Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age (VITESSE)
Allergy, Peanut
About this trial
This is an interventional treatment trial for Allergy, Peanut focused on measuring Peanut Hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy
Eligibility Criteria
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.
Sites / Locations
- DBV Investigative SiteRecruiting
- DBV Investigative Site
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- DBV Investigative siteRecruiting
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- DBV Investigative Site
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- DBV Investigative SiteRecruiting
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- DBV Investigative SiteRecruiting
- DBV Investigative Site
- DBV Investigative Site
- DBV Investigative Site
- DBV Investigative Site
- DBV Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
DBV712 250 mcg
Placebo
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).