NCT07250594尚未招募2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Safety and tolerability endpoint
研究概览
简要总结
- Eosinophilic asthma, a type 2 immune disorder, often involves the excessive production of type 2 cytokines.
- Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction.
- AD17002 is an intranasal self-applicable immunomodulator.
- AD17002 is safe and tolerable in all studied clinical trials.
- AD17002 elevates local type-1 interferon levels and promotes epithelial healing.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
排除标准
- •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 AD
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Formulation buffer
干预措施: Formulation buffer (Other)
Low dose (10 μg) AD17002
Experimental
containing 10 μg of AD17002
干预措施: AD17002 (Biological)
High dose (20 μg) AD17002
Experimental
containing 20 μg of AD17002
干预措施: AD17002 (Biological)
结局指标
主要结局
Safety and tolerability endpoint
时间窗: Baseline to week 17
The incidence and severity of TEAEs and serious TEAEs
次要结局
- Time to the first moderate and severe asthma exacerbations.(Baseline to week 17)
- Proportion of patients experiencing moderate and severe asthma exacerbations(Baseline to week 17)
- Number of moderate and severe asthma exacerbations(Baseline to week 17)
- Time to first asthma worsening alert.(Baseline to week 17)
- Change in pre-bronchodilator (BD) FEV1(Baseline (Week 1) to Weeks 5, 9, 13, 15, and 17)
- Change in FeNO levels(Baseline to week 17)
- Change in the ratio of weekly average PEF in the morning to predicted PEF from baseline(Baseline to week 17)
- Change in asthma control(Baseline to week 17)
- Change in blood eosinophil counts(Baseline to week 17)
- change in vital signs(Baseline to week 17)
- Change in laboratory values(Baseline to week 17)
研究者
研究点 (1)
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