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

Condition(s) studied

Investigational drug(s) / intervention(s)

Deuruxolitinib: Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg

Placebo: Deuruxolitinib matching placebo will be dosed orally as tablets

Study summary

This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.

Eligibility

Primary outcome measure(s)

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

Trial sites (64)

+ 24 more sites — see the full list on the official registry below.

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