RECRUITING

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

Description

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.

Conditions

AllergyPeanut Allergy
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Related Conditions:

AllergyPeanut Allergy

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Allergy
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

Respiratory Medicine Research Institute, Ann Arbor, Michigan, United States, 48197

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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).
  • * 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.

Ages Eligible for Study

1 Year to 3 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

DBV Technologies,

Study Record Dates

2028-05