NCT04974970
终止
1 期
Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy
概览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Result (positive or negative) and cumulative reaction threshold at 3 months peanut oral food challenge (OFC).
概览
简要总结
The purpose of this trial is to assess the safety and efficacy of peanut immunotherapy in children and adults with peanut allergy. Participants will receive immunotherapy with peanut every 2 weeks for a period of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature.
- •Male or female subjects 12 to 45 years old at screening visit.
- •Patients with convincing history of IgE-mediated systemic allergic reaction after consumption of peanut, and specific IgE above 95% positive predictive value:
- •a. Peanut ≥ 15kU/L or Ara h 2 ≥ 5U/L
- •Patients without a convincing history of IgE-mediated systemic allergic reaction (for example only oral symptoms) after consumption of peanuts but with clear evidence of sensitization (SPT \> 3 mm and/or positive specific IgE (\> 0.1kU/l) and a positive standardized food challenge to peanut between V0 and V1.
排除标准
- •Subjects with a history of severe anaphylaxis to the incriminated food with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence).
- •Subjects with a history of systemic reaction to peanutskin prick test with commercial extract.
- •Uncontrolled asthma (Forced expiratory volume at one second (FEV1) \<70% of predicted value), active eosinophilic oesophagitis or any condition deemed incompatible by the investigator.
- •Known or suspected systemic mastocytosis.
- •Subject currently under allergen immunotherapy.
- •Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion.
- •Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study.
- •Use of immunosuppression or immunomodulatory drug (including anti-IgE or anti-Tumor necrosis factor (TNF)) within 1 year prior to inclusion in study.
- •Relative counter-indication or inability to use epinephrine auto-injector.
- •Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors.
研究组 & 干预措施
Peanut allergenic extract
Experimental
injected peanut extract.
干预措施: Peanut Immunotherapy (Drug)
结局指标
主要结局
Result (positive or negative) and cumulative reaction threshold at 3 months peanut oral food challenge (OFC).
时间窗: 3 months
An unblinded evaluation of peanut OFC cumulative reaction threshold after 3 months of peanut immunotherapy.
次要结局
- Change in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract.(3 months)
- Change in titrated skin prick test after 6 weeks and 3 months of treatment with peanut extract compared to baseline.(3 months)
- Incidence rate of treatment emergent adverse events during peanut immunotherapy(3 months)
研究者
Jean-Christoph Caubet
Principal investigator
University Hospital, Geneva
研究点 (1)
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