NCT03211247

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: DBV Technologies · Industry
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Not accepted

Summary

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Detailed description

The study comprised of two parts: * In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B * In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Part A Viaskin Peanut 250 mcg	Viaskin Peanut 250 mcg, once daily
BIOLOGICAL	Part A Viaskin Peanut 100 mcg	Viaskin Peanut 100 mcg, once daily
BIOLOGICAL	Part A Placebo	Placebo patch, once daily
BIOLOGICAL	Part B Viaskin Peanut 250 mcg	Viaskin Peanut 250 mcg, once daily
BIOLOGICAL	Part B Placebo	Placebo patch, once daily

Timeline

• Start date: 2017-07-31
• Primary completion: 2019-08-20
• Completion: 2022-04-27
• First posted: 2017-07-07
• Last updated: 2024-12-16
• Results posted: 2024-12-16

Locations

51 sites across 8 countries: United States, Australia, Canada, France, Germany, Ireland, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study