Peanut Oral Immunotherapy Study of Early Intervention for Desensitization

Inclusion Criteria: * Aged 1 to \< 4 years at randomization. * Written informed consent from the legal guardian/parent (or both parents where required by local authorities). Provide assent where required and as appropriate per local requirements. * Sensitivity to peanut, defined as one of the following: * No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within 12 months before randomization. * Documented history of physician-diagnosed IgE-mediated peanut allergy that includes the onset of characteristic\* signs and symptoms of allergy within 2 hours of known oral exposure to peanut or peanut-containing food, and has a mean wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained within 12 months before randomization. * Development of age-appropriate dose-limiting allergy symptoms after consuming single doses of peanut protein \> 3 mg to ≤ 300 mg in a screening DBPCFC. * A palatable vehicle food to which the subject is not allergic must be available for administering study product. Exclusion Criteria: * History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC. * History of hemodynamically significant cardiovascular or renovascular disease, including uncontrolled or inadequately controlled hypertension. * History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic, recurrent, or severe gastroe…