Safety Study of Viaskin Peanut to Treat Peanut Allergy
- Conditions
- Peanut Allergy
- Registration Number
- NCT02916446
- Lead Sponsor
- DBV Technologies
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 393
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through study completion, an average of 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Allergy & Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States
Palos Verdes Medical Group
🇺🇸Rolling Hills Estates, California, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
Atlanta Allergy & Asthma Clinic
🇺🇸Marietta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of CHicago
🇺🇸Chicago, Illinois, United States
Sneeze, Wheeze and Itch Associates,Clinical Research
🇺🇸Normal, Illinois, United States
Scroll for more (22 remaining)Arkansas Children's Hospital🇺🇸Little Rock, Arkansas, United States