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

Conditions

• Severe Alopecia Areata

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  Oral
• Placebo — DRUG
  Oral

Study Details

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.

Key Dates

First listed

Aug 19, 2026

Start date

Aug 30, 2026

Status verified

Aug 2026

Primary completion

Mar 31, 2032

Completion

Mar 31, 2032

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (3)

Find similar trials in Omaha, NE

Related Studies

• A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
  PHASE3 · Recruiting · Pfizer · Encinitas, California