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Saturday, September 10, 2022

DBV Tech Kickstarts Phase 3 Study Of Modified Viaskin Patch For Peanut Allergy

 

  • DBV Technologies SA  initiated Phase 3 study, VITESSE, using the modified Viaskin Peanut Patch in peanut-allergic children ages 4 to 7 years. 
  • DBV expects to enroll 600 subjects for participation in the VITESSE study, randomized 2:1 active to placebo. The first patient screened is expected in Q4 2022, with the last patient screened by year-end 2023. 
  • The Company anticipates that the topline results will read out in Q1 2025.
  • VITESSE is a Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years. 
  • The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at month 12. 

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