Winnipeg - Manitoba Allergy Research Inc
Burlington - Halton Pediatric Allergy
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Last Update Posted: September 24, 2023
NCT05741476
DBV Technologies
Brief Summary:
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month treatment period.
Condition or Disease:
Allergy, Peanut
Intervention/Treatment:
Drug: DBV712Phase:
Phase 3
Ages Eligible for Study:
4 Years and 7 Years (Child)
Sexes Eligible for Study:
All
Key Inclusion Criteria:
Aged 4 through 7 years at Visit 1 (screening).
Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.
An ED of ≤100 mg peanut protein at screening DBPCFC.
Key Exclusion Criteria:
Severe generalized dermatologic disease involving the application area (interscapular region)
Uncontrolled persistent asthma.
Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).
Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
Terms and Conditions – ClinicalTrials.gov
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