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
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