NCT05595642进行中（未招募）3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,290
- 试验地点
- 787
- 主要终点
- Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
研究概览
简要总结
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented COPD diagnosis for ≥ 12 months
- •History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
- •Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening
- •Post-bronchodilator FEV1/FVC < 0.70 at screening
- •Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
- •Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
- •On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
- •Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD
排除标准
- •Current documented diagnosis of asthma
- •History of clinically significant pulmonary disease other than COPD
- •Diagnosis of 1-antitrypsin deficiency
- •History of long-term treatment with oxygen at > 4.0 liters/minute
- •Lung volume reduction surgery or procedure within 12 months prior to screening
- •Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
- •History of lung transplant
- •Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
- •Upper or lower respiratory tract infection within 4 weeks prior to or during screening
- •Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
- •Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
- •Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening
研究组 & 干预措施
Placebo SC Q2W
Placebo Comparator
Participants will receive SC placebo Q2W
干预措施: Placebo (Drug)
Astegolimab SC Q4W
Experimental
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
干预措施: Astegolimab (Drug)
Astegolimab SC Q2W
Experimental
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
干预措施: Astegolimab (Drug)
结局指标
主要结局
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
时间窗: 52 weeks
次要结局
- Annualized rate of severe COPD exacerbations over the 52-week treatment period(52 weeks)
- Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score(Week 52)
- Time to first moderate or severe COPD exacerbation during the 52-week treatment period(52 weeks)
- Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52(Week 52)
- Proportion of participants with improvement in HRQoL at Week 52(Week 52)
- Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52(Week 52)
研究者
研究点 (787)
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