Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Condition: Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity; Hypersensitivity, Immediate
MeSH terms: Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Peanut Hypersensitivity
Intervention: Placebo Viaskin® Patch; Low-dose DBV712 Viaskin® Patch; High-dose DBV712 Viaskin® Patch
Intervention description: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.; 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.; 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 4 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Peanut Allergy; Food Allergy; Viaskin peanut patch; Allergen Immunotherapy; Epicutaneous Immunotherapy; Whole peanut extract; Allergenic product; Immediate hypersensitivity

Summary:

      Food allergy occurs when the immune system reacts against foods. The immune system is the
      part of the body that protects us from illness and germs, but it can also cause allergies.
      Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries.
      There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be
      severe and life threatening. The only way that you can prevent an allergic reaction is to
      avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and
      people can be accidently exposed to peanut proteins. Treatment for accidental exposure
      include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin)
      which must be carried at all times. DBV Technologies has developed an epicutaneous delivery
      system, a patch that puts the peanut protein on the skin.
    

Eligibility criteria:

        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