Clinical Trial Finder

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.

An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:

• - Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given.

• - Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation.

• - Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks.

At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein).

• - Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks.

At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).