Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

Exclusion Criteria

• •History of anaphylaxis to peanut resulting in hypotension, neurological compromise or requiring mechanical ventilation
• •Participation in a study using an investigational new drug in the last 30 days
• •Participation in any interventional study for the treatment of food allergy in the past 6 months
• •Pregnancy or lactation
• •Current or known allergy to the Viaskin Peanut/Placebo patch device or excipients
• •Current or known allergy to the placebo allergen (oat flour) in oral food challenge (OFC)
• •Currently in a build-up phase of any allergen immunotherapy
• •Severe or poorly controlled atopic dermatitis or greater than a mild flare of active disease at enrollment
• •Forced Expiratory Volume in 1 Second (FEV1) value \<80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (\>500mcg of Fluticasone or equivalent)
• •Use of steroid medications in the following manners: history of daily oral steroid dosing for \>1 month during the past year, or burst or steroid course in the past 3 months, or \>1 burst oral steroid course in the past year or use of oral or parenteral steroids for a non-asthma indication within the past 30 days
• •Asthma requiring \>1 hospitalization in the past year for asthma or \>1 Emergency Department (ED) visit in the past 6 months for asthma
• •Any previous intubation/mechanical ventilation due to allergies or asthma
• •Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulatory or biologic therapy in the past year
• •Use of beta-adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers in the past 30 days
• •Inability to discontinue antihistamines for skin testing and OFC
• •History of alcohol or drug abuse
• •History of cardiovascular disease, uncontrolled hypertension, arrhythmias, chronic lung disease, active eosinophilic gastrointestinal disease, or other medical conditions including immunologic disorders or HIV infection which, in the opinion of the investigator, make the subject unsuitable for treatment or at increased risk of anaphylaxis or poor outcome