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

NCT ID: NCT03013517

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peanut Allergy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Allergy food allergy viaskin peanut epicutaneous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Viaskin Peanut 250µg

Group Type EXPERIMENTAL

Viaskin Peanut 250µg

Intervention Type DRUG

DBV712 250 µg, once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Viaskin Peanut 250µg

DBV712 250 µg, once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

DBV Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

University of California, Rady Children's Hospital

San Diego, California, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

Ann & Robert Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Boston Childrens' Hospital

Boston, Massachusetts, United States

Site Status

Jaffe Food Allergy Institute

New York, New York, United States

Site Status

The University of North Carolina - Chapell Hill

Chapel Hill, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Children's Medical Center of Dallas

Dallas, Texas, United States

Site Status

Baylor College of Medicine - Texas Children's Hospital

Houston, Texas, United States

Site Status

ASTHMA, Inc.

Seattle, Washington, United States

Site Status

Allergy Medical

Brisbane, , Australia

Site Status

Princess Margaret Hospital for Children

Perth, , Australia

Site Status

Children's Hospital Westmead

Sydney, , Australia

Site Status

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status

Cheema Research Inc.

Mississauga, Ontario, Canada

Site Status

Ottawa Allergy Asthma Research Institute

Ottawa, Ontario, Canada

Site Status

Gordon Sussman Clinical Research Inc.

Toronto, Ontario, Canada

Site Status

CHUM & CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Centre de Recherche Appliquée en Allergie de Quebec

Québec, , Canada

Site Status

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

St.-Marien-Hospital

Bonn, , Germany

Site Status

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status

Clinical Investigations Unit

Cork, , Ireland

Site Status

Our Lady's Children's Hospital

Dublin, , Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Canada Germany Ireland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PEOPLE

Identifier Type: -

Identifier Source: org_study_id