A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis

Официальное название

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate to Severe Atopic Dermatitis

Обзор

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.

Вмешательства

• Биопрепарат AK139 and placebo
  AK139 plus placebo regimen 1-subcutaneous injection.
• Биопрепарат AK139
  AK139 regimen 2-subcutaneous injection.
• Биопрепарат AK139 and placebo
  AK139 plus placebo regimen 3-subcutaneous injection.
• Биопрепарат AK139
  AK139 regimen 4-subcutaneous injection.
• Биопрепарат AK139 and placebo
  AK139 plus placebo regimen 5-subcutaneous injection.
• Биопрепарат AK139 and placebo
  AK139 plus placebo regimen 6-subcutaneous injection.
• Биопрепарат Placebo
  Placebo-subcutaneous injection

Первичные конечные точки

• Incidence and severity grading of Adverse Events (AE)(applicable to Part 1) [Срок оценки: Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group).]
• Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2) [Срок оценки: at week 16]

Вторичные конечные точки (4)

• Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline [Срок оценки: Up to Week 24]
• Percentage change in affected Body Surface Area (BSA) [Срок оценки: Up to week 24]
• Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores [Срок оценки: Up to week 24]
• Percentage changes in the Dermatology Life Quality Index (DLQI) score [Срок оценки: Up to week 24]

Критерии участия

Критерии включения

• Able to understand the study and voluntarily sign the ICF.
• Atopic dermatitis (AD) diagnosed at least 6 months before screening.
• Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline.
• A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.
• Inadequate response or intolerance to prior topical therapy for AD.
• The patients agree to use highly effective contraception methods from the moment of signing of the ICF to 90 days after the last dose of the investigational product.

Критерии исключения

• Acute onset of AD within the first 4 weeks of randomization.
• Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy or other systemic therapies used for AD within the 4 weeks before randomization.
• Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
• Received or planned to receive live vaccine treatment within the 12 weeks before randomization or during the study period.
• Received allergen specific immunotherapy within the 12 weeks before randomization.
• Have a history of allergies to any component of AK139 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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07502222 · AK139-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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