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Evaluate Efficacy Safety of Deuruxolitinib in Adolescent Patients with Severe Alopecia Areata

UCI Specialty Area: Dermatology
Principal Investigator: Natasha Mesinkovska
Official Title: 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
A Study On:
Alopecia
Skin - Dermatologic

Study Description

The efficacy and safety of deuruxolitinib in adolescent subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects 12 to <18 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, participants from the Treatment Period will receive deuruxolitinib for 52 weeks.

Eligibility

  1. Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years.
  2. Between 12 to less than 18 years of age
  3. At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score greater than or equal to 50.
  4. Willing to comply with the study visits and requirements of the study protocol
  1. 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
  2. Treatment with other medications or agents within 28 days of Baseline or during the study that may affect hair regrowth or immune response.
  3. Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
  4. 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.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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