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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2024

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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

    • 12 Jun 2024 Planned End Date changed from 1 Mar 2025 to 1 May 2029.
    • 12 Jun 2024 Planned primary completion date changed from 1 Mar 2025 to 1 Sep 2026.
    • 07 Mar 2024 According to a DBV Technologies media release, an increase of $15.4 million in Research and Development expenses reflecting intensified Research and Development activities following the initiation of the VITESSE trial, with the first patient screened in March 2023, as well as preparations for COMFORT.
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