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

Status unconfirmed · Phase 3

Conditions studied: Peanut Allergy

In brief

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.

Key facts

Study ID

NCT03013517

Run by

DBV Technologies

People needed

300

Starts

2017-01-23

Expected to finish

2023-03-01

Last updated by the study team

2020-12-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Children's Medical Center of Dallas — Dallas, Texas, United States
• Baylor College of Medicine - Texas Children's Hospital — Houston, Texas, United States
• ASTHMA, Inc. — Seattle, Washington, 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, Canada
• Cheema Research Inc. — Mississauga, Ontario, Canada
• Ottawa Allergy Asthma Research Institute — Ottawa, Ontario, Canada
• Gordon Sussman Clinical Research Inc. — Toronto, Ontario, Canada
• CHUM & CHU Sainte-Justine — Montreal, Quebec, Canada
• 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
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.