MedTrace Logo

Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

NCT01904604 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-07-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Peanut Hypersensitivity
  • Food Hypersensitivity
  • Hypersensitivity
  • Hypersensitivity, Immediate

Interventions

BIOLOGICAL

Placebo Viaskin® Patch

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

BIOLOGICAL

Low-dose DBV712 Viaskin® Patch

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

BIOLOGICAL

High-dose DBV712 Viaskin® Patch

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

Sponsors & Collaborators

  • Consortium of Food Allergy Research

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Stacie M. Jones, MD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-08-31
Completion
2018-08-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01904604 on ClinicalTrials.gov