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

DBV Technologies

Status and phase: Completed; Phase 3

Conditions: Peanut Allergy

Treatments: Biological: DBV712 250 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03859700

EPOPEX (V712-305)

Details and patient eligibility

About

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

Enrollment: 304 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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304 participants in 1 patient group

DBV712 250mcg

Experimental group

Treatment:

Biological: DBV712 250 mcg