Status:
COMPLETED
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
Lead Sponsor:
DBV Technologies
Conditions:
Peanut Allergy
Eligibility:
All Genders
2-5 years
Phase:
PHASE3
Brief Summary
Open-label, follow-up study for subjects who completed the EPITOPE study.
Eligibility Criteria
Inclusion
- completion of the EPITOPE study
Exclusion
- 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
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2025
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT03859700
Start Date
December 6 2018
End Date
May 13 2025
Last Update
June 6 2025
Active Locations (26)
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1
Banner University Medical Center Tucson
Tucson, Arizona, United States, 85724-5030
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
David Geffen School of Medicine at University of California Los Angeles
Los Angeles, California, United States, 90095
4
Rady Children's Hospital San Diego
San Diego, California, United States, 92123