DBV Technologies Completes Screening for the VITESSE Phase 3 Clinical Trial
Tuesday, September 24, 2024
DBV Technologies, a clinical-stage biopharmaceutical company, today announced that patient screening is complete for the Phase 3 trial, VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), using the modified Viaskin Peanut Patch in children ages 4 – 7 years old with peanut allergy.
“We are thrilled to have reached this significant milestone,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “VITESSE is by far the largest immunotherapy clinical trial for this patient population. I cannot thank our study centers enough for their dedication and commitment to DBV’s Viaskin® peanut patch program. Of course, none of this is possible without our subjects and their supportive families. Being in a clinical trial takes a tremendous amount of time, and we are grateful that subjects are willing to make this sacrifice to further treatments in food allergy. I’m delighted that we closed screening in August, a month earlier than anticipated. I am particularly pleased with our success in reaching out to the diverse communities that suffer from peanut allergies in this trial. DBV continues to focus on advancing this important development program to support a Biologic License Application submission. We look forward to continued collaboration with our shared stakeholders as we move ahead.”
The fully enrolled VITESSE Phase 3 trial in peanut-allergic children ages 4 – 7 is a 12-month study evaluating the efficacy and safety of the Viaskin Peanut Patch in more than 600 subjects (randomized 2:1), representing individuals across 86 sites in the U.S., Canada, Europe, the UK, and Australia. VITESSE is currently the largest treatment intervention study in peanut allergy.
Source: globenewswire.com
