Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DBV Technologies

Criteria

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.