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Viaskin Peanut

Phase 3

Peanut Allergy | Monoclonal antibody | Other |DBV Technologies S.A.|Last Updated: Jun 18, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment1,285
FDA Designations
ACCELERATED_APPROVAL
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02916446Safety Study of Viaskin Peanut to Treat Peanut AllergyPHASE3 COMPLETED 393Oct 1, 2016Oct 7, 2020Feb 3, 202132 United States, Canada
NCT02636699Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut AllergyPHASE3 COMPLETED 500Dec 1, 2015Aug 18, 2017Jun 18, 202531 United States, Australia +3
NCT01955109Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and ChildrenPHASE2 COMPLETED 171Sep 1, 2013Sep 1, 2016Jun 30, 202222 United States, Canada +2
NCT01675882Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut AllergyPHASE2 COMPLETED 221Aug 1, 2012Jul 1, 2014Oct 27, 202124 United States, Canada +3
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Study Endpoints
Primary Endpoints
Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Through study completion, an average of 3 years
Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population
At Month 12

The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed in the overall population.

Percentage of Treatment Responders at Months 12 and 24
Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study

A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of active treatment for those who received placebo in the VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 24 months of active treatment for those who received placebo in the VIPES study. The percentage of responders at Month 12 and Month 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.

Percentage of Treatment Responders at Month 12; Analyzed in Overall Population
At Month 12

A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).

Secondary Endpoints
Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup
At Month 12
Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12
Baseline and Month 12
Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24
Month 24 (end of treatment) of the OLFUS-VIPES study
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Viaskin Peanut 250 mcgEXPERIMENTALViaskin Peanut 250 mcg, daily administration
PlaceboPLACEBO_COMPARATORPlacebo patch, daily administration
Viaskin Peanut 250mcgEXPERIMENTALOne Viaskin epicutaneous delivery system (patch) containing 250 µg of peanut protein applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months.
Viaskin Peanut 50 mcgEXPERIMENTAL -
Viaskin Peanut 100 mcgEXPERIMENTAL -
Viaskin PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Viaskin Peanut 250 mcgBIOLOGICAL -
PlaceboBIOLOGICAL -
Viaskin Peanut 250mcgBIOLOGICALPeanut extract cutaneous patch
Viaskin Peanut 50 mcgBIOLOGICALSubjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract
Viaskin Peanut 100 mcgBIOLOGICALSubjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract
Viaskin PlaceboBIOLOGICALSubjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation
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Eligibility Criteria
Age Range4 Years — 11 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Physician-diagnosed peanut allergy; * A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm; * A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L; * Subjects following a strict peanut-free diet. Exclusion Criteria: * Generalized dermatologic disease * Spirometry ...

Countries:United StatesCanadaAustraliaGermanyIrelandFranceNetherlandsPoland
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