Viaskin® Peanut

Strict avoidance of peanut is essential, as even trace amounts of peanut can cause severe allergic reactions.

 

Peanut allergy is one of the most common food allergies, and can cause severe, potentially fatal, allergic reactions, including anaphylaxis.

According to recent studies, food allergies, mainly peanut, are responsible for 150 to 200 deaths every year in the United States and more than 125,000 emergency room visits.

While anaphylactic shock is the most severe allergic reaction to peanuts, many patients also suffer from a poor quality of life. Peanut allergies have lifelong effects and are often associated with psychological traumas, including fear of eating, antisocial behavior and anxiety.

Allergy to peanuts appears to be on the rise and its prevalence has increased in the past 10 years. According to an article published in The Journal of Allergy and Clinical Immunology, a recent survey in the United States indicated that approximately 1% of the U.S. population, or more than three million people, are allergic to peanuts and/or nuts. 

Two recent studies conducted in the United States and the United Kingdom show that peanut allergy has doubled in five years in children below age five

A study funded by Food Allergy Research and Education, Inc., or FARE, indicates that the number of children in the United States with peanut allergy more than tripled between 1997 and 2008. Although some patients outgrow their peanut allergies, research indicates that only about 20% of individuals with peanut allergy outgrow it during a lifetime. 

Development program for Viaskin® Peanut

Phase Ib Clinical Trial

In July 2010, DBV Technologies initiated the first clinical trial of Viaskin® Peanut in the United States

A Phase Ib trial to evaluate the safety and tolerability of repeated epicutaneous administration of Viaskin® Peanut in patients allergic to peanuts.

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Phase IIb clinical studies – VIPES

VIPES (Viaskin® Peanut’s Efficacy and Safety)

VIPES (Viaskin® Peanut’s Efficacy and Safety) was a double-blind, placebo-controlled, multi-center clinical trial conducted at 22 sites in North America and Europe that enrolled 221 patients.

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Phase II Follow-Up Study – OLFUS-VIPES

OLFUS-VIPES (Open-Label Follow-Up Study-Viaskin Peanut’s Efficacy and Safety)

OLFUS-VIPES (Open-Label Follow-Up Study-Viaskin Peanut’s Efficacy and Safety) was an open-label follow-up Phase IIb clinical trial to VIPES.

The study assessed the long-term efficacy and safety of Viaskin® Peanut in patients with peanut allergy. The study enrolled 171 patients who had previously received either placebo or one of three 12-month dose regimens administered during VIPES.

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Phase III clinical study - PEPITES

PEPITES (Peanut EPIT® Efficacy and Safety Study)

PEPITES (Peanut EPIT® Efficacy and Safety Study) was a global, pivotal, double-blinded, placebo-controlled Phase III trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 μg in children ages 4 to 11 years.

PEPITES enrolled 356 patients and was conducted in 31 centers across North America (Canada and the United States), Germany, Ireland and Australia. 

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Phase III clinical study – PEOPLE

PEOPLE (PEPITES OPen Label Extension Study)

PEOPLE (PEPITES OPen Label Extension Study) is a global, Phase III extension trial of Viaskin Peanut that enrolled 300 patients.

After patients completed the 12-month placebo-controlled period in PEPITES, they were eligible to enroll in PEOPLE to receive up to 36 months of open-label treatment with Viaskin Peanut 250 μg.

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Phase III clinical study - REALISE

REALISE (REAL LIfe Use and Safety of EPIT)

REALISE (REAL LIfe Use and Safety of EPIT®) is a multicenter, randomized, double-blind, placebo-controlled Phase III study designed to assess the use of Viaskin® Peanut 250 μg in routine medical practice and generate safety data after six months of blinded treatment.

The study enrolled 393 patients 4 to 11 years of age.

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Phase III clinical study - EPITOPE

EPITOPE (EPIT in TOddlers with PEanut Allergy)

EPITOPE (EPIT in TOddlers with PEanut Allergy) is a global, Phase III clinical trial assessing the safety and efficacy of Viaskin Peanut for the treatment of peanut-allergic patients one to three years of age.

EPITOPE is a two-part, pivotal, double-blind, placebo-controlled trial.

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Academic development program for Viaskin® Peanut

ARACHILD

ARACHILD was a multi-center double blind placebo-controlled clinical trial designed to assess the efficacy and safety of Viaskin® Peanut in peanut allergic children, ages five – 17.

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CoFAR6

Consortium for Food Allergy Research 6

In October 2013, the Consortium for Food Allergy Research, or CoFAR, launched a multi-center, randomized, double-blind, placebo-controlled trial to evaluate Viaskin® Peanut in children and adults allergic to peanuts.

This trial was sponsored and funded by The National Institute of Allergy and Infectious Diseases, or NIAID, an institute of the United States National Institutes of Health

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