NCT07592780 Pathway to Peanut Tolerance

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This trial targets 125 participants in total. It began in 2025-11-15 with a primary completion date of 2028-12-30.

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.

Eligibility Criteria

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

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