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Набира участници Фаза 1 NCT07205159

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Alopecia Areata

Спонсор: Forte Biosciences, Inc.

Налично на: БГ
Обобщение
This is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of FB102 in patients with severe to very severe alopecia areata (AA).
Описание
Up to approximately 32 participants who meet all the Screening eligibility criteria will be randomized in a 3:1 ratio to receive FB102, or placebo dosing to match.
Кой може да участва
Inclusion Criteria: * Males aged 18-60 years and females aged 18-75 years at Screening. * Clinical diagnosis of severe to very severe AA with ≥50% scalp hair loss (including AT or AU) confirmed by SALT score and central photo review; no other cause of hair loss. * AT = complete scalp hair loss; AU = complete scalp, facial, and body hair loss. Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria Exclusion Criteria: * Other types of alopecia (e.g., diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, androgenetic alopecia). * Other scalp diseases impacting AA assessment (e.g., psoriasis, dermatitis, tinea capitis). * Active systemic diseases causing hair loss (e.g., lupus, thyroiditis, systemic sclerosis, lichen planus, syphilis). Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
Места на провеждане 2
Австралия (1)
St Leonards
Saint Leonards , New South Wales (nsw)
NOT_YET_RECRUITING
New Zealand (1)
Auckland
Auckland , Auckland
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
23.10.2025
Крайна дата
10.03.2027
Регистрационен номер
NCT07205159
Източник
anzctr
Запитване за медицински туризъм

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