Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
EPITOPE
A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
1 other identifier
interventional
414
8 countries
51
Brief Summary
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
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 Jul 2017
Longer than P75 for phase_3
51 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
First Submitted
Initial submission to the registry
July 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 7, 2017
CompletedStudy Start
First participant enrolled
July 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2022
CompletedResults Posted
Study results publicly available
December 16, 2024
CompletedDecember 16, 2024
December 1, 2024
2.1 years
July 5, 2017
February 20, 2024
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Treatment Responders at Month 12
A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
Month 12
Secondary Outcomes (5)
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
Month 12
Change From Baseline in CRD of Peanut Protein to Month 12
Baseline (Day 1) and Month 12
ED of Peanut Protein at Month 12 Using ANCOVA Model
Month 12
Change From Baseline in ED of Peanut Protein to Month 12
Baseline (Day 1) and Month 12
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Baseline (Day 1) and Month 12
Study Arms (5)
Part A Viaskin Peanut 250 mcg
EXPERIMENTALPart A Viaskin Peanut 100 mcg
EXPERIMENTALPart A Placebo
PLACEBO COMPARATORPart B Viaskin Peanut 250 mcg
EXPERIMENTALPart B Placebo
PLACEBO COMPARATORInterventions
Viaskin Peanut 250 mcg, once daily
Viaskin Peanut 100 mcg, once daily
Viaskin Peanut 250 mcg, once daily
Eligibility Criteria
You may qualify if:
- Male or female from 1-3 years of age;
- Physician-diagnosed peanut allergy;
- Peanut-specific IgE level \> 0.7 kU/L;
- Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
- Positive DBPCFC at ≤ 300 mg peanut protein;
You may not qualify if:
- Uncontrolled asthma;
- History of severe anaphylaxis to peanut;
- Prior immunotherapy to any food or other immunotherapy;
- Generalized severe dermatologic disease;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DBV Technologieslead
Study Sites (51)
University of Arizona Health Science
Tucson, Arizona, 85719, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
University of California School of Medicine
Los Angeles, California, 10833, United States
University of California, Rady Children's Hospital
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 System
Washington D.C., District of Columbia, 20010, United States
Emory University
Atlanta, Georgia, 30329, United States
Ann & Robert H. Lurie Children's Hospital of CHicago
Chicago, Illinois, 60611, United States
The Universal of Chicago Medical Center
Chicago, Illinois, 60637, United States
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Boston Childrens' Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Health System
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
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030, United States
ASTHMA, Inc.
Seattle, Washington, 98115, United States
The Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
Sydney Children's Hospital
Randwick, NWS, 2031, Australia
Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
The Women's and children's hospital
North Adelaide, South Australia, 5006, Australia
The Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Perth Children's Hospital
Nedlands, Western Australia, 6009, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, V5H 3V4, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
CHUM & CHU Sainte-Justine
Montreal, Quebec, H3T 1C4, Canada
CHRU Lille
Lille, 59037, France
CHRU Metz-Thionville
Metz, 57085, France
Hopitaux Pediatriques de Nice
Nice, 06200, France
Hopital Necker
Paris, 75015, France
CHRU Nancy
Vandœuvre-lès-Nancy, 54511, France
Universitatsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Universitatsklinikum Frankfurt
Frankfurt, 60590, Germany
Universitatklinikum Giessen und Marburg
Marburg, 35033, Germany
Cork University Hospital
Cork, T12YE02, Ireland
Erasmus MC Sophia Children's Hospital
Rotterdam, 3015, Netherlands
Guy's and Saint Thomas' NHS Foundation Trust
London, SE17EH, United Kingdom
St.Mary's Hospital
London, W21NY, United Kingdom
ROyal Manchester Children's Hospital
Manchester, M139WL, United Kingdom
Sheffield Children's Hospital
Sheffield, S102TH, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD, United Kingdom
Related Publications (2)
Scurlock AM, Fleischer DM, Toit GD, Arends NJT, Pongracic JA, Trujillo J, Turner P, Vogelberg C, Bee KJ, Green TD, Meney J, Bois T, Campbell DE, Sampson HA, Burks AW. Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Aug;135(2):203-210. doi: 10.1016/j.anai.2025.04.002. Epub 2025 Apr 7.
PMID: 40204253DERIVEDGreenhawt 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)
Results Point of Contact
- Title
- Pharis Mohideen, MD, Chief Medical Officer
- Organization
- DBV Technologies
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2017
First Posted
July 7, 2017
Study Start
July 31, 2017
Primary Completion
August 20, 2019
Study Completion
April 27, 2022
Last Updated
December 16, 2024
Results First Posted
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share