NCT05037929已完成2 期
A Phase IIb, 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
- 2 期
- 状态
- 已完成
- 入组人数
- 1,334
- 试验地点
- 351
- 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, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented physician diagnosis of COPD for at least 12 months
- •History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
- •Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
- •Modified Medical Research Council (dyspnea scale) (mMRC) score >=2
- •Current or former smoker with a minimum of 10 pack-year history
- •History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA
排除标准
- •Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
- •History of clinically significant pulmonary disease other than COPD
- •History of long-term treatment with oxygen at >4.0 liters/minute
- •Lung volume reduction surgery or procedure within 12 months prior to screening
- •Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
- •History of lung transplant
- •Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
- •Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
- •Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks 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
Astegolimab Q2W
Experimental
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).
干预措施: Astegolimab (Drug)
Astegolimab Q4W
Experimental
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
干预措施: Astegolimab (Drug)
Placebo
Placebo Comparator
Participants will receive SC placebo Q2W.
干预措施: Placebo (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: Baseline up to Week 52
次要结局
- Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period(Baseline up to Week 52)
- 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(Baseline to Week 52)
- Proportion of SGRQ-C Responders at Week 52(Baseline to Week 52)
- Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52(Baseline to Week 52)
- Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52(Baseline to Week 52)
- Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period(Baseline up to Week 52)
- Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52(Baseline to Week 52)
研究者
研究点 (351)
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