Peanut Oral Immunotherapy in Children

Inclusion Criteria:

* Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
* Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
* Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
* A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
* Written informed consent from parent/guardian.

Exclusion Criteria:

* History of severe anaphylaxis with hypotension to peanut;
* Documented clinical history of allergy to oat;
* Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
* Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
* Active eosinophilic gastrointestinal disease in the past 2 years;
* Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1;
* Inhalant allergen immunotherapy that has not yet reached maintenance dosing;
* Severe asthma, as indicated by repeated hospitalizations or hospital emergency department visits;
* Moderate asthma defined according to National Asthma Education and Prevention Program Expert;
* Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate control;
* Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation;
* Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1;
* Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic corticosteroid therapy of up to a total of three weeks is allowed;
* Use of any investigational drug in 90 days prior to visit -1;
* Plan to use any investigational drug during the study period;
* The presence of any medical condition that the investigator deems incompatible with participation in the trial.