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Активно (без набиране) Фаза 1 NCT07027527

An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Atopic Dermatitis

Спонсор: Apogee Therapeutics, Inc.

Налично на: БГ
Обобщение
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).
Описание
Participants will be randomized to APG777 + APG990 or dupilumab in a 1:1 ratio. Randomization will be stratified on Day 1 according to Baseline disease severity and geographic region.
Кой може да участва
Inclusion Criteria * Have a diagnosis of AD that has been present for ≥ 1 year prior to the Screening visit and as determined by the Investigator through participant interview and/or review of the medical history. * Moderate-to-severe AD at Screening and Baseline (Day 1) visits, defined as: a) Eczema Area and Severity Index (EASI) score of ≥ 16, b) vIGA-AD score of ≥ 3, and c) AD affecting ≥10% of body surface area (BSA). * History of inadequate response to treatment with topical medications * Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1) visit. Exclusion Criteria * Participation in a prior study with APG777 or APG990. * Prior treatment with protocol-specified monoclonal antibodies (mAbs). * Has used any AD-related topical medications within 7 days prior to Baseline visit. * Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit * History of known hypersensitivity to any of the ingredients in APG777, APG990, or dupilumab. * Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments Note: Additional protocol defined Inclusion/Exclusion criteria apply
Места на провеждане 3
Австралия (1)
Investigational Site
Darlinghurst , New South Wales
Канада (1)
Investigational Site
London , Ontario
New Zealand (1)
Investigational Site
Hamilton , Waitako
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
04.06.2025
Крайна дата
01.12.2027
Регистрационен номер
NCT07027527
Източник
anzctr
Запитване за медицински туризъм

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