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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy Comparing Standard and Autoclaved Peanuts in Peanut-Allergic Individuals
- ClinicalTrials.gov ID
- NCT07439406
- Acronym / sponsor ID
- 2026-12039
- Conditions
- Peanut Allergy
- Keywords
- Autoclaved peanut, Oral immunotherapy, OIT, peanut allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard blanched peanut | Active comparator | Other: Blanched peanut oral immunotherapy |
| Autoclaved peanut | Experimental | Other: Autoclaved peanut oral immunotherapy |
Who may qualify
- Ages
- 4 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Peanut-allergic subjects between the ages of 4 and 30 years old who satisfy all the following criteria will be included:
Key exclusion criteria (8 listed)
- • Unstable asthma or uncontrolled chronic respiratory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autoclaved peanut oral immunotherapyAutoclaved 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 | Autoclaved peanut |
| Blanched peanut oral immunotherapyStandard 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. | Other | Standard blanched peanut |
Primary outcome
Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge
Time frame: At 12 months after initiation of maintenance phase
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce Mazer, Dr. (514-934-1934 ext. 76375, bruce.mazer@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge (time frame: At 12 months after initiation of maintenance phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.