StudyFinder
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
RECRUITING
1 year to 3 years old
Key
Inclusion Criteria:
* Aged 1 through 3 years at Visit 1 (screening).
* Physician-diagnosed peanut allergy and following a strict peanut-free diet
* Peanut-specific IgE \> 0.7 kUA/L.
* A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
* An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
Key Exclusion Criteria:
* Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
* Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
* Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
* History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
* Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
* Uncontrolled persistent asthma.COMBINATION_PRODUCT: DBV712 250 mcg, COMBINATION_PRODUCT: Placebo
Allergy, Peanut Allergy
Peanut hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy, Safety Study
DBV Technologies - clinicaltrials@dbv-technologies.com
NCT07003919