drugset / Trial / NCT05741476

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

NCT05741476 ↗

Phase 3 Active not recruiting 600 enrolled DBV Technologies
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-02-21
Primary completion
2025-11-06
Completion
2029-10

Outcome

Met primary endpoint

release “VIASKIN Peanut demonstrated a statistically significant treatment effect (p<0.001)*, with 46.6% of children in the VIASKIN Peanut arm meeting the treatment responder criteria” dbv-technologies.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject DEFATTED POWDER OF ARACHIS HYPOGAEA L., SEMEN (PEANUTS) Protein / enzyme biologic 250 ug Other

Indications