Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: Viaskin Peanut 250mcg; Placebo
Intervention description: Peanut extract cutaneous patch; Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 356.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein
      to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age
      after a 12-month treatment by epicutaneous immunotherapy (EPIT).
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Male or female children aged 4 through 11 years;

          2. Physician-diagnosis of peanut allergy or children with a well documented medical
             history of IgE-mediated symptoms after ingestion of peanut and currently following a
             strict peanut-free diet, but without a physician diagnosis;

          3. Peanut-specific IgE level (ImmunoCAP system) >0.7 kU/L;

          4. Positive peanut skin prick test (SPT) with a largest wheal diameter:

               -  ≥6 mm for children 4 through 5 years of age at Visit 1,

               -  ≥8 mm for children 6 years and above at Visit 1;

          5. Positive DBPCFC at ≤300 mg peanut protein.

        Main Exclusion Criteria:

          1. History of severe anaphylaxis to peanut with any of the following symptoms:
             hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or
             incontinence);

          2. Generalized dermatologic disease

          3. Diagnosis of mast cell disorders, including mastocytosis or uricaria pigmentosa as
             well as hereditary or idiopathic angioedema;

          4. Diagnosis of asthma that fulfills any of the following criteria:

               -  Uncontrolled persistent asthma as defined by National Asthma Education and
                  Prevention Program Asthma guidelines 2007 or by Global Initiative for Asthma
                  guidelines 2015,

               -  Asthma treated with either a high daily high dose of inhaled corticosteroid or
                  with a combination therapy of a medium or high daily dose of inhaled
                  corticosteroid with a long acting inhaled β2 agonist or with a combination
                  therapy of a high daily dose of inhaled corticosteroid with a long acting inhaled
                  β2 agonist. Asthmatic subjects treated with a medium daily dose of inhaled
                  corticosteroids are eligible. Intermittent asthmatic subjects who require
                  intermittent use of inhaled corticosteroids for rescue are also eligible,

               -  Two or more systemic corticosteroid courses for asthma in the past year or 1 oral
                  corticosteroid course for asthma within 3 months prior to Visit 1, or during
                  screening period,

               -  Prior intubation/mechanical ventilation for asthma within 1 year prior to Visit
                  1, or during screening;

          5. Receiving β-blocking agents, angiotensin-converting enzyme inhibitors,
             angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant
             therapy;

          6. Received anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or
             any biologic immunomodulatory therapy within 1 year prior to Visit 1, during screening
             period or during study participation;

          7. Use of systemic long-acting corticosteroids within 12 weeks prior to Visit 1 and/or
             use of systemic short-acting corticosteroids within 4 weeks prior to Visit 1 or during
             screening;

          8. Prior or concomitant history of any immunotherapy to any food;

          9. Receiving or planning to receive any aeroallergen immunotherapy during their
             participation in the study. Aeroallergen immunotherapy must be discontinued at the
             time of Visit 1;

         10. Any disorder in which epinephrine is contraindicated such as coronary artery disease,
             uncontrolled hypertension, or serious ventricular arrhythmias.