Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
PEOPLE
Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
1 other identifier
interventional
300
5 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2017
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedStudy Start
First participant enrolled
January 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedDecember 2, 2020
December 1, 2020
2.8 years
January 2, 2017
December 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% 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
Study Arms (1)
Viaskin Peanut 250µg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subjects who completed the PEPITES study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DBV Technologieslead
Study Sites (31)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
University of California, Rady Children's Hospital
San Diego, California, 92123, United States
Stanford University School of Medicine
Stanford, California, 94304, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Childrens' Hospital
Boston, Massachusetts, 02115, United States
Jaffe Food Allergy Institute
New York, New York, 10029, United States
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Children's Medical Center of Dallas
Dallas, Texas, 75390-9105, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030, United States
ASTHMA, Inc.
Seattle, Washington, 98115, United States
Allergy Medical
Brisbane, Australia
Princess Margaret Hospital for Children
Perth, Australia
Children's Hospital Westmead
Sydney, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, V5H 3V4, Canada
Cheema Research Inc.
Mississauga, Ontario, L5A 3V4, Canada
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, K1G 6C6, Canada
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, M4V 1R2, Canada
CHUM & CHU Sainte-Justine
Montreal, Quebec, H3T 1C4, Canada
Centre de Recherche Appliquée en Allergie de Quebec
Québec, QC G1V4M6, Canada
Charité Universitätsmedizin Berlin
Berlin, D13353, Germany
St.-Marien-Hospital
Bonn, D-53115, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Clinical Investigations Unit
Cork, Ireland
Our Lady's Children's Hospital
Dublin, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 2, 2017
First Posted
January 6, 2017
Study Start
January 23, 2017
Primary Completion
November 23, 2019
Study Completion
March 1, 2023
Last Updated
December 2, 2020
Record last verified: 2020-12