Investigational Viaskin® Peanut therapeutic treatment is based on epicutaneous immunotherapy, or EPIT™. This potential new class of immunotherapey is designed to work by delivering allergens to the immune system through intact skin using our proprietary Viaskin® technology. Information on the Viaskin Platform is located here.
The REALISE (Real Life Use and Safety of EPIT) Phase 3 clinical trial in children 4 to 11 years of age, has completed recruitment (NCT 02916446). For children completing the REALISE clinical trial, an Expanded Access Program is available for the continued treatment with Viaskin® Peanut.
Requesting Expanded Access
All requests for Expanded Access must be made by a treating physician on behalf of the child and the child's parent or adult guardian. DBV Technologies has opened an Expanded Access Program for Viaskin® Peanut post-trial treatment. A treating physician may submit questions or requests regarding Expanded Access by emailing email@example.com or by calling Early Access Care at 203-441-7939 and speaking with an Early Access Coordinator. Requests will be acknowledged within one business day. No patient is guaranteed entry into the program solely by applying.
Physicians must follow local laws and regulations appropriate for the country originating the request.
Eligibility Criteria: In order to enroll in the Expanded Access Program, the physician must provide documentation of patient participation and completion in the REALISE study. Patients must provide informed consent for Expanded Access. Additionally, patients must be willing to continue following a strict peanut-free diet and carry an injectable epinephrine.
Safety Reporting: In addition to other obligations for safety reporting, as required by federal regulations, a written description of any serious adverse event (SAE), using the SAE reporting form, must be submitted to DBV Technologies within 24 hours after awareness of the event. Please submit SAE to: firstname.lastname@example.org