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 range
4 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* • 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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