Oral Immunotherapy Comparing Standard and Autoclaved Peanuts in Peanut-Allergic Individuals
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge
研究概览
简要总结
Peanut allergy can cause serious and potentially life-threatening allergic reactions. Oral immunotherapy (OIT) is an investigational treatment that involves giving small, gradually increasing amounts of peanut protein to help reduce allergic sensitivity. However, OIT may cause allergic reactions during treatment.
This Phase II clinical trial will compare two forms of peanut used for oral immunotherapy: standard blanched peanuts and autoclaved peanuts (peanuts heated under high temperature and pressure to modify their proteins). Participants aged 4 to 30 years with confirmed peanut allergy will be randomly assigned to receive one of the two treatments.
The study will evaluate safety, tolerability, adherence, and the ability to tolerate a higher amount of peanut protein after 12 months of therapy. The goal is to determine whether autoclaved peanuts provide a safer and better tolerated approach to peanut oral immunotherapy.
详细描述
Peanut allergy affects approximately 2% of the population and is a leading cause of food-induced anaphylaxis. Although oral immunotherapy (OIT) can increase reaction thresholds in peanut-allergic individuals, treatment-related adverse events remain common. Safer approaches to OIT are needed.
Autoclaving peanuts under controlled high-temperature and high-pressure conditions modifies peanut protein structure and reduces IgE binding. In a prior randomized double-blind oral food challenge study conducted by our group, participants tolerated significantly higher cumulative doses of autoclaved peanut compared with blanched peanut, with fewer and less severe reactions.
This is a Phase II randomized, double-blind, parallel-group clinical trial. Participants aged 4 to 30 years with confirmed IgE-mediated peanut allergy will be randomized in a 1:1 ratio to receive oral immunotherapy with either autoclaved peanuts or blanched peanuts.
The escalation phase will involve biweekly in-clinic dose increases until a maintenance dose of 300 mg peanut protein is reached, followed by 12 months of daily maintenance dosing. Double-blind, placebo-controlled food challenges will be performed at baseline, after escalation, and at study completion.
The primary endpoint is the proportion of participants in each group who tolerate a cumulative dose of 2043 mg peanut protein at the exit food challenge. Secondary endpoints include treatment-related adverse events, epinephrine use, time to maintenance, adherence, and immunologic changes.
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)
盲法说明
Participants will be randomized 1:1 to receive autoclaved or blanched peanuts. Randomization will be handled by a study coordinator not involved in outcome assessments. All other personnel, including clinicians, participants, and caregivers, will remain blinded.
入排标准
- 年龄范围
- 4 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peanut-allergic subjects between the ages of 4 and 30 years old who satisfy all the following criteria will be included:
- •A history suggestive of immediate IgE-mediated peanut allergy (more than 2 mild symptoms or more than 1 moderate or severe symptom within 120 minutes of ingestion or contact).
- •Confirmation of peanut allergy with at least one of the following:
- •Positive SPT to peanut (wheal equal of more than 3 mm above saline control).
- •Serum specific IgE equal or more than 0.35 kU/L to peanut or peanut components.
- •Previous positive oral food challenge to peanut (raw, roasted or blanched) according to EAACI guidelines.
- •Positive DBPCFC to blanched peanut at screening.
- •Signed informed consent (parental/legal guardian consent if under 18 years old).
排除标准
- •• Unstable asthma or uncontrolled chronic respiratory disease.
- •Active infectious or inflammatory conditions.
- •Non-IgE-mediated or non-immunological adverse reactions to peanuts.
- •Patients receiving immunosuppressor therapy.
- •Patients receiving β-blockers (including topical formulations).
- •Associated diseases contraindicating the use of epinephrine: cardiovascular disease or uncontrolled hypertension.
- •Eosinophilic gastrointestinal disorder.
- •Any other condition that, in the opinion of the investigators, poses excessive risk or interferes with protocol adherence.
研究组 & 干预措施
Standard blanched peanut
干预措施: Blanched peanut oral immunotherapy (Other)
Autoclaved peanut
干预措施: Autoclaved peanut oral immunotherapy (Other)
结局指标
主要结局
Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge
时间窗: At 12 months after initiation of maintenance phase
The primary outcome is the proportion of participants in each group who can tolerate a cumulative dose of 2043 mg of peanut protein (equivalent to 8172 mg crushed peanut or 8 peanuts) during the exit challenge at approximately 12 months
次要结局
未报告次要终点
研究者
Bruce Mazer
Pediatric Allergist and Senior Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre