NCT03126227已完成3 期
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 134
- 主要终点
- Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
详细描述
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children 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
- Triple (Participant, Care Provider, Investigator)
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
- •Ages 4 to 17 years, inclusive
- •History of physician-diagnosed peanut allergy that includes allergic signs and symptoms within two hours of known oral exposure to peanut
- •Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14 kUA/L at screening
- •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
- •Subjects in whom the clinical diagnosis of peanut allergy is uncertain
- •Severe or uncontrolled asthma
- •History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- •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
Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events
时间窗: Approximately 6 months
Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.
次要结局
- Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment(Approximately 6 months)
- Frequency of Premature Discontinuation of Dosing Due to Adverse Events(Approximately 6 months)
- Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events(Approximately 6 months)
- Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing(Approximately 6 months)
- Frequency of Anaphylaxis as Defined in the Protocol(Approximately 6 months)
- Frequency of Epinephrine Use as Rescue Medication(Approximately 6 months)
- Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods(Approximately 6 months)
- Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11(Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months))
- Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17(Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months))
- Frequency of Adverse Events That Led to Early Withdrawal(Approximately 6 months)
研究者
研究点 (134)
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