Open
Actively Recruiting
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
About
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 double-blind, placebo-controlled (DBPC) Treatment Period.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria:
- Signed ICF by the participant's parent(s)/caregiver(s). This consent should be signed after completion of the procedures in the randomized, DBPC Treatment Period, and before any procedure in Open-label Extension Period begins.
- Participants who perform the peanut DBPCFC at the end of Month 12 and have ≥80% compliance with investigational medicinal product (IMP).
- Parent(s)/caregiver(s) and participants willing to comply with all study requirements during the participant's participation in the study.
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.
Participants may not enter the Open-label Extension Period if they meet any of the following exclusion criteria:
- Participants who develop a severe anaphylactic reaction during the DBPCFC at the end of Month 12 with the event requiring tracheal intubation or leading to a cardiac arrest and/or to coma. Participants with other reported cases of severe anaphylaxis will be considered eligible to participate in the Open-label Extension Period, at the judgement of the Investigator.
- Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures.
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Study Stats
Protocol No.
23-5045
Category
Pediatric and Prenatal Disorders
Principal Investigator
Contact
Location
- UCLA Westwood