Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
EPOPEX
EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children
1 other identifier
interventional
304
1 country
26
Brief Summary
Open-label, follow-up study for subjects who completed the EPITOPE study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2018
Longer than P75 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2018
CompletedFirst Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2025
CompletedJune 6, 2025
June 1, 2025
6.4 years
February 19, 2019
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of subjects reaching an ED ≥1000 mg
12 months
Proportion of subjects reaching an ED ≥1000 mg
24 months
Proportion of subjects reaching an ED ≥1000 mg
36 months
Secondary Outcomes (1)
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Throughout the study during 36 months
Study Arms (1)
DBV712 250mcg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- completion of the EPITOPE study
You may not qualify if:
- Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
- Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DBV Technologieslead
Study Sites (26)
Banner University Medical Center Tucson
Tucson, Arizona, 85724-5030, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
David Geffen School of Medicine at University of California Los Angeles
Los Angeles, California, 90095, United States
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
University of California San Francisco
San Francisco, California, 94158, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Health Center
Washington D.C., District of Columbia, 20010, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Comer Children's Hospital
Chicago, Illinois, 60637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Boston Childrens' Hospital
Boston, Massachusetts, 02115, United States
University of Michigan - Allergy Specialty Clinic and Food Allergy Clinic
Ann Arbor, Michigan, 48106, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of Rochester
Rochester, New York, 14642, United States
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, 27599, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37204, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Seattle Allergy & Asthma Research Institute
Seattle, Washington, 98115, United States
Related Publications (2)
Greenhawt M, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris S, Dorsey M, Du Toit G, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, O'B Hourihane J, Jay N, Jones SM, Kim EH, Kloepfer K, Leonard S, Lezmi G, Lieberman J, Lomas J, Makhija M, O'Sullivan M, Parrish C, Peake J, Perrett KP, Petroni D, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma H, Sindher SB, Trujillo J, Turner PJ, Tuttle K, Upton J, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wang J, Wood R, Bee KJ, Campbell DE, Green TD, Rouissi R, Bahnson HT, Bois T, Sampson HA, Burks AW. Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE. J Allergy Clin Immunol Pract. 2025 May;13(5):1176-1187.e7. doi: 10.1016/j.jaip.2025.02.004. Epub 2025 Feb 14.
PMID: 39956162DERIVEDGreenhawt M, Sindher SB, Wang J, O'Sullivan M, du Toit G, Kim EH, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Bourrier T, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris SL, Dorsey MJ, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, Giovannini-Chami L, Hourihane JO, Jay N, Jones SM, Kerns LA, Kloepfer KM, Leonard S, Lezmi G, Lieberman JA, Lomas J, Makhija M, Parrish C, Peake J, Perrett KP, Petroni D, Pfutzner W, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma HP, Trujillo J, Turner PJ, Tuttle K, Upton JE, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wood RA, Bee KJ, Campbell DE, Green TD, Rouissi R, Peillon A, Bahnson HT, Bois T, Sampson HA, Burks AW. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. N Engl J Med. 2023 May 11;388(19):1755-1766. doi: 10.1056/NEJMoa2212895.
PMID: 37163622DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2019
First Posted
March 1, 2019
Study Start
December 6, 2018
Primary Completion
May 13, 2025
Study Completion
May 13, 2025
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share