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 Allergy EPIT Epicutaneous Immunotherapy Viaskin Peanut Hypersensitivity Viaskin Peanut 250 mcg Viaskin 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 Hospital not yet accepting patients
    San Diego California 92123 United States
  • University of California School of Medicine accepting new patients
    Los Angeles California 10833 United States

Lead Scientist

  • Stephanie Leonard
    Associate Clinical Professor, Pediatrics. Authored (or co-authored) 28 research publications

Details

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