Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy

Официальное название

Oral Immunotherapy Comparing Standard and Autoclaved Peanuts in Peanut-Allergic Individuals

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Autoclaved peanut oral immunotherapy
  Autoclaved peanut protein administered orally in gradually increasing doses during escalation phase up to 300 mg, followed by daily 300 mg maintenance dosing for 12 months.
• Другое Blanched peanut oral immunotherapy
  Standard blanched peanut protein administered orally in gradually increasing doses during escalation phase up to 300 mg, followed by daily 300 mg maintenance dosing for 12 months.

Первичные конечные точки

• Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge [Срок оценки: At 12 months after initiation of maintenance phase]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• The Centre for Innovative Medicine (CIM) at the Montreal Children's Hospital (MCH) — Montreal

Идентификаторы

NCT: NCT07439406 · 2026-12039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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