Pathway to Peanut Tolerance

A Pragmatic, Open-label Study of Peanut Oral Immunotherapy in Inducing Desensitisation or Remission in Children With Food Allergy Compared to Standard Care (Strict Allergen Avoidance)

While rigorous clinical trials have established peanut OIT as a promising therapy capable of inducing desensitization and even remission, its transition to routine clinical practice requires robust real-world evidence. Current management relies on strict avoidance, and the lack of reliable biomarkers to predict long-term success remains a significant barrier to the wider, more accessible application of OIT. Therefore, there is a critical need to evaluate peanut OIT in pragmatic, real-world settings. Such studies are essential to understand its effectiveness and safety beyond controlled trial conditions, to identify which patients benefit most, and to develop practical monitoring strategies. Generating this evidence is a crucial step toward making this treatment a viable and optimized option for the growing global population affected by peanut allergy.

Study Overview

• Status: Recruiting
• Conditions: Food Allergy in Children; Food Allergy Peanut
• Intervention / Treatment: Dietary supplement: Peanut Oral Immunotherapy (OIT)

Detailed Description

This is an open-label, non-randomized, two-arm trial designed to evaluate the real-world efficacy, safety, and tolerability of a pragmatic peanut oral immunotherapy (OIT) protocol for children under 18 in Hong Kong. The study addresses a significant unmet need by providing access to a treatment available overseas and aims to establish a translatable model for future food allergy treatments in the region. The intervention arm (n=100) will undergo 18 months of peanut OIT, while the control arm (n=25) will follow standard care, i.e., strict peanut avoidance for the same duration.

Eligible children aged 2-17 with a confirmed peanut allergy will be recruited from the Specialist Outpatient Clinic at the Prince of Wales Hospital and through referral from other public hospitals. Participants will be allocated to the active or control arm in a 4:1 ratio.

The primary efficacy measure is the proportion of participants in the OIT group versus the control group who achieve a desensitization level of more than 640 mg of peanut protein, as confirmed by an oral food challenge at the end of the 18-month treatment period.

Some of the key secondary objectives include to systematically document the frequency and severity of treatment-related adverse events and the proportion of participants discontinuing OIT due to these events; and to identify distinct pre- and post-treatment plasma protein biomarkers associated with successful OIT.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sze Yin Agnes Leung, MBChB; Phone Number: +85235052859; Email: agnes.syl@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Paediatrics, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject's parent and/ or guardian must be able to understand and provide informed consent.
• Age 2 to 17 years of age
• Either sex
• Any race, any ethnicity
• Have a history of sensitization [positive skin prick test to peanut extract as defined by wheal size at least 3mm above control OR peanut-specific IgE ≥0.35 kUA/L]

Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrolment:

• Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders)
• History of chronic diseases requiring therapy (other than asthma, atopic dermatitis, allergic rhinitis)
• Past or current major illness that in the opinion of the Site investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant
• Concurrent treatment with any allergen immunotherapy
• Participation in any trials of therapeutic interventions for FA, or therapy with anti-IgE or other biologics within 1 year of enrolment
• Current uncontrolled or moderate to severe asthma as defined by FEV1 value <80% predicted for participants aged 7 years or older and are able to perform spirometry
• Gastrointestinal eosinophilic disorders
• Use of short-acting antihistamine (e.g. chlorpheniramine) within 3 days prior to open-labelled food challenge or skin testing, or medium-acting antihistamine (e.g. cetirizine, loratadine) within 5 days prior to open-labelled food challenge or skin testing
• Use of beta-blockers, ACE inhibitors, angiotensin-receptor blockers or calcium channel blockers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peanut Oral Immunotherapy	Dietary supplement: Peanut Oral Immunotherapy (OIT); This study uses a commercially available, standardized defatted peanut powder as its active intervention
No Intervention: Peanut Avoidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desensitization Rate at EOT	Proportion of participants with a peanut eliciting dose >640 mg protein at end-of-treatment (EOT) in OIT vs control groups.	EOT (18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety During Treatment	Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in active vs control group	Baseline to EOT (18 months)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: food allergy; peanut allergy; oral immunotherapy
• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: P3T01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The potential sharing of IPD is currently under careful consideration by the institutional review board and research ethics committee. A final decision will depend on several factors, including: 1) compliance with local data protection regulations and institutional policies in Hong Kong, 2) ensuring adequate de-identification of participant data given the relatively small and potentially identifiable patient population, and 3) alignment with the specific consent obtained from participants regarding data sharing. We are committed to responsible data stewardship while maximizing the scientific value of this research, and will make a definitive determination before study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No