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.
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).
1 Year to 3 Years
Accepting Healthy Volunteers?
- 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;