NCT01675882

Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy

A Double-blind, Placebo-controlled, Randomized Trial to Study the Viaskin Peanut's Efficacy and Safety for Treating Peanut Allergy in Children and Adults.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: DBV Technologies · Industry
• Sex: All
• Age: 6 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this dose-finding study for the treatment of peanut allergy are: * To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment. * To evaluate the safety of a long-term treatment with Viaskin Peanut.

Detailed description

Peanut allergy is a common allergy in the United States, with a prevalence in the general population as high as 1%. Peanut allergy management is based on strict peanut avoidance and injectable epinephrine after the allergic systemic reactions have started. Specific Immunotherapy methods currently available have shown some limitations in their use because of safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy. DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Avoiding contact between the allergen and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented The VIPES study is a 12-month double-blind, placebo-controlled,randomized trial to study the efficacy and safety of Viaskin Peanut in subjects from 6 to 55 years old with a history of immediate hypersensitive reaction to peanut protein. The trial will be conducted at sites with investigators and staff trained and experienced in the diagnosis and the management of peanut allergy and anaphylaxis, and who are capable of performing a double-blind placebo-controlled food challenge (DBPCFC) in adult and/or pediatric subjects. Three doses of peanut proteins, i.e. 50 mcg, 100 mcg and 250 mcg will be evaluated for the study. Following the confirmation of peanut allergy at screening, subjects will be randomized in a 1:1:1:1 ratio into four different treatment groups, including 50 mcg, 100 mcg and 250 mcg peanut protein or placebo. Treatment will be comprised of daily applications of Viaskin Peanut or placebo patch for 12 months. Each subject will undergo two DBPCFCs: one at screening and one at Month 12. A follow up visit will be performed 2 weeks after completion of treatment and the last DBPCFC.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Viaskin Peanut 50 mcg	Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract
BIOLOGICAL	Viaskin Peanut 100 mcg	Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract
BIOLOGICAL	Viaskin Peanut 250 mcg	Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
BIOLOGICAL	Viaskin Placebo	Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-08-30
• Last updated: 2021-10-27
• Results posted: 2021-10-27

Locations

24 sites across 5 countries: United States, Canada, France, Netherlands, Poland