, California and 13 other locations)
StatusRecruiting
StartedAugust 24, 2026
Main results expectedMarch 2032
Study endsMarch 2032
Registry record updatedOctober 27, 2026
Trial IDNCT07772492 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children with severe alopecia areata (SALT ≥ 50%), no significant scalp hair regrowth in the past 6 months, and an active AA episode lasting less than 8 years.

Probably not a fit

Patients with diffuse hair loss types unrelated to AA or those outside the eligible disease duration may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 3 trial compares different doses of upadacitinib to placebo in pediatric participants with severe alopecia areata. Eligible participants have SALT hair loss of 50% or more on the scalp and no regrowth in 6 months. The study aims to determine safety and the best dose to improve hair restoration over time. Enrolled participants will receive either upadacitinib or a placebo and will be monitored for responses and adverse events. The trial is sponsored by AbbVie and conducted at multiple dermatology centers in the United States.

Why it matters

Potential benefit: If successful, participants could experience improved hair regrowth and a potential new systemic treatment option for pediatric severe alopecia areata.

How similar studies have gone: Previous studies in adults and some pediatric research suggest JAK inhibitors can improve AA symptoms, but results in children require confirmation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Participants must have a diagnosis of severe alopecia areata with SALT score \>= 50 scalp hair loss at Screening and Baseline
* No spontaneous scalp hair regrowth over the past 6 months
* Participants will have current episode of alopecia areata of less than 8 years

Exclusion Criteria:

* Participants must not have a current diagnosis of primarily diffuse type of alopecia areata
* Participants must not have a diagnosis of other types of alopecia that would interfere with evaluation of alopecia areata, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium
* Participants must not have a diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of alopecia areata, including but not limited to seborrheic dermatitis, scalp psoriasis, AD, and tinea capitis

Where it's running

  • Dermatology Research Associates - Los Angeles /ID# 282821
    Los Angeles, California, United States
    Recruiting
  • Pediatric Skin Research - Miami /ID# 283281
    Miami, Florida, United States
    Recruiting
  • Ada West Research /ID# 283063
    Meridian, Idaho, United States
    Recruiting
  • Dawes Fretzin- Indianapolis /ID# 283498
    Indianapolis, Indiana, United States
    Recruiting
  • Skin Specialists /ID# 283358
    Omaha, Nebraska, United States
    Recruiting
  • Dermatologists of Southwestern Ohio (DSWO) /ID# 282818
    Fairborn, Ohio, United States
    Recruiting
Show 8 more locations
  • 3A Research - East location /ID# 283404
    El Paso, Texas, United States
    Recruiting
  • Texas Dermatology and Laser Specialists /ID# 282813
    San Antonio, Texas, United States
    Recruiting
  • Virginia Clinical Research /ID# 283797
    Norfolk, Virginia, United States
    Recruiting
  • Premier Dermatology - Kogarah /ID# 283484
    Kogarah, New South Wales, Australia
    Recruiting
  • Cornerstone Dermatology - Coorparoo /ID# 284160
    Coorparoo, Queensland, Australia
    Recruiting
  • Sinclair Dermatology - Melbourne /ID# 283854
    East Melbourne, Victoria, Australia
    Recruiting
  • Shinsaibashi Inui Dermatology Clinic. /ID# 282706
    Osaka, Osaka, Japan
    Recruiting
  • Taipei Veterans General Hospital /ID# 282900
    Taipei, Taiwan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.