A Phase Ib trial to evaluate the safety and tolerability of repeated epicutaneous administration of Viaskin® Peanut in patients allergic to peanuts.
In the trial, which was conducted at five leading centers in the United States, 100 subjects (initially adults, followed by adolescents and then children) allergic to peanuts, including 70 with a non-severe allergy and 30 with a severe allergy, were randomized and treated for two weeks with 20 µg to 500 µg of Viaskin® Peanut or with placebo. The primary endpoint of this clinical trial was safety, with the primary safety parameters of adverse events, physical examinations, vital signs, lab values, allergic reactions, any skin reactions, local or distant, echo-cardiogram, and Peak Expiratory Flow and spirometry (FEV1). Secondary endpoints included the proportion of subjects that experience systemic reactions such as urticaria, asthma and acute dyspnea, change in blood pressure, and digestive symptoms (vomiting, diarrhea) associated with Viaskin® Peanut treatment versus placebo, the proportion of subjects requiring treatment for systemic reactions related to Viaskin® Peanut treatment or placebo, and overall adherence to the clinical trial treatment.
In the overall population, the dose of 500 µg of Viaskin® Peanut in adults and adolescents, and the dose of 250 µg of Viaskin® Peanut in children, were shown to be well-tolerated maximum doses regardless of the administration plan. Importantly, an excellent treatment compliance rate (> 96%) was observed and the intermediate results suggested satisfactory usage safety of Viaskin® Peanut in patients allergic to peanuts. The interim report was communicated to the FDA on December 15, 2011, and DBV Technologies released the complete results of this clinical trial at the EAACI Congress in June 2012.
The FDA granted DBV Technologies, a clinical-stage specialty biopharmaceutical company based in Bagneux, France Breakthrough Designation (BTD) to its Viaskin Peanut for children. This BTD followed the positive results from the Phase IIb trial that demonstrated significant improvement among children with peanut allergy disease treated with Viaskin Peanut. Peanut allergy is a major type of […]