Peanut Allergy Clinical Trial
— REALISEVerified date | February 2021 |
Source | DBV Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
DBV Technologies |
United States, Canada,
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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