Summary

Eligibility
for people ages 1-3 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

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

You can join if…

Open to people ages 1-3

  • 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;

You CAN'T join if...

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

Locations

  • University of California San Francisco
    San Francisco California 94158 United States
  • Stanford University School of Medicine
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
DBV Technologies
ID
NCT03211247
Phase
Phase 3
Study Type
Interventional
Last Updated