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…