Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children

Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03013517

Acronym

PEOPLE

Enrollment

300

Registered

2017-01-06

Start date

2017-01-23

Completion date

2023-03-31

Last updated

2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peanut Allergy

Keywords

Allergy, food allergy, viaskin, peanut, epicutaneous

Brief summary

This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.

Interventions

DRUGViaskin Peanut 250µg

DBV712 250 µg, once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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 intact zones to apply the Viaskin patches. * Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.

Design outcomes

Primary

Measure	Time frame
% 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

Countries

Australia, Canada, Germany, Ireland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026