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
COMPLETED
Detailed Description
The study comprised of two parts: * In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B * In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months
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
Part A Viaskin Peanut 250 mcg
BIOLOGICAL
Part A Viaskin Peanut 100 mcg
BIOLOGICAL
Part A Placebo
BIOLOGICAL
Part B Viaskin Peanut 250 mcg
BIOLOGICAL
Part B Placebo
Phase
PHASE3
Gender
ALL
Min Age
1 Year
Max Age
3 Years
Download Date
2024-12-16
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: