Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy (NCT07439406) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy
Canada57 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range4 Years ā 30 Years
SexALL
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Inclusion Criteria:
* 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).
Exclusion Criteria:
* ā¢ 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 Ī²-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.
What they're measuring
1
Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge
Timeframe: At 12 months after initiation of maintenance phase
Trial details
NCT IDNCT07439406
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre