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A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)

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Trial Profile

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Apr 2025

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At a glance

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

Most Recent Events

  • 28 Mar 2025 According to a DBV Technologies media release, company announced financing of up to 306.9 Million (284.5 Million) to Advance Viaskin Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch
  • 24 Mar 2025 According to a DBV Technologies media release,the company secured agreement with the U.S. Food and Drug Administration (FDA) on safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 to7 year olds will be sufficient to support a Biologics License Application (BLA) filing in this age group, and the COMFORT Children supplemental safety study will no longer be required.The BLA expected to be submitted 1H 2026.
  • 23 Sep 2024 According to a DBV Technologies media release, Topline results of VITESSE data are expected by Q4 2025. In Q3 2024, DBV exceeded its recruitment goal and successfully closed the screening process for the VITESSE Phase 3 study evaluating the Viaskin Peanut Patch in peanut allergic children ages 4 -7 years old

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