Eosinophilic Esophagitis Clinical Trial
Official title:
A Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children
This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.
This is a double-blind, placebo-controlled, randomized trial to study the efficacy and safety
of Viaskin® Milk, an allergen extract of milk administered epicutaneously using the Viaskin®
epicutaneous delivery system (EPIT) in subjects from 4 to 17 years old with a milk induced
Eosinophilic Esophagitis. Subjects will be randomized in a 3:1 ratio into two different
treatment groups, to receive EPIT with Viaskin® Milk (500 µg of milk proteins) or placebo.
Subjects who complete the double-blind treatment period (approximately 11 months), will
automatically rollover into an open label treatment period (additional 11 months). All
subjects will receive the 500 µg (micrograms) Viaskin Milk patch.
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