A Double Blind, Placebo-controlled, randomized Trial to Study the Viaskin Peanut’s Efficacy and Safety for Treating Peanut Allergy in Children and Adults.
Sponsor: DBV Technologies
SeaFAC Recruitment status: CLOSED
- To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg, 100 mcg, and 250 mcg of peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment
- To evaluate the safety of a long term treatment with Viaskin Peanut
DBV Technologies has developed a transcutaneous (“across the skin”) delivery system called Viaskin. This involves applying a patch to the skin so that the food protein is absorbed into the upper layers of the skin. By placing a new patch on the skin each day Viaskin can be used as a way to perform immunotherapy, and since the protein absorbed across the skin does not enter the blood stream directly, it may be safer than other forms of immunotherapy.
The VIPES study is a 12 month double-blind, placebo-controlled trial to study the efficacy and safety of Viaskin Peanut in subjects ages 6 to 55 with a history of immediate hypersensitivity reactions to peanut. The study is being conducted at approximately 20 sites around the world, including in the US, Canada, France, the Netherlands, and Poland. There is also plan to allow all patients who complete the VIPES study to enroll in a 2 year “open label extension” study using the optimal dose of Viaskin Peanut determined by the VIPES trial’s result. In this way all subjects, even those who were randomized to placebo in the VIPES study, will have potential to benefit from the Viaskin Peanut treatment.
The VIPES study will be completed in the summer of 2014.
For more detailed information about the VIPES study, please refer to the NIH Clinical Trials website: http://clinicaltrials.gov/ct2/show/NCT01675882