Phase 3 trial meets primary endpoint for VIASKIN Peanut patch in children aged 4–7 years

DBV Technologies announced positive topline results from VITESSE, a pivotal-phase 3 clinical trial evaluating the VIASKIN Peanut patch for the treatment of peanut allergy in children aged 4 to 7 years. The randomized, double-blind, placebo-controlled study met its primary efficacy endpoint, demonstrating a statistically significant treatment effect after 12 months of therapy. Safety findings were consistent with prior studies of the patch, and the company reported that a US Biologics License Application (BLA) submission remains on track for the first half of 2026.^1,2

Peanut allergy remains a common and potentially life-threatening condition in pediatric populations, with management historically centered on strict dietary avoidance and readiness to treat accidental exposures. These strategies can impose a substantial psychosocial and logistical burden on patients and families. Epicutaneous immunotherapy (EPIT), delivered via the VIASKIN Peanut patch, is designed to expose the immune system to microgram amounts of peanut protein through intact skin with the goal of inducing desensitization over time.

Phase 3 VITESSE trial evaluates epicutaneous immunotherapy for peanut allergy

VITESSE enrolled 654 children with peanut allergy at 86 sites across the United States, Canada, the United Kingdom, Europe, and Australia. Participants were randomized in a 2:1 ratio to receive either the active VIASKIN Peanut patch or a placebo patch. Enrollment exceeded the original target of 600 participants, and baseline demographic and disease characteristics were balanced between treatment arms.

The trial’s primary endpoint was defined as the difference in responder rates between treatment groups after 12 months of therapy. Response was assessed using double-blind, placebo-controlled food challenges, a standardized method for evaluating clinical reactivity to peanut protein.

Primary endpoint met with higher desensitization rates versus placebo

At 12 months, 46.6% of children treated with the VIASKIN Peanut patch met the prespecified responder criteria, compared with 14.8% of children in the placebo arm. The difference in response rates was 31.8%, with a 95% confidence interval of 24.5% to 39.0%, exceeding the prespecified lower bound threshold of 15%. The treatment effect was statistically significant, with a reported p value of less than 0.001.

Responders were defined as children with a baseline eliciting dose of 30 mg or less who achieved an eliciting dose of at least 300 mg of peanut protein at month 12, or children with a baseline eliciting dose of 100 mg who achieved an eliciting dose of at least 600 mg. The eliciting dose represents the amount of peanut protein that provoked an allergic reaction during food challenge testing.

Study defines clinically meaningful response thresholds in young children

The responder definitions used in VITESSE were selected to reflect clinically meaningful increases in peanut tolerance that could reduce the risk of reactions from accidental exposures. According to the company, responder rates across baseline eliciting dose subgroups performed as expected based on prespecified statistical projections, supporting the internal consistency of the findings.

Safety profile consistent with prior VIASKIN Peanut studies

Safety outcomes observed in VITESSE were consistent with the established safety profile of the VIASKIN Peanut clinical development program. The most commonly reported treatment-emergent adverse events were mild to moderate local skin reactions at the patch application site.

Discontinuations due to treatment-emergent adverse events were reported in 3.2% of participants in the active treatment group and 0.5% of participants in the placebo group. There were no reports of treatment-related serious adverse events. Treatment-related anaphylaxis occurred in 0.5% of treated children, and both participants continued therapy. Overall treatment compliance was high, reported at 96.2%.

Investigators highlight clinical relevance for pediatric allergy care

David Fleischer, MD, professor of pediatrics at Children’s Hospital Colorado and global principal investigator of the VITESSE study, emphasized the potential clinical implications of the results.

“Peanut allergy places a considerable burden on children and their families that is insufficiently addressed by current treatment options or strict avoidance,” Fleischer stated. “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.”

Allergy specialists note potential impact if approved

Cherie Zachary, MD, president of the American College of Allergy, Asthma and Immunology, commented on the broader significance of the findings for the allergy community.

“I am excited to see what’s possible with this innovative treatment in 4-7-year-old patients, if approved,” Zachary said. “I look forward to open-label results in the future to fully understand the potential impact VIASKIN Peanut can have in this age group.”

Breakthrough Therapy designation supports regulatory pathway

The VIASKIN Peanut patch previously received Breakthrough Therapy Designation from the US Food and Drug Administration. DBV Technologies reported that the planned BLA submission may be eligible for priority review, reflecting the agency’s recognition of the unmet need in pediatric peanut allergy.

Daniel Tassé, CEO of DBV Technologies, described the VITESSE trial as a major milestone for the program. “VITESSE is the largest immunotherapy clinical trial ever conducted in food alle,rgy and we are thrilled that the resulting clinical evidence supporting the VIASKIN Peanut patch is robust,” Tassé stated. “With these data in hand, I am looking forward to submitting the BLA to the FDA, as planned, in the first half of 2026.”

FDA biologics license application planned for first half of 2026

Following completion of the 12-month double-blind period, participants were offered enrollment in an open-label extension in which all children received the active patch for up to 3 years of total treatment. DBV Technologies reported that enrollment in the extension phase has been consistent with prior phase 3 studies.

The company plans to present full VITESSE results at future medical congresses and submit the data for publication in a peer-reviewed journal. If approved, the VIASKIN Peanut patch could offer a non-invasive immunotherapy option for young children with peanut allergy, addressing a longstanding gap in pediatric allergy management.

References

1. DBV Technologies. DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years. Global Newswire. December 17, 2025. Accessed December 17, 2025. https://www.globenewswire.com/news-release/2025/12/16/3206604/0/en/DBV-Technologies-Announces-Positive-Topline-Results-from-Phase-3-VITESSE-Trial-of-VIASKIN-Peanut-Patch-in-Peanut-Allergic-Children-Aged-4-7-Years.html
2. Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age (VITESSE). Updated December 4, 2024. Accessed Decemeber 17, 2205. https://clinicaltrials.gov/study/NCT05741476?cond=peanut%20allergy&term=VITESSE&intr=viaskin&rank=1