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Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children (EPOPEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859700
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Brief Summary:
Open-label, follow-up study for subjects who completed the EPITOPE study.

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: DBV712 250 mcg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: DBV712 250mcg Biological: DBV712 250 mcg
DBV712 250 mcg, once daily




Primary Outcome Measures :
  1. Proportion of subjects reaching an ED ≥1000 mg [ Time Frame: 12 months ]
  2. Proportion of subjects reaching an ED ≥1000 mg [ Time Frame: 24 months ]
  3. Proportion of subjects reaching an ED ≥1000 mg [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) [ Time Frame: Throughout the study during 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859700


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston Childrens' Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
DBV Technologies
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Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT03859700    
Other Study ID Numbers: EPOPEX (V712-305)
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DBV Technologies:
EPIT
Epicutaneous
Immunotherapy
Viaskin
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases