Peanut Oral Immunotherapy in Children (IMPACT)

This is an interventional treatment trial for Peanut Hypersensitivity focused on measuring Allergy, Peanut, Peanut allergy, Hypersensitivity, Immunotherapy, Desensitization, Immunologic Read More

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.