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A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children

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Trial Profile

A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Mar 2023

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At a glance

  • Drugs Peanut allergy immunotherapy (Primary) ; Histamine dihydrochloride
  • Indications Peanut hypersensitivity
  • Focus Registrational; Therapeutic Use
  • Acronyms PEPITES
  • Sponsors DBV Technologies

    • Most Recent Events

    • 14 Mar 2023 Results by deriving : Serum-specific IgG4 and IgE (whole peanut and components) from subjects enrolled in the phase 3 PEPITES, assessing immune response in Peanut Epicutaneous Immunotherapy for Peanut-Allergic Children, published in the Allergy
    • 25 Apr 2022 Results of an analysis assessed the to assess psychometric parameters of the Food Allergy Quality of Life Questionnaire-Parent Form (FAQLQ-PF) published in the Allergy
    • 22 Feb 2022 According to a DBV Technologies media release, pooled safety data from Phase 3 studies of epicutaneous immunotherapy with investigational Viaskin Peanut 250 µg in children aged 4 to 11 years, following treatment for up to 36 months in peanut-allergic children will be presented at the upcoming participation at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Scientific meeting ,2022.
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