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Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

NCT05741476 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-01-22

No results posted yet for this study

Summary

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.

Conditions

  • Allergy, Peanut

Interventions

DRUG

DBV712

DBV712 250 mcg epicutaneous system.

OTHER

Placebo

DBV712 matching placebo epicutaneous system.

DRUG

DBV712

DBV712 250 mcg epicutaneous system.

Sponsors & Collaborators

  • DBV Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2025-11-06
Completion
2029-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Ireland
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05741476 on ClinicalTrials.gov