Purpose

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).

Condition

Eligibility

Eligible Ages
Between 1 Year and 3 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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;

Exclusion Criteria

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Viaskin Peanut 250 mcg
  • Biological: Viaskin Peanut 250 mcg
    Viaskin Peanut 250 mcg, once daily
Experimental
Viaskin Peanut 100 mcg
  • Biological: Viaskin Peanut 100 mcg
    Viaskin Peanut 100 mcg, once daily
Placebo Comparator
Placebo
  • Biological: Placebo
    Placebo patch, once daily

Recruiting Locations

Children's National and nearby locations

Children's national Health System
Washington, District of Columbia 20010
Contact:
Hemant Sharma, MD
202-476-6080
HSharma@childrensnational.org

More Details

NCT ID
NCT03211247
Status
Recruiting
Sponsor
DBV Technologies

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.