About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Peanut Oral Immunotherapy (OIT)
Dietary supplementThis study uses a commercially available, standardized defatted peanut powder as its active intervention
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Safety During Treatment
Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in active vs control group
Sponsors and contacts
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