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

Phase 3

Completed

• 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

Study Timeline

• Study Start: 2018-12-06
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Primary Completion: 2025-05-13
• Study Completion: 2025-05-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

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

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, 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

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