Peanut AllergyPhase 2NCT07439406
Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy
A Phase 2 study testing Autoclaved peanut oral immunotherapy and Blanched peanut oral immunotherapy in people with Peanut Allergy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 30 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Autoclaved peanut oral immunotherapy and Blanched peanut oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to 31 Aug 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Centre for Innovative Medicine (CIM) at the Montreal Children's Hospital (MCH)
Montreal, Quebec, H4A 3J1
Bruce Mazer, Dr, 514-934-1934 ext. 76375, bruce.mazer@mcgill.ca
About this study
Official title: Oral Immunotherapy Comparing Standard and Autoclaved Peanuts in Peanut-Allergic Individuals
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.
Read the detailed description
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.
- Conditions
- Peanut Allergy
- Being tested
- Autoclaved peanut oral immunotherapy, Blanched peanut oral immunotherapy
- Keywords
- Autoclaved peanut, Oral immunotherapy, OIT, peanut allergy
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autoclaved peanut oral immunotherapyOther
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.
Blanched peanut oral immunotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard blanched peanut | Active comparator | Not described Receives: Other: Blanched peanut oral immunotherapy |
| Autoclaved peanut | Experimental | Not described Receives: Other: Autoclaved peanut oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 12 months after initiation of maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Mazer, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439406
- Sponsor's protocol ID
- 2026-12039
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No