Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 104
- 试验地点
- 50
- 主要终点
- Percentage of Participants With Asthma Exacerbation
研究概览
简要总结
Primary Objective:
To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma.
Secondary Objectives:
- To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
- To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
详细描述
The total duration of the study period per participant was 20-22 weeks broken down as follows:
- Screening period: up to 14 days,
- Treatment period: 12 weeks,
- Follow-up period: 6-8 weeks.
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
- 18 Years 至 65 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
Placebo (for Dupilumab)
Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Placebo (for Dupilumab) (Drug)
Placebo (for Dupilumab)
Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Fluticasone/Salmeterol combination therapy (Drug)
Placebo (for Dupilumab)
Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Fluticasone monotherapy (Drug)
Placebo (for Dupilumab)
Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Albuterol (Drug)
Placebo (for Dupilumab)
Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Levalbuterol (Drug)
Dupilumab 300 mg qw
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Dupilumab (Drug)
Dupilumab 300 mg qw
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Fluticasone/Salmeterol combination therapy (Drug)
Dupilumab 300 mg qw
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Fluticasone monotherapy (Drug)
Dupilumab 300 mg qw
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Albuterol (Drug)
Dupilumab 300 mg qw
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
干预措施: Levalbuterol (Drug)
结局指标
主要结局
Percentage of Participants With Asthma Exacerbation
时间窗: Baseline up to Week 12
An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.
次要结局
- Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12(Baseline, Week 12)
- Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12(Baseline, Week 12)
- Change From Baseline in Peak Expiratory Flow (PEF) to Week 12(Baseline, Week 12)
- Change From Baseline in Morning Asthma Symptom Scores to Week 12(Baseline, Week 12)
- Percentage of Participants With Composite Asthma Events(Baseline up to Week 12)
- Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12(Baseline, Week 12)
- Change From Baseline in Evening Asthma Symptom Scores to Week 12(Baseline, Week 12)
- Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12(Baseline up to Week 12)
- Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12(Baseline, Week 12)
- Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12(Baseline, Week 12)