A Multi-dose Study on the Safety and Efficacy of Self-administered Intranasal AD17002 Treatment for Eosinophilic Asthma

Официальное название

A Phase II, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-dose Study to Investigate the Safety and Efficacy of 3-month AD17002 Treatment in Adults With Inadequately Controlled Moderate to Severe Eosinophilic Asthma

Обзор

1. Eosinophilic asthma, a type 2 immune disorder, often involves the excessive production of type 2 cytokines. 2. Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction. 3. AD17002 is an intranasal self-applicable immunomodulator. 4. AD17002 is safe and tolerable in all studied clinical trials. 5. AD17002 elevates local type-1 interferon levels and promotes epithelial healing. 6. Type-1 interferons have been demonstrated to restore immune balance and reduce eosinophilic infiltration. AD17002, an innate immune modulator, is likely to be effective as an add-on therapy to control poorly managed moderate to severe eosinophilic asthma.

Вмешательства

• Биопрепарат AD17002
  The IP, AD17002, will be provided in a container, each containing an appropriate number of IP pre-filled, self-administered syringes. Each container will be labeled as required per local requirements
• Другое Formulation buffer
  The placebo will be provided in a container, each containing an appropriate volume of formulation buffer, pre-filled syringes for self-administration. Each container will be labeled as required per local requirements

Первичные конечные точки

• Safety and tolerability endpoint [Срок оценки: Baseline to week 17]

Вторичные конечные точки (11)

• Time to the first moderate and severe asthma exacerbations. [Срок оценки: Baseline to week 17]
• Proportion of patients experiencing moderate and severe asthma exacerbations [Срок оценки: Baseline to week 17]
• Number of moderate and severe asthma exacerbations [Срок оценки: Baseline to week 17]
• Time to first asthma worsening alert. [Срок оценки: Baseline to week 17]
• Change in pre-bronchodilator (BD) FEV1 [Срок оценки: Baseline (Week 1) to Weeks 5, 9, 13, 15, and 17]
• Change in FeNO levels [Срок оценки: Baseline to week 17]
• Change in the ratio of weekly average PEF in the morning to predicted PEF from baseline [Срок оценки: Baseline to week 17]
• Change in asthma control [Срок оценки: Baseline to week 17]
• Change in blood eosinophil counts [Срок оценки: Baseline to week 17]
• change in vital signs [Срок оценки: Baseline to week 17]
• Change in laboratory values [Срок оценки: Baseline to week 17]

Критерии участия

Критерии включения

• Aged 18 to 80 on the day of signing the informed consent.
• With a diagnosis of asthma for at least 6 months.
• With pre-BD FEV1 ≥ 50% of the predicted value at the Screening visit (see section 18.6 for calculation of the predicted value for FEV1).
• Having blood eosinophil counts ≥ 150 cells/μL at the Screening visit.
• Participants who meet any of the following asthma criteria at the Screening visit:

• Moderate asthma-1 (i.e., step 3 in asthma treatment steps in adults and adolescents from 2025 GINA guideline):
• Moderate asthma-2 (i.e., step 4 in asthma treatment steps in adults and adolescents from 2025 GINA guideline):
• Severe asthma (i.e., step 5 in asthma treatment steps in adults and adolescents from 2025 GINA guideline, except for biologic therapies):

Критерии исключения

• A current smoker or quit smoking ≤ 0.5 years at Screening visit.
• With serious underlying chronic illness or severe systemic disease, including but not limited to systemic lupus erythematosus, at the investigator's discretion.
• With a current malignancy or previous history of cancer in remission for less than 5 years prior to Screening visit (Subject will not be excluded if he/she had localized carcinoma of the skin that was resected for cure).
• With chronic heart failure in New York Heart Association class III to IV.
• With clinically severe lung disease, including but not limited to cystic fibrosis, chronic bronchitis (chronic obstructive pulmonary disease other than asthma), chronic respiratory infection, lung cancer, current infection, active tuberculosis infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema.
• With arrhythmia, myocardial infarction, or stroke within the last 3 months prior to the Screening visit.
• With a recent respiratory tract infection within 4 weeks prior to the Screening visit.
• Received chronic oxygen therapy within one month prior to the Screening visit.
• With any nasal conditions that could interfere with drug absorption or confound the efficacy or safety assessments.
• Immunosuppressive treatment, including but not limited to methotrexate, troleandomycin, cyclosporine, and azathioprine within 3 months prior to the Screening visit and throughout the study.
• Use of systemic corticosteroids (including regular oral corticosteroids or intramuscular long-acting depot corticosteroids) at daily average doses greater than 7.5 mg prednisone or equivalent for the past 3 months prior to the Screening visit.
• Having or planning to be vaccinated with live (attenuated) vaccine within 1 month prior to the Screening visit and throughout the study.
• Having received immunotherapy including but not limited to monoclonal antibodies, within 3 months prior to the Screening visit and throughout the study.
• Having previously received AD17002.
• Having received other IP or investigational intervention (non-AD17002), including investigational formulations of marketed products, within the past 30 days or 5 half-lives of the medication, whichever is longer, prior to the Screening visit.
• Requiring add-on biologic therapy, such as anti-IgE, anti-IL-5/5R, anti-IL-4Rα, and anti-thymic stromal lymphopoietin treatment.
• Having experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with high-dose systemic corticosteroids (prednisolone ≥ 40 mg/day or equivalent for ≥ 5 days) within 1 month prior to the Screening visit.
• Having a history of anaphylaxis with cardiorespiratory symptoms, triggered by prior immunotherapy, an unknown cause, or an inhalant allergen.
• Being pregnant or breastfeeding.
• Planning to become pregnant or breastfeed throughout the study.
• A known history of allergy, hypersensitivity, or intolerance to any component of IP, rescue medications, or self-injectable epinephrine.
• Any clinically significant abnormalities in physical examination, vital signs, hematology, biochemistry, or urinalysis that, in the investigator's opinion, may pose a risk to the patient's safety, affect study outcomes, or hinder the patient's ability to complete the study.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Advagene Biopharma — Taipei

Идентификаторы

NCT: NCT07250594 · ADV-EASP212

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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