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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