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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 ??g 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 ??g in 4-7-year-old Children With Peanut Allergy (VITESSE)

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

Latest Information Update: 12 Oct 2026

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At a glance

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

Most Recent Events

  • 30 Sep 2026 According to a DBV Technologies media release, company announced that the it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the VIASKIN Peanut Patch in children with peanut allergy aged 4 through 7 years supported by the results from the successful Phase 3 VITESSE trial.
  • 16 Jul 2026 According to a DBV Technologies media release, company will host a conference call today, July 16, at 5:00pm ET, to discuss scientific engagement of Peanut-allergy-immunotherapy and other updates.
  • 16 Jul 2026 According to a DBV Technologies media release, continued productive engagement with the FDA in support of the BLA in children aged 4 through 7 years.

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