Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (EPITOPE)

December 11, 2024 updated by: DBV Technologies

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
414

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Treatment Responders at Month 12
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
Time Frame: 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 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
Time Frame: Baseline (Day 1) and 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
Time Frame: 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. 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
Time Frame: Baseline (Day 1) and 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
Time Frame: Baseline (Day 1) and Month 12
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Time Frame: Throughout the study during 12 months
Throughout the study during 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DBV Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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