NCT01197053

Epicutaneous Immunotherapy in Peanut Allergy in Children

ARACHILD: A Multicentric, Double Blind Placebo-controlled Pilot Protocol to Study the Efficacy and Safety of an Epicutaneous Immunotherapy in Children Allergic to Peanut

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.

Detailed description

Peanut allergy is a common allergy in the United Sates, with prevalence in the general population as high as 1%. Peanut allergy starts in childhood, its prevalence in children has doubled in the past 5 years, and barely 20% of the allergic children will outgrow this allergy So far, the only treatments available for peanut allergy are avoidance of peanut and injectable epinephrine after the allergic systemic reactions have started. Immunotherapy methods currently available have shown some limitations in their use because of important safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy. DBV Technologies, is a French biotech company which has developed an Epicutaneous Delivery System, called Viaskin®, a method based on delivering precise quantity of allergens on the upper layers of the skin, i.e. on the epidermis and without any passage in the vascularised dermis. Avoiding contact between the allergens and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a high level of safety as systemic reactions are circumvented. The goal of this pilot study is to demonstrate that epicutaneous immunotherapy (EPIT) with Viaskin® is safe and efficacious for the desensitization of peanut-allergic children, i.e. increasing the quantity of peanut proteins they can consume symptom-free. Fifty-two (52) children from 5 to 17 years of age with a confirmed peanut allergy during a baseline double blind placebo-controlled food challenge (DBPCFC) (reacting to a capped value below 250 mg of peanut proteins) will be randomized 1 to 1 and treated either with DBV712, the Viaskin® disk loaded with 100 mcg peanut proteins (active treatment), or with placebo, the Viaskin® disk loaded with a placebo formulation devoid of peanut. Each child will receive one application of one Viaskin® on the skin every day repeatedly for 6 months in a blinded manner, followed by a 12-month open treatment with DBV712 for all of them; placebo children will all cross-over after the first 6 months of treatment to also receive the active treatment. A DBPCFC to peanut will then be conducted after every 6 months of treatment to assess the efficacy of the treatment. Safety will be assessed during the whole study period. Skin testing, peanut-specific IgE and IgG4 will occur at selected visits

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Epicutaneous Immunotherapy	100 mcg peanut proteins (active arm) applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm
BIOLOGICAL	placebo of peanut	placebo applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm

Timeline

• Start date: 2010-08-01
• Primary completion: 2015-02-01
• Completion: 2015-04-01
• First posted: 2010-09-09
• Last updated: 2015-10-20

Locations

1 site across 1 country: France