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A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

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Trial Profile

A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Mar 2024

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At a glance

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

    • Most Recent Events

    • 07 Mar 2024 According to a DBV Technologies media release, company announce topline efficacy and safety data from year three of EPITOPE, corresponding to end-of-study results for participants completing three years of active treatment.
    • 07 Mar 2024 According to a DBV Technologies media release, interim safety and efficacy data from the open-label extension of EPITOPE, which demonstrate a robust continued treatment effect with Viaskin Peanut after two years of treatment, at The American College of Allergy, Asthma, and Immunology annual meeting.
    • 07 Mar 2024 According to a DBV Technologies media release, companys Phase 3 efficacy and safety study of Viaskin Peanut in peanut-allergic toddlers aged 1 through 3 years, is sufficient for the clinical portion of a BLA, and no additional efficacy studies were requested by the FDA.
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