Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy

Key Inclusion Criteria: * Age 4 to 26 years, inclusive * Written informed consent from subjects, as appropriate per local requirements, and parent/guardian * Written assent from subjects who are minors, as appropriate per local requirements * History of physician-diagnosed hen egg allergy * Elevated egg specific IgE and/or mean wheal diameter on SPT to egg * Experience dose-limiting symptoms at or before the 300 mg challenge dose of dried egg white protein on Screening DBPCFC * Use of effective birth control by sexually active female subjects of childbearing potential Key Exclusion Criteria: * History of severe or life-threatening anaphylaxis within 60 days before screening * History of non-IgE mediated hen egg allergy such as food protein-induced enterocolitis syndrome (FPIES) * History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of unknown etiology * History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema * History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) which may require a change in immunosuppressive medication regimen or chronic corticosteroid use * History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * Developing dose-limiting symptoms to placebo challenge during the Screening DBPCFC * Having the same place of residence as another subject in the study * Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety