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 groupsLocations
91Australia
Westmead Childrens Hospital2145, WestmeadNew South Wales, Australia
Queensland Children's Hospital and Health Service4101, South BrisbaneQueensland, Australia
Royal Children's Hospital Melbourne3052, ParkvilleVictoria, Australia
Epworth Healthcare Richmond3121, RichmondVictoria, Australia
Sponsors and collaborators
DBV Technologies
Lead sponsor
Source ClinicalTrials.gov