A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD With Type 2 Inflammation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 155
- 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 COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.
详细描述
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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 is a double-blind study neither the participants the caregivers the researchers nor the people assessing the outcomes know which treatment is being given to whom.
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
- •Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the Informed consent
- •Elevated Blood Eosinophil Count (BEC)
- •Moderate to severe COPD with frequent exacerbations, defined as:
- •A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
- •A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of < 0.70 and a post-bronchodilator FEV1 >30 percent (%) and <= 80% predicted normal values
- •A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
- •COPD assessment test (CAT) score >=10 at Visit 1
- •Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years.
- •Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1
- •Body mass index (BMI) >=16 kilogram per square meter (kg/m^2)
- •Male and eligible female participants
排除标准
- •The following subjects are excluded:
- •Participants with a current or prior physician diagnosis of asthma
- •Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease
- •Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening 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 Screening Visit 1
- •Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day
- •Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
- •Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP])
- •Unstable cardiovascular disease or arrhythmia
- •Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)
研究组 & 干预措施
Depemokimab
Participants will be administered subcutaneous (SC) injection of Depemokimab along with standard of care (SoC).
干预措施: Depemokimab (Drug)
Placebo
Participants will be administered placebo along with SoC.
干预措施: Placebo (Drug)
结局指标
主要结局
Annualized Rate of Moderate/Severe Exacerbations
时间窗: From Baseline up to Week 104
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 (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.
次要结局
- Time to First Moderate/Severe Exacerbation(From Baseline up to Week 104)
- 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 in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 52(From Baseline up to Week 52)
- Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization(From Baseline up to Week 104)
- Annualized Rate of Severe Exacerbations(From Baseline up to Week 104)