Summary

for people ages 1-3 (full criteria)
at San Diego, California and other locations
study started
estimated completion
Stephanie Leonard

Description

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).

Official Title

A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

Keywords

Peanut AllergyEPITEpicutaneousImmunotherapyViaskinPeanut HypersensitivityViaskin Peanut 250 mcgViaskin Peanut 100 mcg

Eligibility

For people ages 1-3

Key Inclusion Criteria:

  • Male or female from 1-3 years of age;
  • Physician-diagnosed peanut allergy;
  • Peanut-specific IgE level > 0.7 kU/L;
  • Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
  • Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

  • Uncontrolled asthma;
  • History of severe anaphylaxis to peanut;
  • Prior immunotherapy to any food or other immunotherapy;
  • Generalized severe dermatologic disease;

Locations

  • University of California, Rady Children's Hospitalnot yet accepting patients
    San DiegoCalifornia92123United States
  • University of California School of Medicineaccepting new patients
    Los AngelesCalifornia10833United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
DBV Technologies
ID
NCT03211247
Phase
Phase 3
Study Type
Interventional
Last Updated