DBV Technologies Screens First Infant in THRIVE Peanut Patch Trial

DBV Technologies announced the first participant has been screened in THRIVE, a phase 2 study evaluating the Viaskin Peanut patch in infants aged 6 through 12 months with peanut allergy, with principal investigator Douglas Mack, MD, assistant clinical professor in the department of pediatrics at McMaster University, screening the first participant.1

The single-arm, open-label study will assess the efficacy and safety of daily epicutaneous immunotherapy (EPIT) via the Viaskin Peanut patch in this youngest-ever population enrolled in a peanut allergy trial of this scale. All participants will wear the patch daily for 36 months while maintaining a peanut-free diet, followed by a peanut food challenge to determine the consumption regimen for months 37 through 48.1

The primary endpoint is ad libitum peanut consumption, defined by prespecified criteria including tolerated single-sitting intake, longitudinal consumption patterns, and caregiver-reported outcomes. Mack said choosing ad lib consumption as the bar reflects an ambition beyond desensitization alone.1

"Ad lib, to me, is the next stage in this," Mack said. "If we can induce not just a desensitization but help these kids function not dissimilar to children that were never allergic in the first place, to me that's a marker of true long-term change, remission, tolerance, whatever you want to call this.”

Mack also addressed a practical question around the preverbal status of infants at enrollment. Because the ad lib consumption assessment occurs in the fourth year of the study, most participants will be fully verbal by that point, making caregiver and patient-reported outcomes feasible.

THRIVE builds on results from earlier DBV trials in toddlers aged 1 through 3 years (EPITOPE) and children aged 4 through 7 years (VITESSE), which demonstrated desensitization benefits.2,3 Mack noted the 3-year data from older cohorts already supports the biological plausibility of treating this age group but said the window being targeted here is distinct.

"If we are going to induce long-term change for these patients, we need to start early and capitalize on this early window," he said. "THRIVE will collect valuable data by assessing these patients between 6 and 12 months of age, earlier than we've ever done it. It really makes it the earliest peanut-allergic group we've ever assessed in a clinical trial of this size using EPIT."

On practical considerations, Mack said the counseling burden for families is real but manageable. He drew a parallel to LEAP-era conversations around peanut exposure in early life, noting that most peanut-allergic infants are already living peanut-free. He also pointed out that patch adherence concerns familiar from older cohorts may be less pronounced in this age group, since infants lack the coordination to remove the patch themselves and have lower activity levels in the first year.

Safety monitoring will focus on local site reactions, the most consistently observed adverse event across Viaskin trials. Mack said he does not anticipate anaphylaxis given the low allergen dose, roughly 1/1000 of a peanut, and expects the tolerability profile to mirror what has been seen in prior studies.

Looking ahead, Mack described a potential shift in clinical practice if THRIVE data are positive: moving toward immediate treatment at diagnosis rather than watchful waiting.

“I think what we’re going to see is a movement toward very early treatment, almost like a salvage, so the patient has a reaction, they get tested, and we move straight to an active treatment,” he said. "For many families, [oral immunotherapy] doesn't work [due to] picky eaters, preexisting eosinophilic esophagitis, [and] uncontrolled asthma. We offer both oral immunotherapy and clinical trial patch immunotherapy, and we have a lot of families who are choosing the patch.”

Mack has no reported disclosures.

References

1. DBV Technologies Announces First Participant Screened in THRIVE Phase 2 Study of the VIASKIN® Peanut Patch in Infants ages 6 through 12 Months with Peanut Allergy | DBV Technologies. Dbv-technologies.com. Published June 2, 2026. Accessed June 11, 2026. https://dbv-technologies.com/press_releases/dbv-technologies-announces-first-participant-screened-in-thrive-phase-2-study-of-the-viaskin-peanut-patch-in-infants-ages-6-through-12-months-with-peanut-allergy/

2. Derman C. Viaskin Patch Effective in Peanut-Allergic Kids with Atopic Comorbidities. HCPLive. Published April 17, 2025. Accessed June 11, 2026. https://www.hcplive.com/view/viaskin-patch-effective-in-peanut-allergic-kids-with-atopic-comorbidities

3. Fleischer D. VIASKIN Peanut Patch Shows Strong Phase 3 VITESSE Results, With David Fleischer, MD. HCPLive. Published March 23, 2026. Accessed June 11, 2026. https://www.hcplive.com/view/viaskin-peanut-patch-shows-strong-phase-3-vitesse-results-david-fleischer-md.