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

Phase 3CompletedNCT03859700

DBV Technologies304 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

304

Conditions

Peanut Allergy

Interventions

DBV712 250 mcgBIOLOGICAL

DBV712 250 mcg, once daily

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (26)

Outcomes

Primary Outcomes

Proportion of subjects reaching an ED ≥1000 mg

Time frame: 12 months

Proportion of subjects reaching an ED ≥1000 mg

Time frame: 24 months

Proportion of subjects reaching an ED ≥1000 mg

Time frame: 36 months

Secondary Outcomes

Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)

Time frame: Throughout the study during 36 months

Data from ClinicalTrials.gov

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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 D.C., 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

...and 16 more locations