At a glance
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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)
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
Timeline
Interventions
Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.
100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.