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.

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).

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Biological: Part A Viaskin Peanut 250 mcg; Biological: Part A Viaskin Peanut 100 mcg; Biological: Part A Placebo; Biological: Part B Viaskin Peanut 250 mcg; Biological: Part B Placebo

Detailed Description

The study comprised of two parts:

• In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
• In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months

• Study Type: Interventional
• Enrollment (Actual): 414
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • NWS
    • Randwick, NWS, Australia, 2031
      • Sydney Children's Hospital
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • The Children's Hospital at Westmead
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Queensland Children's Hospital
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • The Women's and Children's Hospital
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • The Royal Children's Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Perth Children's Hospital
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5H 3V4
      • British Columbia Children's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C4
      • CHUM & CHU Sainte-Justine
• France
  • Lille, France, 59037
    • CHRU Lille
  • Metz, France, 57085
    • CHRU Metz-Thionville
  • Nice, France, 06200
    • Hopitaux Pediatriques de Nice
  • Paris, France, 75015
    • Hopital Necker
  • Vandoeuvre les nancy, France, 54511
    • CHRU Nancy
• Germany
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Marburg, Germany, 35033
    • Universitatklinikum Giessen und Marburg
• Ireland
  • Cork, Ireland, T12YE02
    • Cork University Hospital
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Erasmus MC Sophia Children's Hospital
• United Kingdom
  • London, United Kingdom, SE17EH
    • Guy's and Saint Thomas' NHS Foundation Trust
  • London, United Kingdom, W21NY
    • St.Mary's Hospital
  • Manchester, United Kingdom, M139WL
    • Royal Manchester Children's Hospital
  • Sheffield, United Kingdom, S102TH
    • Sheffield Children's Hospital
  • Southampton, United Kingdom, SO166YD
    • University Hospital Southampton NHS Foundation Trust
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona Health Science
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 10833
      • University of California School of Medicine
    • San Diego, California, United States, 92123
      • University of California, Rady Children's Hospital
    • San Francisco, California, United States, 94158
      • University of California San Francisco
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Health System
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60637
      • The Universal of Chicago Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children at Indiana University
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Childrens' Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan Health System
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina - Chapell Hill
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15213
      • Children's Hospital of Pittsburgh
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Le Bonheur Children's Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center
    • Dallas, Texas, United States, 75235
      • Children's Medical Center of Dallas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Texas Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98115
      • ASTHMA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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;

Key Exclusion Criteria:

• Uncontrolled asthma;
• History of severe anaphylaxis to peanut;
• Prior immunotherapy to any food or other immunotherapy;
• Generalized severe dermatologic disease;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Viaskin Peanut 250 mcg	Biological: Part A Viaskin Peanut 250 mcg; Viaskin Peanut 250 mcg, once daily
Experimental: Part A Viaskin Peanut 100 mcg	Biological: Part A Viaskin Peanut 100 mcg; Viaskin Peanut 100 mcg, once daily
Placebo Comparator: Part A Placebo	Biological: Part A Placebo; Placebo patch, once daily
Experimental: Part B Viaskin Peanut 250 mcg	Biological: Part B Viaskin Peanut 250 mcg; Viaskin Peanut 250 mcg, once daily
Placebo Comparator: Part B Placebo	Biological: Part B Placebo; Placebo patch, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model	The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.	Month 12
Change From Baseline in CRD of Peanut Protein to Month 12	The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses.	Baseline (Day 1) and Month 12
ED of Peanut Protein at Month 12 Using ANCOVA Model	The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared using ANCOVA model.	Month 12
Change From Baseline in ED of Peanut Protein to Month 12	The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge.	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	The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms), with the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=" absent",1=" mild", 2=" moderate" or 3=" severe". For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. Subjective abdominal pain (when graded 2 or 3) was also considered for this analysis.	Baseline (Day 1) and Month 12

Other Outcome Measures

Outcome Measure	Time Frame
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)	Throughout the study during 12 months

Collaborators and Investigators

• Sponsor: DBV Technologies

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; EPIT; Epicutaneous; Viaskin
• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: EPITOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No