Back to resultsFollow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children (EPOPEX)
Primary Purpose
Peanut Allergy
Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DBV712 250 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring EPIT, Epicutaneous, Immunotherapy, Viaskin
Eligibility Criteria
Inclusion Criteria:
- completion of the EPITOPE study
Exclusion Criteria:
- 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
Sites / Locations
- Banner University Medical Center Tucson
- Arkansas Children's Hospital
- David Geffen School of Medicine at University of California Los Angeles
- Rady Children's Hospital San Diego
- University of California San Francisco
- Stanford University School of Medicine
- Children's Hospital Colorado
- Children's National Health Center
- Children's Healthcare of Atlanta
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Comer Children's Hospital
- Riley Hospital for Children
- Johns Hopkins Hospital
- Boston Childrens' Hospital
- University of Michigan - Allergy Specialty Clinic and Food Allergy Clinic
- Mount Sinai Medical Center
- University of Rochester
- The University of North Carolina - Chapell Hill
- Children's Hospital of Philadelphia
- UPMC Children's Hospital of Pittsburgh
- Le Bonheur Children's Hospital
- Vanderbilt University Medical Center
- Dell Children's Medical Center of Central Texas
- Children's Medical Center Dallas
- Baylor College of Medicine
- Seattle Allergy & Asthma Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DBV712 250mcg
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects reaching an ED ≥1000 mg
Proportion of subjects reaching an ED ≥1000 mg
Proportion of subjects reaching an ED ≥1000 mg
Secondary Outcome Measures
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03859700
Brief Title
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
Acronym
EPOPEX
Official Title
EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
May 2025 (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
Open-label, follow-up study for subjects who completed the EPITOPE study.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DBV712 250mcg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
DBV712 250 mcg
Intervention Description
DBV712 250 mcg, once daily
Primary Outcome Measure Information:
Title
Proportion of subjects reaching an ED ≥1000 mg
Time Frame
12 months
Title
Proportion of subjects reaching an ED ≥1000 mg
Time Frame
24 months
Title
Proportion of subjects reaching an ED ≥1000 mg
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Time Frame
Throughout the study during 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
completion of the EPITOPE study
Exclusion Criteria:
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
Facility Information:
Facility Name
Banner University Medical Center Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5030
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
David Geffen School of Medicine at University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Rady Children's Hospital San Diego
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 Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's Healthcare of Atlanta
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
Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Riley Hospital for Children
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 - Allergy Specialty Clinic and Food Allergy Clinic
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
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
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
37204
Country
United States
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Allergy & Asthma Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
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