A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 51
- 主要终点
- Percentage of Treatment Responders at Month 12
研究概览
简要总结
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
详细描述
The study comprised of two parts:
- In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
- In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female from 1-3 years of age;
- •Physician-diagnosed peanut allergy;
- •Peanut-specific IgE level > 0.7 kU/L;
- •Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
- •Positive DBPCFC at ≤ 300 mg peanut protein;
排除标准
- •Uncontrolled asthma;
- •History of severe anaphylaxis to peanut;
- •Prior immunotherapy to any food or other immunotherapy;
- •Generalized severe dermatologic disease;
研究组 & 干预措施
Part A Viaskin Peanut 250 mcg
干预措施: Part A Viaskin Peanut 250 mcg (Biological)
Part A Viaskin Peanut 100 mcg
干预措施: Part A Viaskin Peanut 100 mcg (Biological)
Part A Placebo
干预措施: Part A Placebo (Biological)
Part B Viaskin Peanut 250 mcg
干预措施: Part B Viaskin Peanut 250 mcg (Biological)
Part B Placebo
干预措施: Part B Placebo (Biological)
结局指标
主要结局
Percentage of Treatment Responders at Month 12
时间窗: Month 12
A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
次要结局
- Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model(Month 12)
- Change From Baseline in CRD of Peanut Protein to Month 12(Baseline (Day 1) and Month 12)
- ED of Peanut Protein at Month 12 Using ANCOVA Model(Month 12)
- Change From Baseline in ED of Peanut Protein to Month 12(Baseline (Day 1) and Month 12)
- Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge(Baseline (Day 1) and Month 12)