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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02916446
Other study ID # REALISE
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2016
Est. completion date October 7, 2020

Study information

Verified date February 2021
Source DBV Technologies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 393
Est. completion date October 7, 2020
Est. primary completion date September 22, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 11 Years
Eligibility 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 ß-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).

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Viaskin Peanut 250 mcg

Placebo


Locations

Country Name City State
Canada Alpha Medical Research Inc. Mississauga Ontario
Canada Centre Hospitalier Universitaire Sainte Justine Montréal Quebec
Canada Ottawa Allergy Asthma Research Institute Ottawa Ontario
Canada Centre De Recherche Applique Québec
Canada Gordon Sussman Clinical Research Inc. Toronto Ontario
Canada Children's and Women's Health Centre of Brisith Columbia Vancouver British Columbia
United States Children's Hospital Colorado Aurora Colorado
United States Johns Hopkins Hospital Baltimore Maryland
United States The Asthma and Allergy Center Bellevue Nebraska
United States Boston Childrens' Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States The University of North Carolina - Chapell Hill Chapel Hill North Carolina
United States National Allergy and Asthma Research Charleston South Carolina
United States Ann & Robert H. Lurie Children's Hospital of CHicago Chicago Illinois
United States Children's Medical Center of Dallas Dallas Texas
United States National Jewish Health Denver Colorado
United States Baylor College of Medicine - Texas Children's Hospital Houston Texas
United States Children's Mercy Hospital Kansas City Missouri
United States Arkansas Children's Hospital Little Rock Arkansas
United States Atlanta Allergy & Asthma Clinic Marietta Georgia
United States Allergy & Asthma Associates of Southern California Mission Viejo California
United States Mount Sinai Medical Center New York New York
United States Sneeze, Wheeze and Itch Associates,Clinical Research Normal Illinois
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Clinical Research Institute Plymouth Minnesota
United States Palos Verdes Medical Group Rolling Hills Estates California
United States STAAMP Research San Antonio Texas
United States Sylvana Research San Antonio Texas
United States Sarasota Clinical Research Sarasota Florida
United States ASTHMA, Inc. Clinical Research Seattle Washington
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
DBV Technologies

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in peanut-specific Immunoglobulins E (IgE) Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Other Change in peanut-specific Immunoglobulins G4 (IgG4) Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42
Primary Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through study completion, an average of 3 years
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