Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-3
SponsorDBV Technologies
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- DBV712 250 mcg
- Placebo
Treatment groups
480 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov