A Phase 2 interventional study of Autoclaved peanut oral immunotherapy and Blanched peanut oral immunotherapy in Peanut Allergy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting at 1 site in Canada. Open to participants aged 4 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 2, Interventional, and Treatment
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.
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.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 57 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
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Peanut-allergic subjects between the ages of 4 and 30 years old who satisfy all the following criteria will be included:
Exclusion Criteria:
Unstable asthma or uncontrolled chronic respiratory disease.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Blanched peanut oral immunotherapy
Other: 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.
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.
Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge
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
Time frame: At 12 months after initiation of maintenance phase
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →