Oral Immunotherapy for Peanut and Tree Nut Allergy

Not currently recruiting at 1 trial location

Overseen By Duncan Lejtenyi, MSc

Age: < 65

Sex: Any

Trial Phase: Academic

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

Must not be taking: Immunosuppressors, β-blockers

Disqualifiers: Respiratory instability, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether people with peanut and tree nut allergies can build tolerance through oral immunotherapy. Participants will be divided into three groups: one receiving no treatment, one receiving low doses of allergens, and another receiving higher doses. The trial aims to determine if gradually increasing these allergens can lessen allergic reactions. Individuals who have experienced immediate allergic reactions to peanuts or tree nuts, such as itching or breathing problems, might be suitable for this trial.

As an unphased trial, participants can contribute to groundbreaking research that could lead to new allergy treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressor therapy or β-blockers. If you are taking these, you would need to stop them to join the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that oral immunotherapy (OIT) for peanut and tree nut allergies has been tested in various settings. In studies with infants and toddlers, OIT proved safe, with most children handling the treatment well. Common side effects included mild reactions like itching or stomach discomfort, while serious reactions were rare.

Another study found OIT generally safe for preschool children with tree nut allergies, with most side effects being mild. These findings suggest that while mild discomfort may occur, severe reactions are uncommon.

Overall, OIT has been studied as a way to reduce allergy sensitivity, and existing research supports its safety for many patients. However, individual experiences can vary, so participants should be monitored by healthcare professionals during the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Oral immunotherapy for peanut and tree nut allergies is unique because it aims to gradually desensitize patients to allergens by exposing them to small, controlled doses of the allergen itself. Unlike current treatments, which mainly involve strict avoidance of allergens and emergency management with epinephrine, this approach could potentially reduce the severity of allergic reactions over time. Researchers are particularly excited about the potential for different dosing strategies—low-dose and high-dose regimens—to improve patients' tolerance and enhance their quality of life. This method offers a promising new avenue for managing allergies beyond traditional avoidance and emergency measures.

What evidence suggests that this trial's treatments could be effective for peanut and tree nut allergy?

Research has shown that oral immunotherapy (OIT) can help individuals with peanut and tree nut allergies become more tolerant. In this trial, participants will receive varying doses of OIT in different groups. Studies have found that children using OIT, such as the product Palforzia, can safely handle more peanuts over time. Specifically, one study found that 58% of children could consume significantly more peanut protein after treatment. Another study demonstrated that young children on OIT for peanut and tree nut allergies achieved positive results, with many tolerating more of these nuts. While OIT is not a cure, it can reduce the risk of severe allergic reactions by gradually acclimating the body to the allergen. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 2-40 with a history of immediate allergic reactions to peanuts or tree nuts, confirmed by skin tests and specific IgE blood tests. They must have had a reaction within 120 minutes of exposure and consent from parents/guardians if underage. It excludes those with unstable respiratory conditions, immune diseases, severe hypertension, on immunosuppressors or β-blockers.

Inclusion Criteria

Patients between 2 and 40 years of age who satisfy all the following criteria will be included:

A history suggestive of immediate allergy to peanut/tree nut. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact (or inhalation in the case of fish and shellfish). Reactions will be considered mild if they involve pruritus, urticaria, flushing, or rhinoconjunctivitis; moderate if they involve angioedema, throat tightness, gastrointestinal complaints, or breathing difficulties (other than wheeze); and severe if they involve wheeze, cyanosis, or circulatory collapse. The presence of at least one of the following confirmatory tests:

Positive SPT to peanut/tree nut or its proteins (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of peanut/tree nut (Omega Labs, Toronto, Ontario).

Exclusion Criteria

You have breathing problems that are not under control or stable.

You have a serious form of cancer or immune system disease.

Patients receiving immunosuppressor therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of the appropriate allergen, up to a dose of 30 mg or 300 mg, followed by a maintenance period of six months

6 months

Regular visits for dose escalation and monitoring

Follow-up

Participants undergo a single-blind, placebo-controlled oral food challenge to assess desensitization

1 month

1 visit (in-person)

Long-term Monitoring

Participants are monitored for changes in immunological markers such as IgG4, IgA, IgE, and DNA methylation levels

21 months

What Are the Treatments Tested in This Trial?

