A Multicenter, Open-Label, Functionality, Reliability and Performance Study of a Single-Use Auto-Injector With Home-administered Subcutaneous Benralizumab in Adult Patients With Severe Asthma (GRECO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 121
- 试验地点
- 26
- 主要终点
- Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home
研究概览
简要总结
The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm Benralizumab
Benralizumab administered subcutaneously every 4 weeks
干预措施: Benralizumab (Biological)
结局指标
主要结局
Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home
时间窗: Week 12, Week 16, Week 12 and 16
Patients who are still in the study is defined as patients who had been treated for the specified timepoint. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Questionnaire, and adequately passed the visual inspection and function tests.
Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional
时间窗: Week 12, Week 16
AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.
Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)
时间窗: Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16
Number (%) of AI used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on AI dispensed for patients who were treated for the specific time point. This excludes AIs dispensed but never used for the treatment or the device not returned for evaluation.
次要结局
- The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels(Baseline, Week 20, and Week 28)
- The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab(Baseline, Week 8, Week 20, and Week 28)
- The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)(Baseline until Week 28)
- Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score(Week 0 (baseline) and weeks 4, 8, 12, 16, 20)