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Viaskin Peanut 250µg

Phase 3

Peanut Allergy | Small molecule | Immunology |DBV Technologies S.A.|Trials Updated: Oct 8, 2026

Viaskin Peanut 250µg development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jan 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment693

FDA Designations

ACCELERATED_APPROVALPRIORITY_REVIEW

Viaskin Peanut 250µg clinical trials

Viaskin Peanut 250µg · 2 trials · 1 indication

Phase 3 2
NCT03013517Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in ChildrenPeanut Allergy
ACTIVE NOT_RECRUITING300 Analytics
NCT02916446Safety Study of Viaskin Peanut to Treat Peanut AllergyPeanut Allergy
COMPLETED393 Analytics
PHASE3ACTIVE NOT_RECRUITING
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
Peanut AllergyUnlock trial analytics
PHASE3COMPLETED
Safety Study of Viaskin Peanut to Treat Peanut Allergy
Peanut AllergyUnlock trial analytics

Study Endpoints

Primary Endpoints

% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE
Month 24
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
From Day 1 up to Month 6

An adverse event (AE) was any untoward medical occurrence that occurred in a participant administered IP, whether or not considered related to IP. A TEAE was defined as an AE that began or worsened in severity after at least 1 dose of IP had been administered.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Viaskin Peanut 250µgEXPERIMENTAL -
Viaskin Peanut 250 µgEXPERIMENTALViaskin Peanut 250 µg, daily administration
PlaceboPLACEBO_COMPARATORPlacebo patch, daily administration

Interventions

NameTypeDescription
Viaskin Peanut 250µgDRUGDBV712 250 µg, once daily
Viaskin Peanut 250 µgBIOLOGICAL -
PlaceboBIOLOGICAL -
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Eligibility Criteria

Age Range4 Years to 11 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Subjects who completed the PEPITES 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 intac...

Countries:United StatesAustraliaCanadaGermanyIreland
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