A Phase 3 interventional study of DBV712 250 mcg and Placebo in Allergy and Peanut Allergy, sponsored by DBV Technologies. Active, not recruiting at 91 sites in 8 countries. Open to participants aged 1 Year to 3 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by DBV Technologies · Phase 3, Interventional, and Treatment
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.
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.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 480 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →DBV Technologies is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Compared within Peanut Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.
Combination Product: DBV712 250 mcg
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.
Combination Product: Placebo
The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo).
Combination Product: DBV712 250 mcg
DBV712 250 mcg epicutaneous system.
Also known as: Viaskin® Peanut Patch
DBV712 matching placebo epicutaneous system.
DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Time frame: Through DBPC Treatment Period, 6 months
Concentration of peanut-specific IgE (kUA/L) at baseline and month 6.
Time frame: Month 6
Concentration of peanut-specific IgG4 (mg/L) at baseline and month 6.
Time frame: Month 6
DBPC Treatment Period: Change from baseline in peanut Skin Prick Test (SPT) mean wheal diameters
Time frame: Month 6
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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DBV Technologies