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NOT YET RECRUITING
NCT07439406
PHASE2

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

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

4 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2026-08-01

Completion Date

2028-08-31

Last Updated

2026-03-03

Healthy Volunteers

No

Conditions

Interventions

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.

OTHER

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.

Locations (1)

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

Montreal, Quebec, Canada