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

Recruiting Phase 3 Interventional Study
Allergy Peanut Allergy
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 – 3
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
480 (estimated)
Sponsor
DBV Technologies · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Key Inclusion 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…
Contacts

DBV Technologies

908-679-5200

clinicaltrials@dbv-technologies.com

CONTACT

DBV Technologies

908-679-5200

CONTACT