MedTrace Logo

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

NCT03211247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2024-12-16

Study results available
· View outcomes & findings →

Summary

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Conditions

Interventions

BIOLOGICAL

Part A Viaskin Peanut 250 mcg

Viaskin Peanut 250 mcg, once daily

BIOLOGICAL

Part A Viaskin Peanut 100 mcg

Viaskin Peanut 100 mcg, once daily

BIOLOGICAL

Part A Placebo

Placebo patch, once daily

BIOLOGICAL

Part B Viaskin Peanut 250 mcg

Viaskin Peanut 250 mcg, once daily

BIOLOGICAL

Part B Placebo

Placebo patch, once daily

Sponsors & Collaborators

  • DBV Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2019-08-20
Completion
2022-04-27
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Diseases

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 NCT03211247 on ClinicalTrials.gov