Principal Investigator, Dr. Dareen Siri, FAAAAI, FACAAI from Midwest Allergy Sinus Asthma, in Normal and Springfield, Illinois was the first to conduct a screening visit for a potential new enrollee.
“I am thrilled that our talented team of clinicians was the first to screen a patient for the VITESSE clinical study,” said Dareen Siri, MD, Midwest Allergy Sinus Asthma, Normal, IL. “The initiation of patient enrollment in VITESSE reinforces our commitment to peanut-allergic children and their families and is an important step in generating the data needed to potentially advance Viaskin Peanut to market. I am grateful that peanut-allergic children have the opportunity to participate in a trial that may one day help other kids just like them living with peanut allergy. There is a lot of excitement around the VITESSE study, and I am proud our team will be an integral part of it.”
DBV anticipates screening the last patient in 1H 2024 and announcing topline results in 1H 2025.
About VITESSE
The VITESSE trial will enroll 600 subjects, randomized 2:1 active versus placebo. The study will involve approximately 80 trial sites across the United States, Canada, Australia and Europe. Dr. David Fleischer, Colorado Children’s Hospital, will act as the global study Principal Investigator.
The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at Month 12. The primary efficacy analysis includes the success criterion of a lower bound of the confidence interval of the difference in responder rates between active and placebo groups being greater than or equal to 15%.
A treatment responder is defined as either a subject with a baseline ED ≤30 mg who reaches an ED ≥300 mg of peanut protein at Month 12, or a subject with a baseline ED = 100 mg who reaches an ED ≥600 mg of peanut protein at Month 12. A double-blind, placebo-controlled food challenge (DBPCFC) will be administered at baseline and Month 12 to determine a subject’s ED at both timepoints.
During the screening period, subjects will undergo an initial visit with assessment for eligibility according to peanut skin prick test (SPT) and serum peanut IgE. Those meeting these criteria will proceed to a DBPCFC to confirm their peanut allergy and establish an entry peanut ED. The entry DBPCFC will be 1 mg peanut protein, and will escalate up to a highest single dose of 100 mg peanut protein. Subjects who react with an ED at or below the dose of 100 mg peanut protein and meet all other inclusion and no exclusion criteria are considered eligible. At Month 12, a post-treatment DBPCFC will be performed, with a starting dose of 3 mg peanut protein, escalating to a highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, 1,000 mg. Secondary efficacy endpoints include changes in CRD, ED and severity of allergic reaction at Month 12 food challenge.
