Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated
      epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device)
      in peanut allergic subjects.
    

Detailed description: 
      Peanut allergy is a common allergy in the United States, with a prevalence in the general
      population as high as 1%. So far, there is no approved treatment of peanut allergy. Peanut
      allergy management is based on strict peanut avoidance and injectable epinephrine after the
      allergic systemic reactions have started. Specific Immunotherapy methods currently available
      have shown some limitations in their use because of safety issues. Hence, there is an
      important unmet medical need for efficient and safe treatment of peanut allergy.

      DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method
      based on delivering precise quantity of the allergen on the upper layers of the skin.
      Avoiding contact between the allergen and the bloodstream should confer to epicutaneous
      immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented.

      The aim of this phase 1b study is to evaluate the safety and tolerability of the epicutaneous
      immunotherapy method in subjects allergic to peanut. The trial will randomize 110
      participants. Four doses of peanut proteins, 20 mcg, 100 mcg, 250 mcg and 500 mcg will be
      repeatedly delivered on the skin by dose escalation in consecutive cohorts of 5 subjects,
      starting with the lowest dose. In each cohort of 5, 4 subjects will receive peanut proteins
      and one will receive placebo in a blinded manner. For each dose, the peanut proteins will be
      applied on the skin either every day or every other day. The total duration of the treatment
      for each subject is 2 weeks. Firstly, adult subjects (18 to 50 years) with a history of
      non-severe anaphylaxis to peanut (Grade ≤3) will enroll and safety information be reviewed.
      If there are no major concerns, adolescent cohorts (12 to 17 years) with history of
      non-severe anaphylaxis to peanut will then enroll and safety again be reviewed. If there are
      no concerns, then child cohorts (6 to 11 years) with history of non-severe anaphylaxis to
      peanut will finally enroll.

      Also, after the safety review of the treated adult non-severe cohorts is satisfactorily
      performed, adult subjects with a history of severe anaphylaxis to peanut (Grades 4 or 5) will
      enroll and dose escalation will undergo.

      For the safety review, all the following parameters will be checked at each patient visit:
      physical examination, vital signs, skin examination, lab values, PEF values. FEV1, skin prick
      test to peanut and peanut-specific IgE values will also be determined at screening and end of
      treatment visits.
    

Intervention name(s): Whole peanut extract; Placebo formulation
Intervention type(s): Biological; Biological
Intervention description(s): Four different doses of whole peanut extract expressed as micrograms (mcg) of peanut proteins (20, 100, 250, 500 mcg) and two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested for determination of the maximum tolerated dose during a 2-week treatment period.; Matching placebo at two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested in parallel to the peanut proteins doses for determination of the maximum tolerated dose during a 2-week treatment period.
Other intervention name(s): DBV712 Viaskin; Placebo Viaskin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Food allergy; Immediate hypersensitivity; Whole peanut extract; Allergenic product; Specific Immunotherapy; Epicutaneous Immunotherapy (EPIT); Safety