Epicutaneous Immunotherapy Patch Reduces Peanut Reactivity in Children, Phase 3 Data Show

DBV Technologies announced positive topline results from the Phase 3 VITESSE trial evaluating the VIASKIN Peanut patch for the treatment of peanut allergy in children aged 4 to 7 years, with the study meeting its primary efficacy endpoint.

"Peanut allergy places a considerable burden on children and their families that is insufficiently addressed by current treatment options or strict avoidance,” David Fleischer, MD, Professor of Pediatrics at Children’s Hospital Colorado and Global Principal Investigator of the VITESSE study, said in a press release. “I’m thrilled by these topline results which show a statistically significant treatment effect in children treated with the VIASKIN Peanut patch. The levels of desensitization achieved in this study after one year on treatment are highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option that I believe would be welcomed into pediatric care. As a practicing allergist, I look forward to what that may mean for families managing peanut allergy every day and hope to be able to implement this treatment in my clinic, if approved.”

VITESSE was a global, randomized, double-blind, placebo-controlled Phase 3 trial (NCT05741476) enrolling 654 children with peanut allergy. Participants were randomized 2:1 to receive either the VIASKIN Peanut patch delivering 250 µg of peanut protein or placebo for 12 months. A total of 438 children were assigned to the active treatment arm and 216 to placebo, exceeding the original enrollment target of 600 patients. Baseline demographic and disease characteristics were balanced between treatment groups.

The primary endpoint was the difference between treatment arms in the proportion of responders at 12 months. Responders were defined as children with a baseline eliciting dose (ED) of ≤30 mg who achieved an ED of ≥300 mg of peanut protein at month 12, or children with a baseline ED of 100 mg who achieved an ED of ≥600 mg, as measured by a double-blind, placebo-controlled food challenge.

At 12 months, 46.6% of children treated with the VIASKIN Peanut patch met responder criteria compared with 14.8% of children receiving placebo, yielding a difference in response rates of 31.8% (95% CI, 24.5%-39.0%). The lower bound of the 95% confidence interval exceeded the prespecified threshold of 15%, meeting the primary endpoint. The treatment effect was statistically significant (p < .001).

Safety findings in VITESSE were consistent with those observed across the VIASKIN Peanut clinical development program. The most common treatment-emergent adverse events were mild-to-moderate local skin reactions at the patch application site. Discontinuations due to treatment-emergent adverse events occurred in 3.2% of children in the active treatment arm and 0.5% of those in the placebo arm. There were no reports of treatment-related serious adverse events, and treatment-related anaphylaxis occurred in 0.5% of treated children (n=2); both patients continued treatment. Overall treatment compliance was 96.2%.

VITESSE was conducted across 86 clinical sites in the United States, Canada, the United Kingdom, Europe, and Australia and represents the largest immunotherapy clinical trial conducted in food allergy to date, according to the company. Following completion of the 12-month double-blind period, participants were offered enrollment in an open-label extension in which all children receive VIASKIN Peanut patch for up to a total of three years of treatment.

DBV Technologies stated that it plans to submit a Biologics License Application to the US Food and Drug Administration in the first half of 2026. The VIASKIN Peanut patch has previously received FDA Breakthrough Therapy Designation, and the company indicated the application may be eligible for priority review.

Reference: DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years. DBV Technologies. News release. December 16, 2025. Accessed December 17, 2025. https://dbv-technologies.com/press_releases/dbv-technologies-announces-positive-topline-results-from-phase-3-vitesse-trial-of-viaskin-peanut-patch-in-peanut-allergic-children-aged-4-7-years/