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Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children | Clinical Trials | Clareo Health

UNKNOWNPHASE3

Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children

Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut

NCT03013517•DBV Technologies

View on ClinicalTrials.gov

Summary

This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects who completed the PEPITES 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 (31)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

University of California, Rady Children's Hospital

San Diego, California, United States

Stanford University School of Medicine

Stanford, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

National Jewish Health

Denver, Colorado, United States

Ann & Robert Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Childrens' Hospital

Boston, Massachusetts, United States

Jaffe Food Allergy Institute

New York, New York, United States

Key Dates

Start Date

January 23, 2017

Primary Completion Date

November 23, 2019

Completion Date

March 1, 2023

Last Updated

December 2, 2020

Enrollment

300

ACTUAL participants

Conditions

Peanut Allergy

Interventions

Viaskin Peanut 250µg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children

Inclusion Criteria

Exclusion Criteria

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

Food Oral Immunotherapy for Peanut Allergy

Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants

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