Clinical Trial

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

Study acronym: VITESSE
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2023-02-14; most recent amendment 2026-01-20.
Status change: Recruiting → Active, Not Recruiting 2024-09-19
Status change: Not Yet Recruiting → Recruiting 2023-03-14
Trial Details
NCT Number NCT05741476
Lead Sponsor DBV Technologies
Conditions Allergy, Peanut
Enrollment 600 participants
Start Date 2023-02-21
Primary Completion 2025-11-06 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-22