Date: 2016-11-08
Type of information: Completion of patient enrollment
phase: 2
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: cow milk allergy
Therapeutic area: Allergic diseases
Country: Canada, USA
Trial
details: The MILES trial is a multi-center, double-blind, placebo-controlled, randomized Phase I/II trial to study the safety and efficacy of Viaskin® Milk in pediatric patient populations (age two to 17) suffering from IgE-mediated cow’s milk protein allergy, or CMPA, with elevated IgE levels related to cow’s milk protein. The trial is being conducted in select U.S. and Canadian clinical centers. Part A of the MILES trial has been completed. Under the proposed amended MILES Part B protocol, up to 176 subjects are expected to be randomized for treatment at approximately 18 sites. Eligible subjects with confirmed IgE-mediated CMPA will perform an initial food challenge at screening with escalating doses of cow’s milk proteins. Subjects who display objective signs or symptoms of allergic response to an eliciting dose of 300 mg cow’s milk proteins (approximately 9.4 mL of cow’s milk) or below will be randomized in the trial. The primary efficacy endpoint will be the percentage of subjects who are treatment responders after 12 months, defined as subjects who meet at least one of the following criteria: (1) a 10-fold or greater increase in the cumulative reactive dose, or CRD, of cow’s milk proteins at month 12 of the food challenge as compared to baseline value in addition to reaching tolerance to at least 144 mg of cow’s milk protein (approximately 4.5 mL of milk) or (2) a CRD of cow’s milk protein greater than or equal to 1,444 mg (approximately 45 mL of milk) at month 12 of the food challenge. Secondary efficacy endpoints include, among others, the percentage of subjects who are treatment responders at month 24, the mean and median CRD of cow’s milk proteins at months 12 and 24 as well as the change in CRD from baseline, the change from baseline in the severity of symptoms elicited during the food challenge from baseline to months 12 and 24, and the change from baseline in quality of life assessments at months 12 and 24. (NCT02223182)
Latest
news: * On November 8, 2016, DBV Technologies announced that enrollment for Part B, or Phase II, of the Phase I/II study of Viaskin Milk for the treatment of patients with IgE-mediated cow’s milk protein allergy (CMPA) has been completed. The blinded part of the MILES study is expected to complete in the second half of 2017. No safety concerns were observed during Part A of the MILES Study (Phase I). In Phase II, or Part B of the MILES study, a total of 283 patients were screened. The Company expects approximately 176 children with IgE-mediated CMPA will be randomized 1:1:1:1 to receive one of the three doses of Viaskin Milk (150 µg, 300 µg, 500 µg) or placebo for 12 months. * On October 14, 2015, DBV Technologies announced that it has begun enrolling cow’s milk-allergic subjects in the Part B (Phase II) of the MILES Phase I/II study (Viaskin MILk Efficacy and Safety). In Phase II, or Part B of the MILES study, 176 children with IgE-mediated cow’s milk allergy (CMA) will be randomized 1:1:1:1 to receive one of the three doses of Viaskin® Milk (150 µg, 300 µg, 500 µg) or placebo for 12 months. Responders will be defined as subjects who meet one of the following criteria: a 10-fold or greater increase in the cumulative reactive dose (CRD) of cow’s milk proteins at the month-12 food challenge as compared to the baseline value and reaching at least 144 mg of cow’s milk proteins (approximately 4.5 mL of milk); or a CRD of cow’s milk proteins equal
or greater than 1444 mg (approximately 45 mL of milk) at the month-12 food challenge.
* On June 30, 2015, DBV Technologies announced the completion of Phase I or Part A, of the Viaskin® Milk Efficacy and Safety Phase I/II study (MILES). The Data Safety Monitoring Board (DSMB) for the study recommended that the study continue and expressed no safety concerns after evaluating the Part A safety data of subjects treated with a 150 microg, 300 microg and 500 microg doses of Viaskin® Milk. The MILES study is a two part, multi-center, double-blind, placebo-controlled, randomized clinical trial designed to evaluate the safety and efficacy of Viaskin® Milk in IgE-mediated cow’s milk protein allergic (CMPA) patients ranging from two to 17 years of age. Part A evaluated the safety of three escalating doses of Viaskin® Milk (150 ?g, 300 ?g and 500 ?g) versus placebo over three weeks in 18 patients. Pending review of the Part A data by the FDA and U.S. and Canadian approvals of the revised protocol described below, the Company intends to initiate Part B of the trial in the second half of 2015. Part B, or Phase II, of the MILES study is expected evaluate the efficacy and safety of all three doses of Viaskin® Milk (150 µg, 300 µg, 500 µg) versus placebo for 12 months. Approximately 176 patients between two and 17 years of age are expected to be randomized in a 1:1:1:1 ratio at selected North American sites.
