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

  • Interventional
  • Recruiting
  • NCT03211247
Eligibility Details Visit Clinicaltrials.gov

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.

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).

Gender
All

Age Group
1 Year to 3 Years

Accepting Healthy Volunteers?
No

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;

At a Glance

National Government IDNCT03211247

IRB#IRB18-1687

Lead SponsorDBV Technologies

Lead PhysicianChristina Ciaccio

Collaborator(s)N/A

EligibilityAll
1 Year to 3 Years
Recruiting