Epicutaneous Immunotherapy in Peanut Allergy in Children
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and
      efficacious for desensitizing children with peanut allergy.
    

Detailed description: 
      Peanut allergy is a common allergy in the United Sates, with prevalence in the general
      population as high as 1%. Peanut allergy starts in childhood, its prevalence in children has
      doubled in the past 5 years, and barely 20% of the allergic children will outgrow this
      allergy So far, the only treatments available for peanut allergy are avoidance of peanut and
      injectable epinephrine after the allergic systemic reactions have started. Immunotherapy
      methods currently available have shown some limitations in their use because of important
      safety issues. Hence, there is an important unmet medical need for efficient and safe
      treatment of peanut allergy.

      DBV Technologies, is a French biotech company which has developed an Epicutaneous Delivery
      System, called Viaskin®, a method based on delivering precise quantity of allergens on the
      upper layers of the skin, i.e. on the epidermis and without any passage in the vascularised
      dermis. Avoiding contact between the allergens and the bloodstream should confer to
      epicutaneous immunotherapy (EPIT) a high level of safety as systemic reactions are
      circumvented.

      The goal of this pilot study is to demonstrate that epicutaneous immunotherapy (EPIT) with
      Viaskin® is safe and efficacious for the desensitization of peanut-allergic children, i.e.
      increasing the quantity of peanut proteins they can consume symptom-free.

      Fifty-two (52) children from 5 to 17 years of age with a confirmed peanut allergy during a
      baseline double blind placebo-controlled food challenge (DBPCFC) (reacting to a capped value
      below 250 mg of peanut proteins) will be randomized 1 to 1 and treated either with DBV712,
      the Viaskin® disk loaded with 100 mcg peanut proteins (active treatment), or with placebo,
      the Viaskin® disk loaded with a placebo formulation devoid of peanut. Each child will receive
      one application of one Viaskin® on the skin every day repeatedly for 6 months in a blinded
      manner, followed by a 12-month open treatment with DBV712 for all of them; placebo children
      will all cross-over after the first 6 months of treatment to also receive the active
      treatment.

      A DBPCFC to peanut will then be conducted after every 6 months of treatment to assess the
      efficacy of the treatment. Safety will be assessed during the whole study period.

      Skin testing, peanut-specific IgE and IgG4 will occur at selected visits
    

Intervention name(s): Epicutaneous Immunotherapy; placebo of peanut
Intervention type(s): Biological; Biological
Intervention description(s): 100 mcg peanut proteins (active arm) applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm; placebo applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Peanut Allergy; Food Allergy; Epicutaneous Immunotherapy (EPIT); Food Challenge