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

Primary Purpose

Peanut Allergy

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Viaskin Peanut 250 mcg
Viaskin Peanut 100 mcg
Placebo
Sponsored by
DBV Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring EPIT, Epicutaneous, Immunotherapy, Viaskin

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • University of Arizona Health Science
  • Arkansas Children's Hospital
  • University of California School of Medicine
  • University of California, Rady Children's Hospital
  • University of California San Francisco
  • Stanford University School of Medicine
  • Children's Hospital Colorado
  • Children's national Health System
  • Emory University
  • Ann & Robert H. Lurie Children's Hospital of CHicago
  • The Universal of Chicago Medical Center
  • Riley Hospital for Children at Indiana University
  • Johns Hopkins Hospital
  • Boston Childrens' Hospital
  • University of Michigan Health System
  • Mount Sinai Medical Center
  • University of Rochester
  • The University of North Carolina - Chapell Hill
  • Cleveland Clinic
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • Le Bonheur Children's Hospital
  • Vanderbilt University Medical Center
  • Dell Children's Medical Center
  • Children's Medical Center of Dallas
  • Baylor College of Medicine - Texas Children's Hospital
  • ASTHMA, Inc.
  • The Children's Hospital at Westmead
  • Sydney Children's Hospital
  • Queensland Children's Hospital
  • The Women's and children's hospital
  • The Royal Children's Hospital
  • Perth Children's Hospital
  • British Columbia Children's Hospital
  • Hospital for Sick Children
  • CHUM & CHU Sainte-Justine
  • CHRU Lille
  • CHRU Metz-Thionville
  • Hopitaux Pediatriques de Nice
  • Hopital Necker
  • CHRU Nancy
  • Universitatsklinikum Carl Gustav Carus
  • Universitatsklinikum Frankfurt
  • Universitatklinikum Giessen und Marburg
  • Cork University Hospital
  • Erasmus MC Sophia Children's Hospital
  • Guy's and Saint Thomas' NHS Foundation Trust
  • St.Mary's Hospital
  • ROyal Manchester Children's Hospital
  • Sheffield Children's Hospital
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Viaskin Peanut 250 mcg

Viaskin Peanut 100 mcg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Differences between the percentage of treatment responders in the selected active Viaskin Peanut group compared to the placebo group.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2017
Last Updated
April 23, 2021
Sponsor
DBV Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT03211247
Brief Title
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Acronym
EPITOPE
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DBV Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
EPIT, Epicutaneous, Immunotherapy, Viaskin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Viaskin Peanut 250 mcg
Arm Type
Experimental
Arm Title
Viaskin Peanut 100 mcg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Viaskin Peanut 250 mcg
Intervention Description
Viaskin Peanut 250 mcg, once daily
Intervention Type
Biological
Intervention Name(s)
Viaskin Peanut 100 mcg
Intervention Description
Viaskin Peanut 100 mcg, once daily
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo patch, once daily
Primary Outcome Measure Information:
Title
Differences between the percentage of treatment responders in the selected active Viaskin Peanut group compared to the placebo group.
Time Frame
Month 12
Other Pre-specified Outcome Measures:
Title
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Time Frame
Throughout the study during 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
University of Arizona Health Science
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
University of California School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
10833
Country
United States
Facility Name
University of California, Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's national Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of CHicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Universal of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Riley Hospital for Children at Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Boston Childrens' Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
The University of North Carolina - Chapell Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Dell Children's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine - Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
ASTHMA, Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
NWS
ZIP/Postal Code
2031
Country
Australia
Facility Name
Queensland Children's Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
The Women's and children's hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
The Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Perth Children's Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5H 3V4
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
CHUM & CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C4
Country
Canada
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU Metz-Thionville
City
Metz
ZIP/Postal Code
57085
Country
France
Facility Name
Hopitaux Pediatriques de Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHRU Nancy
City
Vandoeuvre les nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitatsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitatklinikum Giessen und Marburg
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
T12YE02
Country
Ireland
Facility Name
Erasmus MC Sophia Children's Hospital
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Guy's and Saint Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE17EH
Country
United Kingdom
Facility Name
St.Mary's Hospital
City
London
ZIP/Postal Code
W21NY
Country
United Kingdom
Facility Name
ROyal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M139WL
Country
United Kingdom
Facility Name
Sheffield Children's Hospital
City
Sheffield
ZIP/Postal Code
S102TH
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
ZIP/Postal Code
SO166YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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