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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Deuruxolitinib
  Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
• Препарат Placebo
  Deuruxolitinib matching placebo will be dosed orally as tablets

Первичные конечные точки

• Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20 [Срок оценки: Week 24]
• Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations [Срок оценки: Week 24]

Вторичные конечные точки (12)

• Percentage of subjects achieving an absolute SALT score of ≤20 [Срок оценки: Weeks 4, 8, 12, 16, and 20]
• Mean percent change (ie, relative change) in SALT scores from baseline [Срок оценки: Weeks 4, 8, 12, 16, 20, and 24]
• Percentage of responders (defined as "much improved" or "very much improved") using the Clinical Global Impression of Improvement (CGI-I) [Срок оценки: Weeks 12, 16, 20, and 24]
• Percentage of responders (defined as "much improved" or "very much improved") using the Patient Global Impression of Improvement (PGI-I) [Срок оценки: Weeks 12, 16, 20, and 24]
• Mean change from baseline in the Clinical Global Impression of Severity (CGI-S) [Срок оценки: Weeks 12, 16, 20, and 24]
• Mean change from baseline in the Patient Global Impression of Severity (PGI-S) [Срок оценки: Weeks 12, 16, 20, and 24]
• Percentage of subjects achieving an absolute SALT score of ≤10 [Срок оценки: Weeks 4, 8, 12, 16, 20, and 24]
• Mean change from baseline on the Eyebrow Clinician-Reported Outcome (ClinRO) score [Срок оценки: Weeks 4, 8, 12, 16, 20, and 24]
• Mean change from baseline on the Eyelash Clinician-Reported Outcome (ClinRO) score [Срок оценки: Weeks 4, 8, 12, 16, 20, and 24]
• Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale [Срок оценки: Weeks 4, 8, 12, 16, 20, and 24]
• Mean change from baseline in the SPRO scale [Срок оценки: Weeks 4, 8, 12, 16, 20, and 24]
• Percentage of subjects achieving SALT score of ≤ 20 at Week 24 whose SPRO rating shifted from Very Dissatisfied or Dissatisfied to Very Satisfied or Satisfied [Срок оценки: Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 54 центра

• Total Skin And Beauty Dermatology Center — Birmingham
• Avacare - Cct Research - Center For Dermatology And Plastic Surgery — Scottsdale
• Dermatology Trial Associates — Bryant
• Kern Research Inc. — Bakersfield
• Center For Dermatology Clinical Research Inc. — Fremont
• Dermatology Research Associates — Los Angeles
• Palmtree Clinical Research — Palm Springs
• Paradigm Clinical Research - San Diego — San Diego
• … и ещё 46 центров

Канада · 10 центров

• Kirk Barber Research — Calgary
• Dermatology Research Institute (Calgary) — Calgary
• Alberta Dermasurgery Centre — Edmonton
• Care Clinic Ltd. — Red Deer
• Medical Arts Health Research Group - Kelowna — Kelowna
• Enverus Medical Research — Surrey
• Lynderm Research Inc. — Markham
• Dr. S. K. Siddha Medicine Professional Corporation — Newmarket
• … и ещё 2 центра

Идентификаторы

NCT: NCT07133308 · CP543.3101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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