CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 414 enrolled
Drug / intervention
Part A Viaskin Peanut 250 mcg +4 morebiological
Likely dose
Part A Viaskin Peanut 250 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03211247
NCT03211247Phase 3Completed
CompareCT.gov

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.

DBV Technologies·interventional·Posted Jul 7, 2017·Updated Dec 16, 2024

In Brief

A Phase 3 clinical trial evaluating Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg, and 3 other interventions for Peanut Allergy. Completed, enrolled 414 participants across 51 sites in 8 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesAustralia, Canada, France, Germany, Ireland, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 7, 2017
Enrollment StartJul 31, 2017
Primary CompletionAug 20, 2019
Study CompletionApr 27, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.0 years ago

Interventions

Part A Viaskin Peanut 250 mcgbiological

Viaskin Peanut 250 mcg, once daily

Part A Viaskin Peanut 100 mcgbiological

Viaskin Peanut 100 mcg, once daily

Part A Placebobiological

Placebo patch, once daily

Part B Viaskin Peanut 250 mcgbiological

Viaskin Peanut 250 mcg, once daily

Part B Placebobiological

Placebo patch, once daily