Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: Viaskin Peanut 50 mcg; Viaskin Peanut 100 mcg; Viaskin Peanut 250 mcg; Viaskin Placebo
Intervention description: Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract; Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract; Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract; Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 6 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Food allergy; Immediate hypersensitivity; Whole peanut extract; Allergenic product; Specific Immunotherapy; Epicutaneous Immunotherapy (EPIT)

Summary:

      The objectives of this dose-finding study for the treatment of peanut allergy are:

        -  To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg
           peanut protein per patch) to significantly desensitize peanut-allergic subjects to
           peanut after 12 months of treatment.

        -  To evaluate the safety of a long-term treatment with Viaskin Peanut.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peanut-allergic subjects between 6 and 55 years of age, with a well-documented medical
             history of systemic reactions after ingestion of peanut and currently following a
             strict peanut-free diet.

          -  Peanut-specific immunoglobulin E (IgE) level (Phadia CAP-system) > 0.7 kU/L and a
             positive skin prick test to peanut with a largest wheal diameter ≥ 8 mm

          -  Positive double-blind placebo-controlled food challenge (DBPCFC) at ≤ 300 mg of peanut
             proteins: the eliciting dose of peanut proteins during the DBPCFC is capped at 300 mg,
             i.e. subjects must react to peanut before reaching or at the dose of 300 mg peanut
             proteins.

          -  Negative pregnancy test for women of childbearing potential. Females of childbearing
             age must use effective methods of contraception to prevent pregnancy and agree to
             continue to practice an acceptable method of contraception for the duration of
             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 maneuvers in accordance with the American Thoracic
             Society guidelines (2005) for subjects 9 years of age and above Subjects below 9 years
             of age can perform peak expiratory flow (PEF) instead.

          -  Willing to comply with all study requirements during their participation in the study.

          -  Provide signed informed consent and assent as appropriate.

        Exclusion Criteria:

          -  Subjects with a history of severe anaphylaxis to peanut with the following symptoms:
             hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or
             incontinence).

          -  Pregnancy or lactation.

          -  FEV1 <80% of the predicted value at screening for subjects 9 years of age and above.
             PEF < 80% of predicted for subjects below 9 years of age.

          -  Subjects who did not react at or below the dose of 300 mg of peanut proteins during
             the DBPCFC at screening.

          -  Known allergy or known hypersensitivity to placebo excipients either of the Viaskin
             patches or of the food challenge formulas.

          -  Subjects reacting objectively to the placebo formula at screening.

          -  Severe reaction during the screening food challenge, defined as need for intubation,
             hypotension persisting after epinephrine administration, or the need for more than two
             doses of epinephrine.

          -  Inability to discontinue short-acting antihistamines for three days or long-acting
             antihistamines for five to seven days (depending on half-life) prior to skin prick
             testing or food challenges.

          -  Subjects treated with systemic long-acting corticosteroids (depot corticosteroids)
             within 12 weeks prior to the screening visit and/or systemic short-acting
             corticosteroid within 4 weeks prior to the screening visit or any systemic
             corticosteroid at screening.

          -  Subjects with asthma defined as follows:

               1. uncontrolled persistent asthma by National Asthma Education and Prevention
                  Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or
                  being treated with combination therapy of medium dose inhaled corticosteroid with
                  a long acting inhaled β2-agonists;

               2. at least two systemic corticosteroid courses for asthma in the past year or one
                  oral corticosteroid course for asthma in the past three months;

               3. prior intubation for asthma in the past two years.

          -  Subjects on β-blocking agents, angiotensin-converting enzyme inhibitors,
             angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant
             therapy.

          -  Subjects undergoing any type of immunotherapy to any food within one year prior to the
             screening visit.

          -  Subjects presently on aeroallergen immunotherapy and unwilling or unable to
             discontinue.

          -  Subjects currently treated with anti-tumor necrosis factor drugs or anti-IgE drugs
             (such as omalizumab) or any biologic immunomodulatory therapy within one year prior to
             the screening visit.

          -  Allergy or known history of reaction to Tegaderm®.

          -  Subjects suffering from generalized dermatologic diseases (e.g. severe atopic
             dermatitis, uncontrolled generalized eczema, keratosis pilaris, ichthyosis vulgaris)
             with no intact skin zones to apply the patches.

          -  Any disorder in which epinephrine is contraindicated such as coronary artery disease,
             uncontrolled hypertension, or serious ventricular arrhythmias.

          -  Participation in another clinical intervention study in the three months prior to the
             screening visit.

          -  Subjects on any experimental drugs or treatments.

        Other inclusion/exclusion criteria may apply.