CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
Placebo Viaskin® Patch +2 morebiological
Likely dose
Low-dose DBV712 Viaskin® Patch 100 microgramfrom 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/NCT01904604
NCT01904604Phase 2Completed

Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 22, 2013·Updated Jul 1, 2019

In Brief

A Phase 2 clinical trial evaluating Placebo Viaskin® Patch, Low-dose DBV712 Viaskin® Patch, and 1 other intervention for Peanut Hypersensitivity and 3 related conditions. Completed, enrolled 75 participants across 5 sites.

Detailed Summary

Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 22, 2013
Enrollment StartSep 1, 2013
Primary CompletionAug 1, 2015
Study CompletionAug 21, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.9 years ago

Interventions

Placebo Viaskin® Patchbiological

Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.

Low-dose DBV712 Viaskin® Patchbiological

100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

High-dose DBV712 Viaskin® Patchbiological

250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.