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Clinical Trials in Ireland / NCT03013517
Active, not recruiting Phase 3

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

NCT03013517 · tracked via the Priya Life Science Ireland tracker
Sponsor
DBV Technologies
Phase
Phase 3
Started
2017-01-23
Last updated
2020-12-02

Condition(s) studied

Peanut Allergy

Investigational drug(s) / intervention(s)

Viaskin Peanut 250µg

Viaskin Peanut 250µg: DBV712 250 µg, once daily

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • % 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

Trial sites (31)

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

More DBV Technologies trials in Ireland

Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) Active, not recruiting
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age Active, not recruiting

Other trials for the same condition

Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03013517 on ClinicalTrials.gov ↗ ← All trials in Ireland