Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels

Inclusion Criteria: * Age 1 to 55 years * A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat) * Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods * A weight / IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above * Positive double-blind, placebo-controlled food challenge (DBPCFC) to one of the relevant foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg) Exclusion Criteria: * Clinically significant laboratory abnormalities at screening. * Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC. * Poorly controlled or severe asthma/wheezing at screening * History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation. * Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of screening. * Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers. * Past or current history of eosinophilic gastrointestinal disease within three years of screening. * Past or current history of cancer, or currently being investigated for possible cancer. * Past or current history of any food immunotherapy (e.g., oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT) within 6 months of screening. * Treatment with monoclonal antibody therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, or other immunomodulatory therapy within 6 months of screening. * Inability to discontinue antihistamines for minimum wash-out periods required for skin prick tests (SPTs) or oral food challenges (OFCs). * Pregnant or breastfeeding, or intending to become pregnant during the study * Evidence of clinically significant chronic disease.