A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 486
- 试验地点
- 67
- 主要终点
- Change in pre-bronchodilator forced expiratory volume (FEV1)
研究概览
简要总结
Primary Objective:
To evaluate the efficacy of dupilumab in patients with persistent asthma
Secondary Objectives:
- To evaluate the safety and tolerability of dupilumab
- To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life
- To evaluate dupilumab systemic exposure and immunogenicity
详细描述
The total duration of study per patient is approximately 40 weeks, including 3 to 5 weeks of screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, 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
Placebo for dupilumab
For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose
干预措施: Asthma Reliever Therapies (Drug)
Dupilumab
For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2
干预措施: Dupilumab SAR231893 (Drug)
Dupilumab
For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2
干预措施: Asthma Controller Therapies (include prednisone/prednisolone) (Drug)
Dupilumab
For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2
干预措施: Asthma Reliever Therapies (Drug)
Placebo for dupilumab
For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose
干预措施: Placebo (Drug)
Placebo for dupilumab
For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose
干预措施: Asthma Controller Therapies (include prednisone/prednisolone) (Drug)
结局指标
主要结局
Change in pre-bronchodilator forced expiratory volume (FEV1)
时间窗: Baseline to Week 12
Absolute change from baseline in pre-bronchodilator FEV1 at Week 12
次要结局
- Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit(During the 24-week placebo-controlled treatment period)
- Morning/evening asthma symptom score (e-diary)(Baseline to Week 24)
- Change from baseline in Asthma Control Questionnaire (ACQ)-5 score(Baseline to Week 24)
- Change from baseline in ACQ-7 score(Baseline to Week 24)
- Nocturnal awakenings (e-diary)(Baseline to week 24)
- Annualized rate of severe exacerbation events(During the 24-week placebo-controlled treatment period)
- Percent change from baseline in pre-bronchodilator FEV1(Baseline to Week 12)
- Annualized rate of loss of asthma control (LOAC) event(During the 24-week placebo-controlled treatment period)
- Time to first severe exacerbation event(During the 24-week placebo-controlled treatment period)
- Time to first LOAC(During the 24-week placebo-controlled treatment period)
- Use of daily puffs of rescue medication(Baseline to Week 24)
- Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (≥12 years) (AQLQ+12)(Baseline to Week 24)
- Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L)(Baseline to Week 24)
- Assessment of adverse events (AEs)(Baseline to week 36)