drugset / Trial / NCT05741476
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DEFATTED POWDER OF ARACHIS HYPOGAEA L., SEMEN (PEANUTS) | Protein / enzyme biologic | 250 ug | Other |