Recruiting
Phase 3

Upadacitinib

Sponsor:

AbbVie

Code:

NCT07772492

Conditions

Severe Alopecia Areata

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Upadacitinib

Placebo

Study Details

Brief summary:

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).

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.

Conditions

Severe Alopecia Areata

Study ID

NCT07772492

Start date

Aug 24, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1A: Upadacitinib Dose 1

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).

experimental: Group 2A: Upadacitinib Dose 2

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).

placebo comparator: Group 3A: Matching Placebo

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.

experimental: Group 1B: Upadacitinib Dose 1

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.

experimental: Group 2B: Upadacitinib Dose 2

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.

Interventions

Upadacitinib

Oral

Placebo

Oral

Primary outcome measure

  • Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20, defined as less than or equal to 20% scalp hair loss. [ Time Frame: At Week 24 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 160 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Dermatology Research Associates - Los Angeles /ID# 282821

Recruiting

Los Angeles, California, United States, 90045

Pediatric Skin Research - Miami /ID# 283281

Recruiting

Miami, Florida, United States, 33156

Ada West Research /ID# 283063

Recruiting

Meridian, Idaho, United States, 83646

Dawes Fretzin- Indianapolis /ID# 283498

Recruiting

Indianapolis, Indiana, United States, 46250

Skin Specialists /ID# 283358

Recruiting

Omaha, Nebraska, United States, 68144

Dermatologists of Southwestern Ohio (DSWO) /ID# 282818

Recruiting

Fairborn, Ohio, United States, 45324

3A Research - East location /ID# 283404

Recruiting

El Paso, Texas, United States, 79925

Texas Dermatology and Laser Specialists /ID# 282813

Recruiting

San Antonio, Texas, United States, 78218

Virginia Clinical Research /ID# 283797

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

AbbVie

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

  • Alopecia Areata
  • Severe Alopecia Areata
  • Upadacitinib
  • ABT-494

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.