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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,196
- 试验地点
- 122
- 主要终点
- Annualized Rate of Moderate/Severe Exacerbations
研究概览
简要总结
Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.
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)
盲法说明
This will be a double-blind study in which participants care providers investigators and outcome assessors will be blinded to the study intervention.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 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 such as:
- •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
Placebo
Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.
干预措施: Placebo (Drug)
Depemokimab
Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (SoC).
干预措施: Depemokimab (Drug)
结局指标
主要结局
Annualized Rate of Moderate/Severe Exacerbations
时间窗: From Baseline Up to Week 156
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized rate of moderate or severe exacerbations will be reported.
次要结局
- Time to First Moderate/Severe Exacerbation(From Baseline Up to Week 156)
- Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52(From Baseline up to Week 52)
- Change from Baseline in Evaluating Respiratory Symptoms (E-RS): COPD Total Score at Week 52(From Baseline up to Week 52)