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Viaskin peanut patch safety in children ages 1 to 3

A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy

Phase 3 Interventional DBV Technologies · NCT07003919

This will test whether daily use of a 250 mcg Viaskin peanut patch is safe for children aged 1 to 3 with peanut allergy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment480 (estimated)
Ages1 Year to 3 Years
SexAll
SponsorDBV Technologies Industry-sponsored
Drugs / interventionsimmunotherapy
Locations90 sites (Birmingham, Alabama and 89 other locations)
Trial IDNCT07003919 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 trial that randomizes eligible 1–3 year-olds in a 3:1 ratio to receive DBV712 250 mcg or placebo for a 6-month blinded treatment period. Participants who complete the 6-month blinded period may join an optional 18-month open-label extension for longer-term exposure. Key entry requirements include physician-diagnosed peanut allergy, peanut-specific IgE > 0.7 kUA/L, a skin-prick wheal ≥ 6 mm, and a screening food challenge eliciting reactions at or below 300 mg peanut protein. The overall maximum participation time is about 112 weeks including screening, treatment, extension, and follow-up visits.

Who should consider this trial

Good fit: Ideal candidates are children aged 1–3 with physician-diagnosed peanut allergy who follow a strict peanut-free diet, have peanut-specific IgE > 0.7 kUA/L, a skin-prick wheal ≥ 6 mm, and a food challenge reaction threshold ≤ 300 mg peanut protein, and who have not received prior peanut immunotherapy.

Not a fit: Children with a history of severe peanut anaphylaxis, severe dermatologic disease at the proposed patch site, current or prior peanut immunotherapy, or recent treatment with biologic immunomodulators are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, this could support a safe, skin-applied option to reduce the risk of accidental peanut reactions and enable earlier treatment for very young children with peanut allergy.

How similar studies have performed: Prior clinical research of Viaskin Epicutaneous Immunotherapy in older children has shown signals of safety and modest desensitization but mixed efficacy results, so EPIT in very young children remains under active study.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Aged 1 through 3 years at Visit 1 (screening).
* Physician-diagnosed peanut allergy and following a strict peanut-free diet
* Peanut-specific IgE \> 0.7 kUA/L.
* A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
* An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).

Key Exclusion Criteria:

* Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
* Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
* Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
* History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
* Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
* Uncontrolled persistent asthma.

Where this trial is running

Birmingham, Alabama and 89 other locations

+40 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AllergyPeanut AllergyPeanut hypersensitivityEpicutaneous ImmunotherapyEpicutaneousImmunotherapyViaskinNut and Peanut Hypersensitivity
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.