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Safety Study of Viaskin Peanut to Treat Peanut Allergy
Not Recruiting
Trial ID: NCT02916446
Purpose
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.
Stanford Investigator(s)
R. Sharon Chinthrajah
Associate Professor of Medicine (Sean Parker Center for Allergy and Asthma Research - Clinic) and of Pediatrics
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 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).
Intervention(s):
biological: Viaskin Peanut 250 mcg
biological: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sharon Chinthrajah, MD
6505217237