One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 378
- 试验地点
- 81
- 主要终点
- Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
Primary Objective:
- To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- To evaluate the efficacy of dupilumab in children of 6 to <12 years of age with uncontrolled persistent asthma in the Japan sub-study.
Secondary Objectives:
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To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
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To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to:
-
Systemic exposure.
-
Anti-drug antibodies (ADAs).
-
Biomarkers.
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To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study
-
To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to:
-
Systemic exposure,
-
Anti-drug antibodies (ADAs),
-
Biomarkers
详细描述
Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up.
Japan substudy:
Study duration per participant is approximately 68 weeks including 3-5 weeks screening period, 52 weeks treatment period and 12 weeks post treatment follow-up period.
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
- 6 Years 至 11 Years（Child）
- 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
Dupilumab
Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks
干预措施: Dupilumab (SAR231893/REGN668) (Drug)
Dupilumab
Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks
干预措施: Asthma controller therapies (incl. prednisone/prednisolone) (Drug)
Dupilumab
Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks
干预措施: Asthma reliever therapies (Drug)
结局指标
主要结局
Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
时间窗: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.
Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Baseline (Day 1) to Week 12
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available measurement prior to the first study treatment dose if the participant was treated, or the last available value up to enrollment if the participant was not exposed to study treatment in the current study.
次要结局
- Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events(From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks)
- Annualized Rate of Severe Asthma Exacerbation Events During the 52-Week Treatment Period(Up to Week 52)
- Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time(Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64)
- Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time(Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64)
- Change From Baseline in Forced Vital Capacity (FVC) Over Time(Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64)
- Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time(Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64)
- Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time(Baseline (Day 1) and Weeks 2, 8, 12, 24, 52 and 64)
- Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time(Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64)
- Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time(Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64)
- Serum Concentrations of Dupilumab(Weeks 12, 24, 52 and 64)
- Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab(From first dose of study treatment (Day 1) to Week 64)
- Main Study: Percent Change From Baseline in Blood Eosinophil Count at Week 64(Baseline (Day 1) to Week 64)
- Percent Change From Baseline in Total Immunoglobulin (Ig) E in Serum at Week 64(Baseline (Day 1) to Week 64)
- Japan Sub-study: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 64(Baseline (Day 1) to Week 64)