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

NCT07772492 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: M24-7252025-525048-16-002025
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 9

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

Keywords

Alopecia Areata; Severe Alopecia Areata; Upadacitinib; ABT-494

Outcome Measures

Primary Outcomes (2)

• 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.

  The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.

  At Week 24

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Week 160

Secondary Outcomes (13)

• Percentage of Participants Achieving SALT Score <= 10

  At Week 24

• Percentage of Participants Achieving SALT Score <= 20

  At Week 12

• Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1

  At Week 24

• Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyelash Hair Loss of 0 or 1

  At Week 24

• Percentage of Participants Achieving SALT Score 0

  AT Week 24

Study Arms (5)

Group 1A: Upadacitinib Dose 1

EXPERIMENTAL

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).

Drug: Upadacitinib

Group 2A: Upadacitinib Dose 2

EXPERIMENTAL

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).

Drug: Upadacitinib

Group 3A: Matching Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Group 1B: Upadacitinib Dose 1

EXPERIMENTAL

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.

Drug: Upadacitinib

Group 2B: Upadacitinib Dose 2

EXPERIMENTAL

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.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Oral

Group 1A: Upadacitinib Dose 1; Group 1B: Upadacitinib Dose 1; Group 2A: Upadacitinib Dose 2; Group 2B: Upadacitinib Dose 2

Placebo DRUG

Oral

Group 3A: Matching Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

Dermatology Research Associates - Los Angeles /ID# 282821

Los Angeles, California, 90045, United States

RECRUITING

Pediatric Skin Research - Miami /ID# 283281

Miami, Florida, 33156, United States

RECRUITING

Ada West Research /ID# 283063

Meridian, Idaho, 83646, United States

RECRUITING

Dawes Fretzin- Indianapolis /ID# 283498

Indianapolis, Indiana, 46250, United States

RECRUITING

Skin Specialists /ID# 283358

Omaha, Nebraska, 68144, United States

RECRUITING

Dermatologists of Southwestern Ohio (DSWO) /ID# 282818

Fairborn, Ohio, 45324, United States

RECRUITING

3A Research - East location /ID# 283404

El Paso, Texas, 79925, United States

RECRUITING

Texas Dermatology and Laser Specialists /ID# 282813

San Antonio, Texas, 78218, United States

RECRUITING

Taipei Veterans General Hospital /ID# 282900

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (8); TW (1)