Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
- Conditions
- Peanut Allergy
- Interventions
- Biological: DBV712 250 mcg
- Registration Number
- NCT03859700
- Lead Sponsor
- DBV Technologies
- Brief Summary
Open-label, follow-up study for subjects who completed the EPITOPE study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 330
- completion of the EPITOPE study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DBV712 250mcg DBV712 250 mcg -
- Primary Outcome Measures
Name Time Method Proportion of subjects reaching an ED ≥1000 mg 36 months
- Secondary Outcome Measures
Name Time Method Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) Throughout the study during 36 months
Trial Locations
- Locations (26)
Banner University Medical Center Tucson
🇺🇸Tucson, Arizona, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
University of Rochester
🇺🇸Rochester, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Rady Children's Hospital San Diego
🇺🇸San Diego, California, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Boston Childrens' Hospital
🇺🇸Boston, Massachusetts, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, 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
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Children's National Health Center
🇺🇸Washington, District of Columbia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Allergy & Asthma Research Institute
🇺🇸Seattle, Washington, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
University of Michigan - Allergy Specialty Clinic and Food Allergy Clinic
🇺🇸Ann Arbor, Michigan, United States
The University of North Carolina - Chapell Hill
🇺🇸Chapel Hill, North Carolina, United States
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States