NCT05741476

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

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: DBV Technologies · Industry
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is consisting of a 4-week Screening Period, 12-month DBPC Treatment Period and an open-label extension of either 24 or 36-months duration so that each participant may have the opportunity to receive DBV712 for a total duration of 36 months. Following 36 months of treatment with DBV712 250 mcg, sustained unresponsiveness (SU) will be evaluated by subsequent open food challenge(s) \[FC(s)\] at 2-, 4-, and 6-months off treatment. Maximum participant participation will be either approximately 44 or 56 months, depending on the participant's randomized treatment assignment. During the 4-week Screening Period, participants are required to meet 2 sequential screening parameters to determine eligibility prior to randomization: * Assessment of peanut skin prick test (SPT) and serum peanut immunoglobulin-E (IgE) * Peanut double-blind placebo-controlled food challenge (DBPCFC) to confirm peanut allergy and establish an entry peanut eliciting dose (ED). Participants with a peanut protein ED less than or equal to (≤) 100 milligram (mg) will be eligible for randomization. The starting dose of the eligibility peanut DBPCFC will be 1 mg peanut protein and will escalate up to a highest single dose of 100 mg peanut protein (cumulative 144 mg) via the following schedule: 1, 3, 10, 30, 100 mg. Participants who react, with an eliciting dose (ED) (with dose-limiting symptoms) at or below the dose of 100 mg peanut protein will be considered eligible. Randomization of eligible participants will occur in a 2:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Conditions

• Allergy, Peanut

Interventions

Type	Name	Description
DRUG	DBV712	DBV712 250 mcg epicutaneous system.
OTHER	Placebo	DBV712 matching placebo epicutaneous system.
DRUG	DBV712	DBV712 250 mcg epicutaneous system.

Timeline

• Start date: 2023-02-21
• Primary completion: 2025-11-06
• Completion: 2029-10-01
• First posted: 2023-02-23
• Last updated: 2026-01-22

Locations

87 sites across 9 countries: United States, Australia, Canada, France, Germany, Ireland, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study