Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy

Eligibility criteria for study enrollment: Inclusion Criteria: * Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and informed assent form (IAF) for subjects ≥7 years, or as per local or country specific guidelines or regulations. * Male or female subjects 2 to 17 years old at Visit 1. * Documented medical history or physician-confirmed diagnosis of IgE-mediated CMA with systemic symptoms related to ingestion of milk or dairy products. * Subjects currently following a strict cow's milk-free diet, with no consumption of dairy or baked milk products. * Cow's milk-specific IgE level at screening ≥10 kU/L * Positive Skin Prick Test (SPT) to cow's milk with a largest wheal diameter ≥6 mm. * Positive DBPCFC at screening with an eliciting dose ≤300 mg cow's milk proteins (approximately ≤9.4 mL of cow's milk). * Negative urine pregnancy test for female subjects of childbearing potential. Female subjects of childbearing potential must agree and commit to use effective medical methods of contraception for the entire duration of their participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age. * Ability to perform spirometry procedures in accordance with the American Thoracic Society guidelines (2005) for subjects ≥6 years old. Ability to perform peak expiratory flow (PEF) measurements for subjects ≥5 years old. Subjects \<8 years of age who have documented inability to adequately perfor…