Clinical trial NCT03211247: Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Official title: A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peanut Allergy
Keywords: EPIT
Epicutaneous
Immunotherapy
Viaskin
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2017-07-07
Enrollment: 414
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Detailed description: The study comprised of two parts:

* In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
* In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months

Eligibility criteria: Key Inclusion Criteria:

* Male or female from 1-3 years of age;
* Physician-diagnosed peanut allergy;
* Peanut-specific IgE level \> 0.7 kU/L;
* Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
* Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

* Uncontrolled asthma;
* History of severe anaphylaxis to peanut;
* Prior immunotherapy to any food or other immunotherapy;
* Generalized severe dermatologic disease;

Primary outcomes:
measure: Percentage of Treatment Responders at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
timeFrame: Month 12
measure: Change From Baseline in CRD of Peanut Protein to Month 12
timeFrame: Baseline (Day 1) and Month 12
measure: ED of Peanut Protein at Month 12 Using ANCOVA Model
timeFrame: Month 12
measure: Change From Baseline in ED of Peanut Protein to Month 12
timeFrame: Baseline (Day 1) and Month 12
measure: Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
timeFrame: Baseline (Day 1) and Month 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Health Science
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: University of California School of Medicine
state: California
city: San Diego
country: United States
facility: University of California, Rady Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
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: Washington
country: United States
facility: Children's national Health System
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of CHicago
state: Illinois
city: Chicago
country: United States
facility: The Universal of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children at Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Childrens' Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina - Chapell Hill
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
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: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
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: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: NWS
city: South Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
city: North Adelaide
country: Australia
facility: The Women's and children's hospital
state: South Australia
city: Parkville
country: Australia
facility: The Royal Children's Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: CHUM & CHU Sainte-Justine
state: Quebec
city: Lille
country: France
facility: CHRU Lille
city: Metz
country: France
facility: CHRU Metz-Thionville
city: Nice
country: France
facility: Hopitaux Pediatriques de Nice
city: Paris
country: France
facility: Hopital Necker
city: Vandoeuvre les nancy
country: France
facility: CHRU Nancy
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Marburg
country: Germany
facility: Universitatklinikum Giessen und Marburg
city: Cork
country: Ireland
facility: Cork University Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus MC Sophia Children's Hospital
city: London
country: United Kingdom
facility: Guy's and Saint Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: St.Mary's Hospital
city: Manchester
country: United Kingdom
facility: ROyal Manchester Children's Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
References: