Safety Study of Viaskin Peanut to Treat Peanut Allergy

This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.

Inclusion Criteria:

* Physician-diagnosed peanut allergy;
* A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm;
* A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L;
* Subjects following a strict peanut-free diet.

Exclusion Criteria:

* Generalized dermatologic disease
* Spirometry forced expiratory volume in 1 second (FEV1) \<80% of the predicted value, or peak expiratory flow (PEF) \<80% of predicted value;
* Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy;
* Prior or concomitant history of any immunotherapy to any food allergy (for example EPIT, OIT, SLIT, or specific oral tolerance induction).