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Taking people in United StatesPhase 3

A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata

Key facts

Who runs it
AbbVie
Where
El Paso, Fairborn, Indianapolis, Los Angeles, Meridian, Miami, Norfolk, Omaha, and San Antonio, United StatesSee the 9 sitesAlso in 3 other countries, 5 sites
Status
Recruiting
Phase
Phase 3
People taking part
300 people, planned
Started
24 Aug 2026
Expected to end
Mar 2032
Type of study
Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Upadacitinib
  • Placebo
Record updated
27 October 2026

Who can take part

Age
6 years to 17 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

Where in United States

Also in 3 other countries, 5 sites

  • 3A Research - East location /ID# 283404El Paso, United StatesTaking people
  • Dermatologists of Southwestern Ohio (DSWO) /ID# 282818Fairborn, United StatesTaking people
  • Dawes Fretzin- Indianapolis /ID# 283498Indianapolis, United StatesTaking people
  • Dermatology Research Associates - Los Angeles /ID# 282821Los Angeles, United StatesTaking people
  • Ada West Research /ID# 283063Meridian, United StatesTaking people
  • Pediatric Skin Research - Miami /ID# 283281Miami, United StatesTaking people
  • Virginia Clinical Research /ID# 283797Norfolk, United StatesTaking people
  • Skin Specialists /ID# 283358Omaha, United StatesTaking people
  • Texas Dermatology and Laser Specialists /ID# 282813San Antonio, United StatesTaking people

About the trial

What the trial wants to find out

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the scalp and face, but hair loss can happen on any hair-bearing part of the body. Some treatment options are available for adults and adolescents with AA, however there is still high unmet need for systemic treatments (treatment that moves throughout the bloodstream) approved for young patients with AA. Treatments may not work for all patients or may stop working over time. Because of this, researchers are developing new AA treatments, like upadacitinib. Upadacitinib is a type of medicine called a Janus- Kinase (JAK) inhibitor and works with the body to fight the inflammation that can cause AA. In this study, different doses (amounts) of upadacitinib are being compared to treatment with placebo (looks like the study treatment but contains no medicine).

Read full original descriptionShow less

Upadacitinib is an investigational JAK inhibitor being developed for the treatment of severe alopecia areata in pediatric patients. This is a randomized, double-blind, placebo-controlled study. Participants are placed in 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Pediatric participants with a diagnosis of severe alopecia areata with SALT score ≥ 50 scalp hair loss will be enrolled. Participants will be at least 6 years old at Screening and less than 18 years old at Baseline. Approximately 300 participants will be enrolled in the study at approximately 120 sites worldwide.

Participants will receive oral doses of upadacitinib or matching placebo daily, or twice daily, for approximately 160 weeks. The study comprises a 35-day Screening Period, a 24-week placebo-controlled double-blinded treatment period (Period A), a 28-week blinded extension treatment period (Period B), a 108-week blinded long-term extension period (Period C), and a 30-day follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

The 5 groups in the trial

  • Group 1A: Upadacitinib Dose 1Treatment being tested

    Participants will receive upadacitinib Dose 1 during Period A (Baseline to Week 24) and continue the same treatment through Period B (Week 24 to Week 52) and Period C (Week 52 to Week 160).

    Treatment: Upadacitinib

  • Group 2A: Upadacitinib Dose 2Treatment being tested

    Participants will receive upadacitinib Dose 2 during Period A (Baseline to Week 24) and continue the same treatment through Period B (Week 24 to Week 52) and Period C (Week 52 to Week 160).

    Treatment: Upadacitinib

  • Group 3A: Matching PlaceboPlacebo, for comparison

    Participants will receive matching placebo during Period A (Baseline to Week 24). Participants achieving SALT score ≤ 20 at Week 24 will remain on placebo until SALT score \> 20, then switch to blinded upadacitinib. Participants with SALT score \> 20 at Week 24 will be re-randomized to upadacitinib Dose 1 or Dose 2.

    Treatment: Placebo

  • Group 1B: Upadacitinib Dose 1Treatment being tested

    Participants initially randomized to placebo in Period A with SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose 1 during Period B and continue through Period C.

    Treatment: Upadacitinib

  • Group 2B: Upadacitinib Dose 2Treatment being tested

    Participants initially randomized to placebo in Period A with SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose 2 during Period B and continue through Period C.

    Treatment: Upadacitinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Fit questions
Built from NCT07772492, who can take part
Record updated
27 October 2026