Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Deuruxolitinib, Placebo.
- Кому может быть актуально
- Состояния в реестре: Alopecia Areata. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Япония
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adult Patients With Severe Alopecia Areata With an Open-Label Extension Period
Обзор
This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.
Подробное описание
The efficacy and safety of deuruxolitinib in adult 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 between 18 and 65 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, all 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 for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks
Первичные конечные точки
- Percentage of subjects achieving an absolute SALT score of 20 or less [Срок оценки: Week 24]
Вторичные конечные точки (12)
- Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale [Срок оценки: Week 24]
- Percentage of subjects achieving an absolute SALT score of 20 or less [Срок оценки: Weeks 12, 16, and 20]
- 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 CGI-I [Срок оценки: Weeks 12, 16, 20, and 24]
- Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I [Срок оценки: Weeks 12, 16, 20, and 24]
- Change from baseline in CGI-S [Срок оценки: Weeks 12, 16, 20, and 24]
- Change from baseline in PGI-S [Срок оценки: Weeks 12, 16, 20, and 24]
- Percentage of subjects achieving at least a 75% relative reduction in SALT score from baseline [Срок оценки: Weeks 12 and 24]
- Percentage of subjects achieving at least a 90% relative reduction in SALT score from baseline [Срок оценки: Weeks 12 and 24]
- Change from baseline in the Eyebrow Clinician-Reported Outcome (ClinRO) score [Срок оценки: Weeks 12 and 24]
- Change from baseline in the Eyelash Clinician-Reported Outcome (ClinRO) score [Срок оценки: Weeks 12 and 24]
- Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale [Срок оценки: Weeks 12, 16, and 20]
Критерии участия
Критерии включения
- Written informed consent has been obtained.
- Japanese subjects with severe alopecia areata who are between 18 and 65 years of age, inclusive, at the time of informed consent.
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months.
- SALT score of 50 or more at both Screening and Baseline.
Критерии исключения
- Treatment with systemic immunosuppressive medications or agents, including Janus kinase inhibitors, within 4 months prior to randomization.
- Treatment with biologics within 6 months prior to Screening.
- Positive test results for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at Screening.
- History of active tuberculosis, a positive interferon gamma release assay at Screening, or evidence of tuberculosis-related lesions on chest radiography.
- Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.
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
Япония · 18 центров
- Study Site 102 — Asahikawa
- Study Site 117 — Bunkyō City
- Study Site 119 — Ebina
- Study Site 101 — Hamamatsu
- Study Site 116 — Ishikawa
- Study Site 112 — Kitakyushu
- Study Site 118 — Kōtoku
- Study Site 110 — Kurashiki
- … и ещё 10 центров
Идентификаторы
NCT: NCT07617597 · CTP-543-25-01JP · jRCT2031260062