Loading clinical trials...

Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children

NCT03859700•DBV Technologies

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

2 - 5 years

Sex

ALL

Healthy Volunteers

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

Locations (26)

Banner University Medical Center Tucson

Tucson, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

David Geffen School of Medicine at University of California Los Angeles

Los Angeles, California, United States

Rady Children's Hospital San Diego

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Stanford University School of Medicine

Stanford, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Health Center

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

December 6, 2018

Primary Completion Date

May 13, 2025

Completion Date

May 13, 2025

Last Updated

June 6, 2025

Enrollment

304

ACTUAL participants

Conditions

Peanut Allergy

Interventions

DBV712 250 mcg

BIOLOGICAL

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

NCT03835767

Milk and/or Peanut Allergy

View study

ENROLLING_BY_INVITATIONPHASE2

Food Oral Immunotherapy for Peanut Allergy

NCT04222491

Peanut Allergy

View study

ACTIVE_NOT_RECRUITINGNA

Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

NCT04511494

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

Food Oral Immunotherapy for Peanut Allergy

Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants

Immune Basis and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy