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Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy

NCT02636699 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-06-18

Study results available
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Summary

The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT).

Conditions

Interventions

BIOLOGICAL

Viaskin Peanut 250mcg

Peanut extract cutaneous patch

BIOLOGICAL

Placebo

Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract

Sponsors & Collaborators

  • DBV Technologies

    lead INDUSTRY

Principal Investigators

  • David M Fleischer, MD · Children's Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-08-18
Completion
2017-08-18

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Ireland

Study Locations

More Related Trials

Entities

Drugs
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 NCT02636699 on ClinicalTrials.gov