Summary
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).
Conditions
Peanut Allergy
Recruitment Status
Active, not recruiting
Eligibility Criteria
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
Intervention Type
Intervention Name
Biological
Viaskin Peanut 250 mcg
Biological
Viaskin Peanut 100 mcg
Biological
Placebo
Phase
Phase 3
Gender
All
Min Age
1 Year
Max Age
3 Years
Download Date
April 26, 2021
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: