jRCT2071250019招募中不适用
A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and long-term safety of dupilumab in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi K.K.
- 入组人数
- 90
- 主要终点
- Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 2age old over 至 6age old not（—）
- 性别
- All
入选标准
- •Participant must be 2 to <6 years of age.
- •Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic inhaled corticosteroids (ICS) for at least 3 months with stable use of at least low dose ICS for >=1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze.
- •At least one additional major criterion from the modified asthma predictive index:
- •a) Physician diagnosed Atopic Dermatitis,
- •b) Allergic sensitization to at least 1 aeroallergen (with a positive serum immunoglobulin E [IgE] defined as a value >=0.35 kU/L).
- •OR 2 minor criteria:
- •c) Wheezing unrelated to colds,
- •d) Peripheral blood eosinophilia >=4%,
- •e) Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE >0.35 kU/L).
- •Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study-related procedures.
- •Parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements.
- •Participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires.
- •Body weight at screening and randomization >5 kg and <30 kg.
- •Parents or caregivers or legal guardian capable of giving signed informed consent.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Severe asthma with the need for chronic oral/systemic corticosteroid use (>1 month continuous) at the time of screening enrollment.
- •History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient.
- •History of prematurity (<34 weeks gestation).
- •Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.
- •History of life-threatening asthma (eg, requiring intubation).
结局指标
主要结局
Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period
时间窗: Baseline through Week 52
Annualized rate of severe asthma exacerbations during the 52-week treatment period.
Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and adverse events (AEs) leading to permanent treatment discontinuation
时间窗: Week 52 through Week 116
Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.
次要结局
未报告次要终点
研究者
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