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NCT03013517 Clinical Trial

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

Peanut Allergy Clinical Trial

— PEOPLE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03013517
Other study ID # PEOPLE
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 23, 2017
Est. completion date March 2023

Study information
Verified date December 2020
Source DBV Technologies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date March 2023
Est. primary completion date November 23, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Viaskin Peanut 250µg
DBV712 250 µg, once daily

Locations
Country Name City State
Australia Allergy Medical Brisbane
Australia Princess Margaret Hospital for Children Perth
Australia Children's Hospital Westmead Sydney
Canada Cheema Research Inc. Mississauga Ontario
Canada CHUM & CHU Sainte-Justine Montreal Quebec
Canada Ottawa Allergy Asthma Research Institute Ottawa Ontario
Canada Centre de Recherche Appliquée en Allergie de Quebec Quebec
Canada Gordon Sussman Clinical Research Inc. Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Germany Charité Universitätsmedizin Berlin Berlin
Germany St.-Marien-Hospital Bonn
Germany Universitätsklinikum Erlangen Erlangen
Ireland Clinical Investigations Unit Cork
Ireland Our Lady's Children's Hospital Dublin
United States Children's Hospital Colorado Aurora Colorado
United States Johns Hopkins Hospital Baltimore Maryland
United States Boston Childrens' Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States The University of North Carolina - Chapell Hill Chapel Hill North Carolina
United States Ann & Robert Lurie Children's Hospital of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Children's Medical Center of Dallas Dallas Texas
United States National Jewish Health Denver Colorado
United States Baylor College of Medicine - Texas Children's Hospital Houston Texas
United States Arkansas Children's Hospital Little Rock Arkansas
United States Jaffe Food Allergy Institute New York New York
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States University of California, Rady Children's Hospital San Diego California
United States ASTHMA, Inc. Seattle Washington
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
DBV Technologies

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary % of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) = 1,000 mg after 24 months of additional treatment in PEOPLE Month 24
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