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DBV712 IHRP

Phase 1

Peanut Allergy | Small molecule | Other |DBV Technologies S.A.|Last Updated: Jul 26, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03352726A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic SubjectsPHASE1 COMPLETED 27 — — Nov 24, 2017Jun 29, 2018Jul 26, 20192 United States
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Study Endpoints
Primary Endpoints
Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)
1 day to 2 weeks
Secondary Endpoints
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Throughout the study (1 day to 2 weeks)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
DBV712 Solution for Skin Prick TestEXPERIMENTALDBV712 In-House Reference Skin Prick Test preparation
Interventions
NameTypeDescription
DBV712 IHRPDRUGDBV712 Solution for Skin Prick Test
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Eligibility Criteria
Age Range12 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites2

Main Inclusion Criteria: * Male or female subjects aged between 12-50 years * Physician-diagnosed peanut allergy * Subject currently following a strict peanut-free diet * Documented history of positive test to peanut-specific IgE (ImmunoCAP system) \>0.7 kU/L * Positive peanut SPT with a largest wh...

Countries:United States
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