Pathway to Peanut Tolerance

NCT07592780 | Recruiting

• 1 other identifier: P3T01
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Allergy in Children; Food Allergy Peanut

Keywords

food allergy; peanut allergy; oral immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety During Treatment

  Baseline to EOT (18 months)

Study Arms (2)

Peanut Oral Immunotherapy

ACTIVE COMPARATOR

Dietary Supplement: Peanut Oral Immunotherapy (OIT)

Peanut Avoidance

NO INTERVENTION

Interventions

Peanut Oral Immunotherapy (OIT) DIETARY_SUPPLEMENT

This study uses a commercially available, standardized defatted peanut powder as its active intervention

Peanut Oral Immunotherapy

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[positive skin prick test to peanut extract as defined by wheal size at least 3mm above control OR peanut-specific IgE ≥0.35 kUA/L\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Paediatrics, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sze Yin Agnes Leung, MBChB

CONTACT

+85235052859; agnes.syl@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Agnes S.Y. Leung

Model Details: This study employs a prospective, open-label, non-randomized, two-arm parallel-group design to evaluate peanut oral immunotherapy (OIT) in a real-world Hong Kong pediatric population. Ninety participants will be allocated in a 4:1 ratio to either an 18-month pragmatic OIT protocol (n=100) or a standard care control group maintaining strict avoidance (n=25). As a pragmatic trial, it focuses on effectiveness and safety under routine clinical conditions rather than ideal settings. The open-label design reflects the interventional nature of the treatment, where blinding is not feasible. This model aims to generate crucial local evidence on protocol feasibility, tolerability, and clinical outcomes to inform future regional allergy care strategies.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

HK (1)