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Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)
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.
This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals who are allergic to peanuts from having severe allergic reactions, when accidentally exposed to peanuts. The study also looks at the safety of the treatment and the effects it has on the immune system.
Age
4 - 25 years
Sex
ALL
Healthy Volunteers
No
Arkansas Children's Hospital
Little Rock, Arkansas, United States
National Jewish Health
Denver, Colorado, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
Start Date
September 1, 2013
Primary Completion Date
August 1, 2015
Completion Date
August 21, 2018
Last Updated
July 1, 2019
75
ACTUAL participants
Placebo Viaskin® Patch
BIOLOGICAL
Low-dose DBV712 Viaskin® Patch
BIOLOGICAL
High-dose DBV712 Viaskin® Patch
BIOLOGICAL
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Data Source & Attribution
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