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DBV712

Phase 3

Peanut Allergy | Monoclonal antibody | Other |DBV Technologies S.A.|Last Updated: Jun 6, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment304
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03859700Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young ChildrenPHASE3 COMPLETED 304 — — Dec 6, 2018May 13, 2025Jun 6, 202526 United States
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Study Endpoints
Primary Endpoints
Proportion of subjects reaching an ED ≥1000 mg
12 months
Secondary Endpoints
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Throughout the study during 36 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DBV712 250mcgEXPERIMENTAL -
Interventions
NameTypeDescription
DBV712 250 mcgBIOLOGICALDBV712 250 mcg, once daily
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Eligibility Criteria
Age Range2 Years — 5 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * completion of the EPITOPE study Exclusion Criteria: * Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to...

Countries:United States
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