Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

Study Status: Recruiting

This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE). The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks. For participation eligibility, please refer to eligibility criteria section. Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Sex: ALL
Minimum Age: 1 Year
Maximum Age: 3 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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.

Conditions

Allergy, Peanut Allergy

Intervention/Treatment

COMBINATION_PRODUCT : DBV712 250 mcg
COMBINATION_PRODUCT : Placebo

Sponsor

DBV Technologies

Phase

PHASE3