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

NCT07439406 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-12039
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peanut Allergy

Keywords

Autoclaved peanut; Oral immunotherapy; OIT; peanut allergy

Outcome Measures

Primary Outcomes (1)

• 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

  At 12 months after initiation of maintenance phase

Study Arms (2)

Standard blanched peanut

ACTIVE COMPARATOR

Other: Blanched peanut oral immunotherapy

Autoclaved peanut

EXPERIMENTAL

Other: Autoclaved peanut oral immunotherapy

Interventions

Autoclaved peanut oral immunotherapy OTHER

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.

Autoclaved peanut

Blanched peanut oral immunotherapy OTHER

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.

Standard blanched peanut

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

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

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Bruce Mazer, Dr.

CONTACT

514-934-1934; bruce.mazer@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized 1:1 to receive autoclaved or blanched peanuts. Randomization will be handled by a study coordinator not involved in outcome assessments. All other personnel, including clinicians, participants, and caregivers, will remain blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Allergist and Senior Scientist

Model Details: We propose a randomized, double-blind, parallel-group phase II trial comparing OIT using autoclaved versus blanched peanuts in individuals with confirmed IgE-mediated peanut allergy.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CA (1)