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Clinical trial

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

ID
Name
EPOPEX (V712-305)
Description
Open-label, follow-up study for subjects who completed the EPITOPE study.
Trial arms
Trial start
2018-12-06
Estimated PCD
2023-06-01
Trial end
2025-05-01
Phase
Early phase I
Treatment
DBV712 250 mcg
DBV712 250 mcg, once daily
Arms:
DBV712 250mcg
Size
330
Primary endpoint
Proportion of subjects reaching an ED ≥1000 mg
12 months
Proportion of subjects reaching an ED ≥1000 mg
24 months
Proportion of subjects reaching an ED ≥1000 mg
36 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 330, 'type': 'ESTIMATED'}}
Updated at
2023-02-06

1 organization

1 product

1 indication

Organization
DBV Technologies
Product
DBV712
Indication
Peanut Allergy