Date: 2017-02-03
Type of information: Completion of patient enrollment
phase: 2a
Announcement: completion of patient enrollment
Company: DBV Technologies (France)
Product: Viaskin® Milk
Action
mechanism: immunotherapy product. Viaskin® is an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.
Disease: milk-induced eosinophilic esophagitis
Therapeutic area: Allergic diseases - Inflammatory diseases
Country: USA
Trial
details: SMILEE is a double-blind, placebo-controlled, randomized 3:1 trial designed to evaluate the safety and efficacy of Viaskin® Milk 500 ?g for treating milk-induced EoE in children. Subjects with a documented medical history of EoE after ingestion of milk who currently adhere to a strict milk-free diet will be considered for participation in the trial. Approximately 20 subjects, 15 in the active treatment group and five in the placebo group, will be randomized and treated for nine months while remaining on a milk-free diet. The subjects will then continue their assigned treatment during a milk reintroduction period (1 week to 2 months), for a total of up to 11 months of treatment. The primary efficacy endpoint will evaluate the maximum esophageal eosinophil count in the active treatment group compared to placebo at the end of treatment. Secondary efficacy endpoints will include the change in symptoms score at the end of treatment compared to baseline and mean esophageal eosinophil count at the end of treatment. The trial is being conducted under an Investigational New Drug (IND) application held by Dr.
Jonathan Spergel at Children’s Hospital of Philadelphia (CHOP).(NCT02579876)
Latest
news: * On February 3, 2017, DBV Technologies announced that enrollment in SMILEE (Study of Efficacy and Safety of the Viaskin MILk in MilkInduced Eosinophilic Esophagitis in Children), a Phase IIA investigator-initiated clinical trial assessing the safety and efficacy of Viaskin Milk for the treatment of milk-induced Eosinophilic Esophagitis (EoE) in children ages 4-17 has been completed. In this study, 20 children with milk-induced EoE
have been randomized 3:1 to receive Viaskin Milk 500 µg or placebo for up to 11 months. Results for
the SMILEE study are expected in the first half of 2018.
* On November 12, 2015, DBV Technologies announced that the first patient has been enrolled in SMILEE (Study of efficacy and safety of the Viaskin® MILk in Milk-Induced Eosinophilic Esophagitis), a Phase IIA clinical trial assessing the safety and efficacy of Viaskin® Milk for the treatment of milk allergy-induced Eosinophilic Esophagitis (EoE) in children ages 4-17. The SMILEE trial is conducted under an Investigational New Drug (IND) application held by Dr. Jonathan Spergel at The Children’s Hospital of Philadelphia.
* On July 8, 2015, DBV Technologies announced that the FDA has accepted an investigator-sponsored investigational new drug (IND) application for a Phase IIA clinical trial for the potential treatment of milk-induced eosinophilic esophagitis (EoE) in children using the Company’s Viaskin® Milk. This IND acceptance enables Dr. Jonathan Spergel at The Children’s Hospital of Philadelphia to initiate SMILEE (Study Efficacy and Safety of the Viaskin® Milk in milk-induced Eosinophilic Esophagitis), a clinical trial designed to assess the efficacy and safety of Viaskin® Milk in children four to 17 years of age suffering from milk-induced EoE. The SMILEE trial is expected to begin in the second half of 2015. SMILEE is expected to be a double-blind, placebo-controlled, randomized 3:1 trial designed to evaluate the safety and efficacy of Viaskin® Milk 500 ?g for treating milk-induced EoE in children. Subjects with a documented medical history of EoE after ingestion of milk who currently adhere to a strict milk-free diet will be considered for participation in the trial. Approximately 20 subjects, 15 in the treatment group and five in the placebo group, will be randomized and treated for nine months while remaining on a milk-free diet. The treatment group will then continue the trial during a milk reintroduction period (1 week to 2 months), for a total of up to 11 months of treatment. The primary efficacy endpoint will be evaluated as the maximum esophageal eosinophil count in the treatment group compared to placebo at the end of treatment. Secondary efficacy endpoints will include the change in symptoms score at the end of treatment compared to baseline and mean esophageal eosinophil count at the end of treatment.
