Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals
who are allergic to peanuts from having severe allergic reactions, when accidentally exposed
to peanuts. The study also looks at the safety of the treatment and the effects it has on the
immune system.

Inclusion Criteria:

- Physician-diagnosed peanut allergy OR convincing history of peanut allergy

- A skin prick test positive to peanut (wheal diameter ≥3mm greater than the saline
control) OR detectable peanut specific Immunoglobulin E (IgE) (ImmunoCAP >0.35 kUA/L)

- Positive reaction to a cumulative dose of ≤1044 mg peanut protein in the initial
qualifying Oral Food Challenge (OFC)

- Use of an effective method of contraception by females of childbearing potential to
prevent pregnancy and agree to continue to practice an acceptable method of
contraception for the duration of their participation in the study

- Ability to perform spirometry maneuvers in accordance with the American Thoracic
Society (ATS) guidelines (1994). Children ages 4-11 years who have documented
inability to adequately perform spirometry may be enrolled if Peak Expiratory Flow
(PEF) is >80% of predicted

- Provide signed informed consent or assent where indicated

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