Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Trial ID or NCT#
NCT03211247
Status
NOT RECRUITING
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.
Eligibility Criteria
Ages Eligible for Study: 1 Year to 3 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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;
Investigator(s)
Sayantani Sindher
Allergist,
Immunologist
Clinical Associate Professor, Medicine
Clinical Associate Professor, Pediatrics - Allergy and Clinical Immunology
Contact us to find out if this trial is right for you.
Contact
Sayantani Sindher
650-724-0293
View on ClinicalTrials.gov
