Peanut Oral Immunotherapy in Children

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.