Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
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).
Condition
- Peanut Allergy
Eligibility
- Eligible Ages
- Between 1 Year and 3 Years
- Eligible Genders
- 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;
Exclusion Criteria
- Uncontrolled asthma; - History of severe anaphylaxis to peanut; - Prior immunotherapy to any food or other immunotherapy; - Generalized severe dermatologic disease;
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A Viaskin Peanut 250 mcg |
|
|
|
Experimental Part A Viaskin Peanut 100 mcg |
|
|
|
Placebo Comparator Part A Placebo |
|
|
|
Experimental Part B Viaskin Peanut 250 mcg |
|
|
|
Placebo Comparator Part B Placebo |
|
More Details
- Status
- Completed
- Sponsor
- DBV Technologies
Study Contact
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