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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | upadacitinib |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Status | Recruiting |
| Started | August 24, 2026 |
| Main results expected | March 2032 |
| Study ends | March 2032 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07772492 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
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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
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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
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.