NCT01412736已完成2 期
A Phase IIa , Double-blind, Placebo-controlled Dose-ranging Study to Evaluate the Efficacy and Safety of KHK4563 in Adults With Uncontrolled, Suspected Eosinophilic Asthma
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
- 106
- 主要终点
- evaluation of the effect of multiple-dose subcutaneous(SC) administration of benralizumab on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
研究概览
简要总结
This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 through 75 years at the time of Week -3 visit.
- •Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- •Physician prescribed daily use of medium-dose or high-dose ICS plus LABA or any combination of sequential dosing of either medium-dose or high-dose ICS/LABA for at least 12 months prior to Week -3 visit. Dose must be stable for at least 30 days prior to Week -3 visit.
- •At least 2, but not more than 6, documented asthma exacerbations in the 12 months prior to Week -3 visit that required use of a systemic corticosteroid burst.
- •Exclusion Criteria
- •Any condition (eg, any eosinophilic lower respiratory disease other than asthma, Churg-Strauss syndrome, hypereosinophilic syndrome, eosinophilic bronchitis, eosinophilic pneumonia, chronic obstructive pulmonary disease (COPD), bronchiectasis or cystic fibrosis (CF)) that, in the opinion of the investigator or Medical Expert, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- •Any clinically relevant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
- •Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to Week -3 visit or during the screening period.
排除标准
- 未提供
研究组 & 干预措施
2mg
Experimental
sterile lyophilized formulation, 2mg
干预措施: KHK4563 (Drug)
20mg
Experimental
sterile lyophilized formulation, 20mg
干预措施: KHK4563 (Drug)
100mg
Experimental
sterile lyophilized formulation, 100mg
干预措施: KHK4563 (Drug)
Placebo
Placebo Comparator
two SC administration on day 1
干预措施: Placebo (Drug)
结局指标
主要结局
evaluation of the effect of multiple-dose subcutaneous(SC) administration of benralizumab on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
时间窗: Immediately following the first administration of study drug through Study Week 52.
annual asthma exacerbation rate
次要结局
- Immunogenicity by serum incidence rate of positive anti-drug antibody(From first administration of study drug through Study Week 68)
- Number of participants with Adverse Events as a Measure of Safety and Tolerability(From first administration of study drug through Study Week 68.)
- Asthma control as assessed by ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)(From first administration of study drug through Study Week 52.)
- Time Profiles of Serum Concentration(From first administration of study drug through Study Week 68)
- Pulmonary function as assessed by Forced Expiratory Volume in 1 Second (FEV1) and Peak Expiratory flow (PEF)(From first administration of study drug through Study Week 52.)
研究者
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