Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age


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Trial ID: NCT03211247


The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Official Title

A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

Stanford Investigator(s)

Sayantani Sindher

Clinical Associate Professor, Medicine Clinical Associate Professor, Pediatrics - Allergy and Clinical Immunology


Key Inclusion Criteria:

   - Male or female from 1-3 years of age;

   - Physician-diagnosed peanut allergy;

   - Peanut-specific IgE level > 0.7 kU/L;

   - Positive peanut SPT with a largest wheal diameter ≥ 6 mm;

   - Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

   - Uncontrolled asthma;

   - History of severe anaphylaxis to peanut;

   - Prior immunotherapy to any food or other immunotherapy;

   - Generalized severe dermatologic disease;


biological: Viaskin Peanut 250 mcg

biological: Viaskin Peanut 100 mcg

biological: Placebo


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sayantani Sindher