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Clinical Trials & Research

Explore ongoing and completed trials of the investigational VIASKIN® Peanut Patch in infants, toddlers, and children with peanut allergy. View study designs, populations, and links to trial registries and available publications.

Active and Completed Trials

DBV is committed to advancing the science of food allergy treatment, starting with peanut allergy.

Select each trial for more information.

6-12 months

1-3 years

EPOPEX6,7

Complete

ClinicalTrials.gov: NCT03859700

Publication: Greenhawt M et al, J Allergy Clin Immunol Pract (2025).

View details for EPOPEX

4-7 years

Completed Phase 3 Studies of the VIASKIN Peanut Patch in Children Aged 4 to 11 Years10-12

Three phase 3 studies evaluated the efficacy and long-term safety of the VIASKIN Peanut Patch in this age group: PEPITES, PEOPLE (an open-label extension of PEPITES), and REALISE.11-13 Findings from these studies informed the current clinical strategy, now focused on toddlers and younger children.1

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References:
  1. 1. DBV Technologies. Corporate presentation, July 2026. Accessed November 6, 2026. https://dbv-technologies.com/wp-content/uploads/2026/07/DBV_Investor_Presentation-July_2026.pdf
  2. 2. ISRCTN.com identifier: ISRCTN63504081 (THRIVE). Accessed November 2, 2026. https://www.isrctn.com/ISRCTN63504081
  3. 3. Safety Study of Viaskin® Peanut Patch in peanut-allergic children 1 through 3 years of age (COMFORT Toddlers). ClinicalTrials.gov identifier: NCT07003919. Accessed October 22, 2026. https://clinicaltrials.gov/study/NCT07003919
  4. 4. Safety and efficacy study of VIASKIN Peanut in peanut allergic young children 1-3 years of age (EPITOPE). ClinicalTrials.gov identifier: NCT03211247. Accessed November 2, 2026. https://clinicaltrials.gov/study/NCT03211247
  5. 5. Greenhawt M, Sindher SB, Wang J, et al. Phase 3 trial of epicutaneous immunotherapy in toddlers with peanut allergy. N Engl J Med. 2023;388(19):1755-1766.
  6. 6. Follow-up of the EPITOPE study to evaluate long-term efficacy and safety of DBV712 in young children (EPOPEX). ClinicalTrials.gov identifier: NCT03859700. Accessed November 2, 2026. https://clinicaltrials.gov/study/NCT03859700
  7. 7. Greenhawt M, Albright D, Anvari S, Arends N, Arkwright PD, Bégin P, et al. Efficacy and safety of epicutaneous immunotherapy in peanut-allergic toddlers: open-label extension to EPITOPE. J Allergy Clin Immunol Pract. 2025;13(5):1176-1187.e7.
  8. 8. Safety and efficacy study of Viaskin Peanut in peanut-allergic children 4-7 years of age (VITESSE). ClinicalTrials.gov identifier: NCT05741476. Accessed November 3, 2026. https://clinicaltrials.gov/study/NCT05741476
  9. 9. Fleischer DM, Mack DP, Wang J, et al. VITESSE phase 3 study: efficacy and safety of epicutaneous immunotherapy in peanut-allergic children 4 through 7 years of age. Presented at American Academy of Allergy, Asthma, & Immunology Annual Meeting. February 27 to March 2, 2026, Philadelphia, PA.
  10. 10. Fleischer DM, Greenhawt M, Sussman G, et al. Effect of epicutaneous immunotherapy vs placebo on reaction to peanut protein ingestion among children with peanut allergy: the PEPITES randomized clinical trial. JAMA. 2019;321(10):946-955.
  11. 11. Fleischer DM, Shreffler WG, Campbell DE, et al. Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results. J Allergy Clin Immunol. 2020;146(4):863-874.
  12. 12. Pongracic JA, Gagnon R, Sussman G, et al. Long-term safety of epicutaneous immunotherapy in peanut-allergic children: an open-label active treatment (REALISE study). J Allergy Clin Immunol Pract. 2025;13(5):1190-1200.e3.
  13. 13. Efficacy and safety of Viaskin Peanut in children with immunoglobulin E (IgE)-mediated peanut allergy (PEPITES). ClinicalTrials.gov identifier: NCT02636699. Accessed November 2, 2026. https://clinicaltrials.gov/study/NCT02636699
  14. 14. Follow-up of the PEPITES study to evaluate long-term efficacy and safety of Viaskin Peanut in children (PEOPLE). ClinicalTrials.gov identifier: NCT03013517. Accessed November 2, 2026. https://clinicaltrials.gov/study/NCT03013517
  15. 15. Safety study of Viaskin Peanut to treat peanut allergy (REALISE). ClinicalTrials.gov identifier: NCT02916446. Accessed November 2, 2026. https://clinicaltrials.gov/study/NCT02916446

Epicutaneous immunotherapy is under clinical investigation and has not yet been approved by any health or regulatory authority.

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