NCT03201003已完成3 期
AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 35
- 主要终点
- The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.
详细描述
This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 17 years, inclusive
- •Clinical history of allergy to peanuts
- •Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L
- •Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg
- •Written informed consent from the subject's parent/guardian
- •Written assent from the subject as appropriate (per local regulatory requirements)
- •Use of effective birth control by sexually active female subjects of childbearing potential
排除标准
- •History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- •History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
- •History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
- •History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
- •History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
- •Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
结局指标
主要结局
The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.
时间窗: Approximately 9 months
The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
次要结局
- Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge(Approximately 9 months)
- Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.(Approximately 9 months)
- Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge(Approximately 9 months)
研究者
研究点 (35)
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