Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

a study on Allergy Peanut Allergy Immunotherapy

Summary

Eligibility
for people ages 1-3 (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.

Official Title

A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy

Details

This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE).

The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks.

For participation eligibility, please refer to eligibility criteria section.

Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Keywords

Allergy, Peanut Allergy, Peanut hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Food Allergy, Nut and Peanut Allergy, Safety Study, Hypersensitivity, DBV712 250 mcg

Eligibility

You can join if…

Open to people ages 1-3

  • Aged 1 through 3 years at Visit 1 (screening).
  • Physician-diagnosed peanut allergy and following a strict peanut-free diet
  • Peanut-specific IgE > 0.7 kUA/L.
  • A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
  • An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).

You CAN'T join if...

  • Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
  • Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
  • Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
  • History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
  • Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
  • Uncontrolled persistent asthma.

Locations

  • UCLA Health Westwood Pediatrics accepting new patients
    Los Angeles California 90024 United States
  • Modena Allergy & Asthma accepting new patients
    La Jolla California 92037 United States
  • Allergy & Asthma Medical Group and Research Center accepting new patients
    San Diego California 92123 United States
  • Rady Children's Hospital - San Diego accepting new patients
    San Diego California 92123 United States
  • Children's Hospital of Los Angeles not yet accepting patients
    Los Angeles California 90027 United States
  • Allergy & Asthma Associates of Southern California accepting new patients
    Mission Viejo California 93691 United States
  • Modena Allergy and Asthma not yet accepting patients
    Long Beach California 90808 United States
  • Lucile Packard Children's Hospital Stanford accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
DBV Technologies
ID
NCT07003919
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 480 study participants
Last Updated
Contact us about this trial