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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: 02 Jul 2025

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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

  • 25 Jun 2025 According to DBV Technologies media release, data from this trial will support the submission of a BLA anticipated in 2H 2026 under the Accelerated Approval Pathway, as previously agreed to with FDA.
  • 12 Jun 2025 According to DBV Technologies media release, the company announced upcoming participation in the European Academy of Allergy and Clinical Immunology (EAACI) Congress, June 13 - 16, 2025, in Glasgow, United Kingdom. DBV will present poster and will also host a symposium and exhibit booth in the EAACI exhibit hall.
  • 08 Jan 2025 According to a DBV Technologies media release, data from the study will be presented poster presentations at the Eastern Food Allergy & Comorbidity Conference, which is being held January 9th through 12th, 2025, in Palm Beach, Florida.

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