Overview
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
Description
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.
Eligibility
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.