Follow-up Study to Evaluate the Long-term Efficacy and Safety of Viaskin® Peanut

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002916-42-IE

Enrollment

255

Registered

2016-12-08

Start date

Unknown

Completion date

Unknown

Last updated

2022-01-17

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

Conditions

Peanut Allergy MedDRA version: 20.1 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 100000004870

Interventions

Product Name: Viaskin Peanut Pharmaceutical Form: Cutaneous patch INN or Proposed INN: Peanut Protein Extract Current Sponsor code: Peanut Protein Extract Concentration unit: % percent Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent from parent(s)/guardian(s) of the child and child’s assent for children =7 years or as per country-specific regulations or laws. - Subjects who completed the PEPITES study, with a mandatory, completed and documented DBPCFC at Month 12 (i.e. both Visit 10 and Visit 11 performed). Are the trial subjects under 18? yes Number of subjects for this age range: 255 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Subjects who developed a severe anaphylactic reaction during the PEPITES 12-Month DBPCFC (at V10 or V11) - Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To assess the clinical benefit of Viaskin® Peanut 250 µg after up to 36 months of EPIT to induce / maintain desensitization to peanut in peanut-allergic children. -To explore the clinical benefit of Viaskin®Peanut 250 µg after up to 5 years of EPIT to induce/maintain desensitization to peanut in peanut allergic children. - To assess the sustainability of unresponsiveness to peanut (eliciting dose [ED] =1,000 mg) after 2 months of treatment discontinuation - To evaluate the safety of long-term treatment with Viaskin® Peanut 250 µg in peanutallergic children.;Secondary Objective: To explore novel biomarkers that may be predictive of the clinical trial response;Primary end point(s): - The main endpoint for assessing peanut desensitization is the percentage of subjects reaching an Eliciting Dose (ED) = 1,000 mg after 3 years of active treatment overall in the VP250+VP250 group compared to the percentage after 1 year of active treatment (end of the PEPITES study). - Adverse Events and Treatment-emergent adverse events (TEAEs) by System Organ Class (SOC) and Preferred Terms (PTs);Timepoint(s) of evaluation of this end point: 3 years of active treatment	—

Measure

Time frame

Main Objective: - To assess the clinical benefit of Viaskin® Peanut 250 µg after up to 36 months of EPIT to induce / maintain desensitization to peanut in peanut-allergic children. -To explore the clinical benefit of Viaskin®Peanut 250 µg after up to 5 years of EPIT to induce/maintain desensitization to peanut in peanut allergic children. - To assess the sustainability of unresponsiveness to peanut (eliciting dose [ED] =1,000 mg) after 2 months of treatment discontinuation - To evaluate the safety of long-term treatment with Viaskin® Peanut 250 µg in peanutallergic children.;Secondary Objective: To explore novel biomarkers that may be predictive of the clinical trial response;Primary end point(s): - The main endpoint for assessing peanut desensitization is the percentage of subjects reaching an Eliciting Dose (ED) = 1,000 mg after 3 years of active treatment overall in the VP250+VP250 group compared to the percentage after 1 year of active treatment (end of the PEPITES study). - Adverse Events and Treatment-emergent adverse events (TEAEs) by System Organ Class (SOC) and Preferred Terms (PTs);Timepoint(s) of evaluation of this end point: 3 years of active treatment

—

Secondary

Measure	Time frame
Secondary end point(s): - The percentage of subjects reaching an ED =1,000 mg - The cumulative reactive dose (CRD) of peanut protein;Timepoint(s) of evaluation of this end point: 3, 4 or 5 years of active treatment and 2 months after treatment discontinuation	—

Countries

Australia, Canada, Germany, Ireland, United States

Contacts

Public ContactClinical Trials Information

DBV TECHNOLOGIES S.A.

ClinDev@dbv-technologies.com+33(0)155 42 78 78

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026