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Deuruxolitinib for adolescents with severe alopecia areata

A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients With Severe Alopecia Areata With an Open-label Extension Period

PHASE3 · Sun Pharmaceutical Industries Limited · NCT07133308

This trial will see if deuruxolitinib can safely help adolescents aged 12 to 17 who have lost at least half their scalp hair from alopecia areata.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment355 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorSun Pharmaceutical Industries Limited (industry)
Drugs / interventionsdeuruxolitinib
Locations64 sites (Birmingham, Alabama and 63 other locations)
Trial IDNCT07133308 on ClinicalTrials.gov

What this trial studies

Adolescents 12 to <18 years with at least 50% scalp hair loss (SALT ≥50) are randomized in a double-blind, placebo-controlled 24-week treatment period to receive deuruxolitinib or placebo. After the randomized period, participants may enter a 52-week open-label extension in which all receive deuruxolitinib. Key exclusions include active scalp inflammatory conditions that interfere with assessment, recent use of other hair-regrowth or immunomodulatory therapies, and significant medical or psychiatric comorbidities. The study tracks hair regrowth measures and safety outcomes during treatment and long-term exposure.

Who should consider this trial

Good fit: Ideal candidates are 12–17-year-olds with alopecia areata causing at least 50% scalp hair loss for between 6 months and 10 years who can attend study visits and meet safety requirements.

Not a fit: Patients with active scalp conditions that affect hair assessment, recent immune- or hair-growth therapies, significant medical or psychiatric conditions, or who are pregnant or nursing are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the treatment could restore scalp hair and improve daily life for adolescents with severe alopecia areata.

How similar studies have performed: Other oral JAK inhibitors have produced hair regrowth in alopecia areata patients, so this approach has prior supportive evidence although deuruxolitinib in adolescents is being specifically tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years.
* Between 12 to \<18 years of age
* At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50.
* Willing to comply with the study visits and requirements of the study protocol

Exclusion Criteria:

* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis at Screening and/or Baseline
* Treatment with other medications or agents within 28 days of Baseline or during the study that may affect hair regrowth or immune response.
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
* Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.

Where this trial is running

Birmingham, Alabama and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Alopecia Areata

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.