Trial Profile
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 19 Sep 2025
Price :
$35
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At a glance
- Drugs Peanut allergy immunotherapy (Primary) ; Arachis hypogaea oil
- Indications Peanut hypersensitivity
- Focus Registrational; Therapeutic Use
- Acronyms VITESSE
- Sponsors DBV Technologies
Most Recent Events
- 29 Jul 2025 According to a DBV Technologies media release, VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of the warrants, resulting in an aggregate funding of up to $181.4 million to finance the continued development of the Viaskin Peanut program, which will be used to finance the preparation and submission of a potential BLA, and to finance the readiness of a launch of Viaskin peanut in the U.S., if approved.
- 28 Mar 2025 According to a DBV Technologies media release, company announced financing of up to 306.9 Million (284.5 Million) to Advance Viaskin Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch
- 24 Mar 2025 According to a DBV Technologies media release,the company secured agreement with the U.S. Food and Drug Administration (FDA) on safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 to7 year olds will be sufficient to support a Biologics License Application (BLA) filing in this age group, and the COMFORT Children supplemental safety study will no longer be required.The BLA expected to be submitted 1H 2026.