A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects With Moderate-to-severe Chronic Obstructive Pulmonary Disease and Sputum Eosinophilia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 31
- 主要终点
- Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
研究概览
简要总结
To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults.
详细描述
To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (greater than or equal to [>=] 3.0 percent [%] sputum eosinophilia in the previous 12 months or at Screening) in sputum compared to placebo.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 40-85 years at the time of Screening
- •Written informed consent obtained from the subject prior to performing any protocol related procedures
- •Documented history of 1 or more Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
- •Current smoker or ex-smoker with a tobacco history of greater than or equal to (>=) 10 pack-years
- •Adequate contraception from screening through end of trial
- •Able to read and write.
排除标准
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- •Pregnant, breastfeeding, or lactating women
- •Known history of allergy or reaction to any component of the investigational product formulation
- •History of anaphylaxis to any other biologic therapy
- •Donation or transfusion of blood, plasma or platelets within the past 3 months prior to Screening
- •Other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study
- •Fever greater than (>) 37.0 degree Centigrade (98.6 degree Fahrenheit) at Screening
- •Receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study
- •Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus 1or 2 (HIV-1 or HIV 2)
- •History of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation
- •Past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to Screening
- •Subjects participating in, or scheduled for, an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part)
- •Current diagnosis of asthma according to Global Initiative for Asthma guidelines
- •Previous treatment with MEDI-563.
结局指标
主要结局
Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
时间窗: Day 1 up to 393
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.
次要结局
- Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)(Day 1 up to 393)
- Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)(Day 1 up to 393)
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(Day 1 up to 561)
- Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)(Day 1 up to 393)
- Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393(Baseline, Day 393)
- Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score(Day 393)
- Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393(Baseline, Day 393)
- Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393(Day 393)
- Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393(Baseline, Day 393)