NCT02223182

Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy

A Double-Blind, Placebo-Controlled Randomized Trial to Study the Viaskin Milk Efficacy and Safety for Treating IgE-Mediated Cow's Milk Allergy in Children

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: DBV Technologies · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.

Detailed description

This is a multi-center, double-blind, placebo-controlled, randomized trial to study the safety and efficacy of Viaskin Milk applied epicutaneously every day to subjects from 2 to 17 years of age with IgE-mediated cow's milk allergy (CMA). Subjects will receive blinded treatment for 1 year at one of the 3 doses of Viaskin Milk: 150µg, 300µg, 500µg or placebo. After the first year, all subjects were to switch to the highest dose of Viaskin Milk, 500µg, and continue treatment in an open-label manner for up to a maximum of 3 additional years. Following results of the 12-month blinded period, all eligible subjects who wish to continue participation in the study will switch from Viaskin Milk 500µg to Viaskin Milk 300µg for 24 months of treatment. Eligible subjects with confirmed IgE-mediated CMA will perform a first Double-Blind Placebo-Controlled Food Challenge (DBPCFC) at screening with escalating doses of cow's milk proteins. Subjects showing a positive DBPCFC at screening, defined as the appearance of objective signs or symptoms to an eliciting dose of cow's milk proteins ≤300 mg (approximately ≤9.4mL of cow's milk) will be randomized in the study to receive a 12 month treatment (blinded treatment period), at which time a second DBPCFC will be performed to evaluate the primary efficacy endpoint of the study. Approximately 194 subjects will be randomized in this study. The total duration of participation in the study will differ for each individual subject and could be up to approximately 6 years.

Conditions

• Food Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Viaskin Milk 150 mcg	Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
BIOLOGICAL	Viaskin Milk 300 mcg	Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
BIOLOGICAL	Viaskin Milk 500 mcg	Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
BIOLOGICAL	Viaskin Placebo	Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-12-14
• Completion: 2020-12-22
• First posted: 2014-08-22
• Last updated: 2024-11-20
• Results posted: 2024-11-20

Locations

17 sites across 2 countries: United States, Canada