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

Официальное название

A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents

Обзор

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.

Подробное описание

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.

Вмешательства

• Препарат Placebo
  placebo subcutaneous injection Q2W until week 46.
• Препарат placebo
  placebo subcutaneous injection Q3W until week 45.

Первичные конечные точки

• Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75 [Срок оценки: at week 18 （day 127)]
• Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points [Срок оценки: at week 18 （day 127)]

Вторичные конечные точки (4)

• Percentage change in affected Body Surface Area (BSA) [Срок оценки: week 0 to week 52]
• percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores [Срок оценки: week 0 to week 52]
• Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score [Срок оценки: week 0 to week 52]
• Incidence of Adverse Events (AE) [Срок оценки: week 0 to week 52]

Критерии участия

Критерии включения

• Male or female subjects aged ≥12<18 years old, weight ≥ 30kg.
• AD diagnosed at least half a year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
• Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.

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 4 weeks or 5 halflives 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 28 центров

• The Second Affiliated Hospital of Wannan Medical College — Wuhu
• Peking University People's Hospital — Пекин
• Chongqing Traditional Chinese Medicine Hospital — Чунцин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Dongguan People's Hospital — Дунгуань
• Dermatology Hospital of Southern Medical University — Гуанчжоу
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• The First Affiliated Hospital of Jinan University — Гуанчжоу
• … и ещё 20 центров

Идентификаторы

NCT: NCT06767540 · AK120-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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