Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Intervention: Viaskin Peanut 250 mcg
Intervention description: Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 7 Years
Maximum age: 56 Years
Healthy volunteers: No
Keywords: Food allergy; Immediate hypersensitivity; Whole peanut extract; Allergenic product; Specific Immunotherapy; Epicutaneous Immunotherapy (EPIT)

Summary:

      The objectives of this open-label follow-up study for subjects who previously were randomized
      and have completed the VIPES study for the treatment of peanut allergy, are:

        -  To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.

        -  To evaluate the safety of long-term treatment with Viaskin Peanut.

        -  To evaluate sustained unresponsiveness to peanut after a period of 2 months without
           treatment in subjects showing desensitization to peanut after treatment with Viaskin
           Peanut.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult and pediatric subjects (≥7 years) who completed the VIPES study, with a
             mandatory and documented DBPCFC at Month 12 in the VIPES study.

          -  Signed informed consent from adult subjects or parent(s)/guardian(s) of children <18
             years and children's assent for children >7 years or as per country-specific
             regulations or laws. This consent should be signed no later than Visit 11 in the VIPES
             study.

          -  Negative pregnancy test for women of childbearing potential at Visit 10 in the VIPES
             study.

          -  Female subject of childbearing potential 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. Documented sexual
             abstinence will be accepted as an effective method of contraception for girls below 15
             years of age.

          -  Subjects and/or parents/guardians willing to comply with all study requirements during
             their participation in the study.

        Exclusion Criteria:

          -  Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for
             intubation, hypotension persisting after epinephrine administration, and/or the need
             for more than two doses of epinephrine.

          -  Pregnancy or lactation.

          -  Females of childbearing potential planning a pregnancy in the coming 2 to 3 years.

          -  Subjects who became allergic to chocolate or who do not want to consume the chocolate
             study challenge vehicle anymore.

          -  Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the
             food challenge formula used during the VIPES study.

          -  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 with asthma that has evolved and now fulfills any of the criteria defined as
             follows:

               -  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.

               -  at least two systemic corticosteroid courses for asthma in the past year or one
                  oral corticosteroid course for asthma in the past three months.

               -  prior intubation for asthma in the past year.

          -  Subjects receiving β-blocking agents, angiotensin-converting enzyme inhibitors,
             angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant
             therapy.

          -  Subjects receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE
             drugs (such as omalizumab) or any biologic immunomodulatory therapy.

          -  Subjects receiving or planning to receive any type of immunotherapy to any food (e.g.
             oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction)
             during their participation in the study.

          -  Subjects receiving or planning to receive any aeroallergen immunotherapy during their
             participation in the study.

          -  Allergy or known history of reaction to Tegaderm® with no possibilities to use an
             alternative dressing approved by the sponsor.

          -  Subjects suffering from generalized dermatologic disease (e.g. severe atopic
             dermatitis, uncontrolled generalized eczema, ichthyosis vulgaris) with no intact zones
             to apply the patches.

          -  Any new disorder in which epinephrine is contraindicated such as coronary artery
             disease, uncontrolled hypertension, or serious ventricular arrhythmias.

          -  A history of non compliance in the VIPES study. Non compliance is defined as subjects
             not applying the patch at all for 60 days or more (this can be either consecutive or
             intermittent non-application of the patches) during the whole VIPES study duration

          -  Participation in another clinical intervention study in the past year, other than the
             VIPES study.

          -  Subjects on any experimental drugs in the past year, other than those used in the
             VIPES study.

        Other inclusion/exclusion criteria may apply.