A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD)

Официальное название

A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD

Обзор

This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis

Подробное описание

This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.

Вмешательства

• Препарат AK120
  AK120 subcutaneous injection

Первичные конечные точки

• Incidence of adverse events(AE) [Срок оценки: week -4 to week 16]

Вторичные конечные точки (8)

• PK evaluation: maximum plasma concentration (Cmax) [Срок оценки: Baseline till last follow-up visit ( up to day 113)]
• PK evaluation: time to maximum plasma concentration (Tmax) [Срок оценки: Baseline till last follow-up visit ( up to day 113)]
• PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17 [Срок оценки: Baseline till last follow-up visit ( up to day 113)]
• Change in Eczema Area and Severity Index (EASI) scores [Срок оценки: week 0/2/4/8/12/16]
• Change in affected Body Surface Area (BSA) scores [Срок оценки: week 0/2/4/8/12/16]
• Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA) [Срок оценки: week 0/2/4/8/12/16]
• Change in Children's Dermatology Life Quality Index (CDLQI) scores [Срок оценки: week 0/2/4/8/12/16]
• Change in Patient Oriented Eczema Measure (POEM) scores [Срок оценки: week 0/2/4/8/12/16]

Критерии участия

Критерии включения

• Male or female subjects aged ≥12 <18 years old.
• Weight≥30kg at baseline.
• AD diagnosed at least half a year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.

Критерии исключения

• Acute onset of AD in 4 weeks prior to enrollment.
• Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
• Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
• Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
• Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer).
• Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Dongguan People's Hospital — Дунгуань
• The Second Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The University of Hong Kong - Shenzhen Hospital — Шэньчжэнь
• Hunan Pediatric Medical Union — Чанша
• Xiangya Hospital Central South University — Чанша
• Ning Bo No.2 Hospital — Ningbo

Идентификаторы

NCT: NCT06756126 · AK120-208

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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