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Study of Deuruxolitinib for Severe Alopecia Areata in Adolescents

This study is looking at a medication called deuruxolitinib for adolescents (ages 12 to less than 18) who have severe alopecia areata. Alopecia areata is a condition where your immune system attacks your hair follicles, causing hair loss. To join, you must have at least 50% scalp hair loss and your hair loss episode must have lasted between 6 months and 10 years. Participants will receive either deuruxolitinib or a placebo (an inactive pill) for 24 weeks. The researchers want to see how much hair regrowth occurs and if the medication is safe. The study aims to enroll 355 participants, but its current recruitment status is unclear.

Study design
This is a double-blind, randomized, placebo-controlled study, meaning neither you nor your doctor will know if you're receiving deuruxolitinib or a placebo. It involves 355 planned participants.
What's involved
You would take deuruxolitinib or a placebo orally as tablets for 24 weeks. After this, all participants will receive deuruxolitinib for an additional 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, including hair regrowth and safety, are measured at Week 24. Participants in the open-label extension will receive treatment for 52 weeks after the initial 24-week period.

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NCT07133308

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

Recruiting
PHASE3Ages 12–17InterventionalTreatment
Sun Pharmaceutical Industries, Inc.
~355 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:DeuruxolitinibPlacebo

At a glance

Recruiting sites
64 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20
Measured over Week 24
+1 more outcome measured

Conditions

Alopecia Areata

Explore related trials

Alopecia

Where it's being run

64 sites across 30 states
Florida15
California5
Texas4
Alberta4
Georgia3
Ontario3
Colorado2
Indiana2

Who to contact

Head Regulatory Affairs
[email protected]
9122 66455645
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20Week 24

    SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).

  • Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinationsWeek 24

    Summary of participants who experience Treatment emergent adverse events (TEAEs) and serious TEAEs will be provided. An AE is defined as any untoward medical occurrence that may appear or worsen in a subject during the course of a study. Adverse events will be considered treatment-emergent if the onset is after the first dose of study drug. Summaries will be provided of participants who experience potentially clinically significant post-baseline changes in: hematology, chemistry and lipid results, vital signs (blood pressure, pulse rate, respiratory rate, temperature), electrocardiogram parameters (heart rate, PR, QT, QTcF, QRS, and RR) and physical examination findings.