Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 11
- 主要终点
- Health-related Quality of Life
研究概览
简要总结
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.
详细描述
This is a phase 3b, randomized, open label, European study of the HRQOL of AR101 in combination with standard of care compared with standard of care alone in approximately 200 peanut-allergic subjects aged 4 to 17 years, inclusive.
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
- None
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 through 17 years
- •History of physician diagnosed IgE mediated peanut allergy with characteristic signs and symptoms
- •Positive SPT for peanut
- •Positive serum IgE to peanut
- •Written informed consent from the subject's parent/guardian
- •Written assent from the subject as appropriate
- •Use of effective birth control by sexually active female subjects of childbearing potential
排除标准
- •Uncertain clinical diagnosis of peanut allergy
- •History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
- •Severe persistent asthma or uncontrolled mild or moderate asthma
- •History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, severe gastroesophageal reflux disease, symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
- •History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
- •History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- •History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
研究组 & 干预措施
Group 1 (AR101 Treatment + standard of care)
Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.
干预措施: AR101 (Biological)
Group 2 (Standard of Care Treatment)
Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.
结局指标
主要结局
Health-related Quality of Life
时间窗: 18 months per subject, approximately 30 months for the study
The primary analyses will use scores from a family of proxy- and self-reported disease-specific HRQOL measures to assess the HRQOL of peanut-allergic subjects treated with AR101 or standard of care alone during the study. The relevant disease-specific HRQOL questionnaires include the FAQLQ-PF (parent form), FAQLQ-PFT (parent form teenager), FAQLQ-CF (child form), FAQLQ-TF (teenager form), FAIM-PF (parent form), FAIM-PFT (parent form teenager), FAIM-CF (child form), and FAIM-TF (teenager form).
次要结局
未报告次要终点