Clinical trial NCT03013517: Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
Official title: Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peanut Allergy
Keywords: Allergy
food allergy
viaskin
peanut
epicutaneous
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2017-01-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: % 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
timeFrame: Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: San Diego
country: United States
facility: University of California, Rady Children's Hospital
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: Ann & Robert Lurie Children's Hospital of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Childrens' Hospital
state: Massachusetts
city: New York
country: United States
facility: Jaffe Food Allergy Institute
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina - Chapell Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: ASTHMA, Inc.
state: Washington
city: Brisbane
country: Australia
facility: Allergy Medical
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
city: Sydney
country: Australia
facility: Children's Hospital Westmead
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Mississauga
country: Canada
facility: Cheema Research Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Asthma Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Gordon Sussman Clinical Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: CHUM & CHU Sainte-Justine
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Appliquée en Allergie de Quebec
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: St.-Marien-Hospital
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Cork
country: Ireland
facility: Clinical Investigations Unit
city: Dublin
country: Ireland
facility: Our Lady's Children's Hospital
Study officials:
References: