NCT04056299终止2 期
Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 22
- 主要终点
- Proportion of Subjects Tolerating a Single Highest Dose of at Least 1000 mg Dried Egg White Protein With no More Than Mild Symptoms at the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
研究概览
简要总结
To determine the efficacy and safety of AR201 in a characterized oral desensitization immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.
详细描述
This is a phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR201 in a CODIT regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive. The study was conducted at 8 sites in the United States.
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)
盲法说明
Double-Blinded
入排标准
- 年龄范围
- 4 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 26 years, inclusive
- •Written informed consent from subjects, as appropriate per local requirements, and parent/guardian
- •Written assent from subjects who are minors, as appropriate per local requirements
- •History of physician-diagnosed hen egg allergy
- •Elevated egg specific IgE and/or mean wheal diameter on SPT to egg
- •Experience dose-limiting symptoms at or before the 300 mg challenge dose of dried egg white protein on Screening DBPCFC
- •Use of effective birth control by sexually active female subjects of childbearing potential
排除标准
- •History of severe or life-threatening anaphylaxis within 60 days before screening
- •History of non-IgE mediated hen egg allergy such as food protein-induced enterocolitis syndrome (FPIES)
- •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 unknown etiology
- •History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
- •History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) which may require a change in immunosuppressive medication regimen or chronic corticosteroid use
- •History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- •Developing dose-limiting symptoms to placebo challenge during the Screening DBPCFC
- •Having the same place of residence as another subject in the study
- •Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
结局指标
主要结局
Proportion of Subjects Tolerating a Single Highest Dose of at Least 1000 mg Dried Egg White Protein With no More Than Mild Symptoms at the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
时间窗: 9-12 months
次要结局
- Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC(9-12 months)
研究者
研究点 (22)
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