Open
Actively Recruiting
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
About
Brief Summary
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month treatment period.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
- Aged 4 through 7 years at Visit 1 (screening).
- Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
- Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.
- An ED of ≤100 mg peanut protein at screening DBPCFC.
Key Exclusion Criteria:
- Severe generalized dermatologic disease involving the application area (interscapular region)
- Uncontrolled persistent asthma.
- Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).
- Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
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Study Stats
Protocol No.
23-5045
Category
Pediatric and Prenatal Disorders
Principal Investigator
Contact
Location
- UCLA Westwood