A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy
DBV Technologies
Summary
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 crite…
Eligibility
- Age range
- 1–3 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Combination ProductDBV712 250 mcg
DBV712 250 mcg epicutaneous system.
- Combination ProductPlacebo
DBV712 matching placebo epicutaneous system.
Locations (90)
- AllerVie Clinical ResearchBirmingham, Alabama
- University of Alabama at Birmingham Pediatric Primary Care ClinicBirmingham, Alabama
- Modena Allergy & AsthmaScottsdale, Arizona
- University of Arizona Asthma and Airway Disease Research CenterTucson, Arizona
- Arkansas Children's HospitalLittle Rock, Arkansas
- Modena Allergy & AsthmaLa Jolla, California