Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Peanut allergy is a common allergy in the United States, with a prevalence in the general
      population as high as 1%. 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 VIPES study is a 12-month double-blind, placebo-controlled,randomized trial to study the
      efficacy and safety of Viaskin Peanut in subjects from 6 to 55 years old with a history of
      immediate hypersensitive reaction to peanut protein.

      The trial will be conducted at sites with investigators and staff trained and experienced in
      the diagnosis and the management of peanut allergy and anaphylaxis, and who are capable of
      performing a double-blind placebo-controlled food challenge (DBPCFC) in adult and/or
      pediatric subjects. Three doses of peanut proteins, i.e. 50 mcg, 100 mcg and 250 mcg will be
      evaluated for the study. Following the confirmation of peanut allergy at screening, subjects
      will be randomized in a 1:1:1:1 ratio into four different treatment groups, including 50 mcg,
      100 mcg and 250 mcg peanut protein or placebo. Treatment will be comprised of daily
      applications of Viaskin Peanut or placebo patch for 12 months. Each subject will undergo two
      DBPCFCs: one at screening and one at Month 12. A follow up visit will be performed 2 weeks
      after completion of treatment and the last DBPCFC.
    

Intervention name(s): Viaskin Peanut 50 mcg; Viaskin Peanut 100 mcg; Viaskin Peanut 250 mcg; Viaskin Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 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
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)