Interventions

• Oral immunotherapy

Trial Overview The study is testing oral immunotherapy's ability to induce tolerance in patients allergic to peanuts and tree nuts. Participants are randomly divided into two groups: one receiving the therapy and another serving as a control group without any intervention.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Following randomization, this arm will receive no intervention. After twelve months, participants in this group will undergo a singe-blind, placebo-controlled oral food challenge

Group II: Low-dose Active Control 1 Intervention

Following randomization, participants in this group will receive escalating doses of the appropriate allergen, up to a dose of 30 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge

Group III: High-dose Active Control 1 Intervention

Following randomization, participants in this group will receive escalating doses of the appropriate allergen, up to a dose of 300 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Julia Upton, Hospital for Sick Children, University of Toronto

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

Oral immunotherapy (OIT) has been shown to effectively increase the threshold of reactivity to peanuts and other food allergens, improving patients' quality of life, as evidenced by numerous studies and meta-analyses.

While OIT can cause common adverse events during treatment, serious reactions are rare, and most patients are willing to continue treatment due to the potential benefits of protection against accidental allergen exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral immunotherapy for peanut allergy: The pro argument. Chinthrajah, RS., Cao, S., Dunham, T., et al.[2020]

In a real-world study involving 270 preschool children undergoing peanut oral immunotherapy (P-OIT), 90% successfully reached the maintenance dose, indicating high treatment adherence and efficacy.

The majority of reactions during treatment were mild, with only 4.1% of patients requiring epinephrine, suggesting that P-OIT is generally safe, although there is a small risk of severe reactions in some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Real-World Safety Analysis of Preschool Peanut Oral Immunotherapy. Soller, L., Abrams, EM., Carr, S., et al.[2020]

Gamma irradiation of walnut, cashew, hazelnut, and almond flours significantly reduces harmful microbial contamination without affecting total protein or allergen content, making these flours suitable for oral immunotherapy (OIT) trials.

The processed tree nut flours maintain stable microbial levels, protein, and allergen content over a 24-month period, ensuring they meet FDA standards for safety and efficacy in OIT drug products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irradiated Tree Nut Flours for Use in Oral Immunotherapy. Penumarti, A., Szczepanski, N., Kesselring, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9932561/

Oral immunotherapy for food allergy Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind ...

2. aaaai.org aaaai.org/tools-for-the-public/conditions-library/allergies/the-current-state-of-oral-immunotherapy

The Current State of Oral Immunotherapy ... oral immunotherapy (OIT) product for peanut allergy, called PalforziaTM. ... nuts and bolts of these processes for clinicians and patients alike. Learn ...

3. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2300145

Oral Immunotherapy for Peanut Allergy in Children 1 to Less ... Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219824009516

Safety and Feasibility of Peanut, Tree Nut, and Sesame ... This was a retrospective study of subjects 24 months and younger initiated on OIT for peanut, tree nut, or sesame allergy within the Scripps Clinic allergy ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/all.16493

Oral Immunotherapy in Peanut‐Allergic Adults Using Real‐ ... Exposure to nuts in allergic adults may be associated with more severe reactions (odds ratio of 8.9 for reduced consciousness, 3.7 for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39357559/

Safety and Feasibility of Peanut, Tree Nut, and Sesame Oral ... Safety and Feasibility of Peanut, Tree Nut, and Sesame Oral Immunotherapy in Infants and Toddlers in a Real-World Setting. J Allergy Clin ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2731305/

Safety of a peanut oral immunotherapy protocol in ... Nutrients in 1 Ounce of Tree Nuts and Peanuts. International Tree Nut Council Nutrition Research & Education Foundation. 2006 Oct; ttp:// www.nuthealth.org/ ...

8. aacijournal.biomedcentral.com aacijournal.biomedcentral.com/articles/10.1186/s13223-024-00916-5

Safety and adherence of early oral immunotherapy for peanut ... Real-world safety analysis of preschool tree nut oral immunotherapy. J Allergy Clin Immunol Pract. 2023;11(4):1177–83. Article CAS PubMed ...