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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: 13 Mar 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

    • 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.
    • 07 Mar 2024 According to a DBV Technologies media release, the Company used $79.6 million of cash in operations, primarily in Research and Development, with the initiation of the VITESSE trial, with the first patient screened in March 2023, preparation activities related to COMFORT studies, as well as an increase in regulatory and pre-commercialization activities. Cash used in operations increased by $23.9 million as of December 2023 compared to December 2022.
    • 07 Mar 2024 According to a DBV Technologies media release, company has activated more than 85 trial sites across North America, Australia and Europe.
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