2025-521108-23-00招募中3 期
A multicenter, randomized, double-blind, parallel group, placebo-controlled study of the efficacy and safety of early depemokimab initiation as add-on treatment in COPD patients with type 2 inflammation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 549
- 试验地点
- 78
- 主要终点
- Annualized rate of moderate/severe exacerbations.
研究概览
简要总结
To evaluate the efficacy of depemokimab compared with placebo
研究设计
- 分配方式
- Na
- 主要目的
- Followup/withdraw
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or eligible female participants
- •Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
- •Moderate to severe COPD, defined as - A clinically documented history of COPD for at least 1 year - A post-salbutamol Forced expiratory volume in one second (FEV1)/ Forced vital capacity (FVC) ratio of less than (<)0.70 and a post-salbutamol FEV1 greater than (>)30 percent (%) and <80% predicted normal values
- •Elevated risk for exacerbations, defined as - A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and - The presence of risk factors for future exacerbations/deterioration : ▪ Modified Medical Research Council (mMRC) dyspnea score >= 2 ▪ COPD Assessment Test (CAT) >= 15 ▪ Post-bronchodilator FEV1 < 50% predicted ▪ Chronic bronchitis
- •Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening.
- •Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist [LABA] or LABA+ Long-acting muscarinic receptor antagonist [LAMA]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months
- •Body mass index (BMI) >=16 kilograms per square meter (kg/m^2)
排除标准
- •The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded - Participants with a current or prior physician diagnosis of asthma - Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
- •Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
- •COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
- •COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1
- •Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure
- •Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1
- •Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded
- •Continuous oxygen: Participants requiring oxygen supplementation for COPD
研究组 & 干预措施
Novolizer Salbutamol 100 microgrammes/dose, poudre pour inhalation
Auxiliary
干预措施: Novolizer Salbutamol 100 microgrammes/dose, poudre pour inhalation (Drug)
Sterile 0.9% (w/v) sodium chloride solution in single-use PFS
Placebo
干预措施: Sterile 0.9% (w/v) sodium chloride solution in single-use PFS (Drug)
结局指标
主要结局
Annualized rate of moderate/severe exacerbations.
Annualized rate of moderate/severe exacerbations.
次要结局
- Time to first moderate/severe exacerbation.
- Change from baseline in SGRQ total score (measured using the SGRQ-C) at Week 52.
- Change from baseline in E-RS: COPD total score at Week 52.
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (78)
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