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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: 24 Jul 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

  • 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.
  • 30 Jun 2026 According to a DBV Technologies media release, the company collaborated with FDA through meetings, information exchanges, and filings for the VIASKIN Peanut Patch Investigational New Drug Application (IND). Through this process and based on its review. The FDA has not requested additional data. The company will take time required to incorporate that feedback and now anticipates filing of the BLA to occur in the third quarter of 2026.

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