Clinical trial NCT02916446: Safety Study of Viaskin Peanut to Treat Peanut Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peanut Allergy
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 393
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.


Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed peanut allergy;
* A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm;
* A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L;
* Subjects following a strict peanut-free diet.

Exclusion Criteria:

* Generalized dermatologic disease
* Spirometry forced expiratory volume in 1 second (FEV1) \<80% of the predicted value, or peak expiratory flow (PEF) \<80% of predicted value;
* Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy;
* Prior or concomitant history of any immunotherapy to any food allergy (for example EPIT, OIT, SLIT, or specific oral tolerance induction).

Primary outcomes:
measure: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
measure: Change in peanut-specific Immunoglobulins E (IgE)
timeFrame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
measure: Change in peanut-specific Immunoglobulins G4 (IgG4)
timeFrame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California
state: California
city: Rolling Hills Estates
country: United States
facility: Palos Verdes Medical Group
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: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Marietta
country: United States
facility: Atlanta Allergy & Asthma Clinic
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of CHicago
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze and Itch Associates,Clinical Research
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: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Bellevue
country: United States
facility: The Asthma and Allergy Center
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina - Chapell Hill
state: North Carolina
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: Charleston
country: United States
facility: National Allergy and Asthma Research
state: South Carolina
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: San Antonio
country: United States
facility: Sylvana Research
state: Texas
city: San Antonio
country: United States
facility: STAAMP Research
state: Texas
city: Seattle
country: United States
facility: ASTHMA, Inc. Clinical Research
state: Washington
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of Brisith Columbia
state: British Columbia
city: Mississauga
country: Canada
facility: Alpha Medical 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: Montréal
country: Canada
facility: Centre Hospitalier Universitaire Sainte Justine
state: Quebec
city: Québec
country: Canada
facility: Centre De Recherche Applique
Study officials:
References: