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Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Not Recruiting
Trial ID: NCT03211247
Purpose
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
Eligibility
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;
Intervention(s):
biological: Viaskin Peanut 250 mcg
biological: Viaskin Peanut 100 mcg
biological: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sayantani Sindher
650-724-0293