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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Allergy, Peanut
• Intervention / Treatment: Drug: DBV712; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5006
    • DBV Investigative Site
  • Nedlands, Australia, 6009
    • DBV Investigative Site
  • Parkville, Australia, 3052
    • DBV Investigative Site
  • Richmond, Australia, 3121
    • DBV Investigative Site
  • South Brisbane, Australia, 4101
    • DBV Investigative Site
  • Westmead, Australia, 2145
    • DBV Investigative Site
• Canada
  • Hamilton, Canada, L8SIG5
    • DBV Investigative Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • DBV Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3J 0S9
      • DBV Investigative Site
  • Ontario
    • Burlington, Ontario, Canada, L7L6W6
      • DBV Investigative Site
    • North York, Ontario, Canada, M3B3S6
      • DBV Investigative Site
    • Ottawa, Ontario, Canada, M5G 1X8
      • DBV Investigative Site
    • Toronto, Ontario, Canada, K1H1E4
      • DBV Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • DBV Investigative Site
    • Montreal, Quebec, Canada, H4A3J1
      • DBV Investigative Site
    • Québec, Quebec, Canada, G1v4W2
      • DBV Investigative Site
• France
  • Angers, France, 49933
    • DBV Investigative Site
  • Brest, France, 29609
    • DBV Investigative Site
  • Bron, France, 69500
    • DBV Investigative Site
  • Nice, France, 06200
    • DBV Investigative Site
  • Strasbourg, France, 67091
    • DBV Investigative Site
  • Vandœuvre-lès-Nancy, France, 54511
    • DBV Investigative Site
• Germany
  • Düsseldorf, Germany, 40217
    • DBV Investigative Site
  • Frankfurt, Germany, 60590
    • DBV Investigative Site
  • Ulm, Germany, 89075
    • DBV Investigative Site
• Ireland
  • Cork, Ireland, T12 DC4A
    • DBV Investigative Site
  • Dublin, Ireland, D12N512
    • DBV Investigative Site
• Netherlands
  • Rotterdam, Netherlands, 3015 CN
    • DBV Investigative Site
  • Utrecht, Netherlands, 3584 EA
    • DBV Investigative Site
• Spain
  • Madrid, Spain, 28009
    • DBV Investigative Site
  • Madrid, Spain, 28034
    • DBV Investigative Site
  • Málaga, Spain, CP 29011
    • DBV Investigative Site
• United Kingdom
  • London, United Kingdom, SE1 7ETH
    • DBV Investigative Site
  • London, United Kingdom, W2 1NY
    • DBV Investigative Site
  • Manchester, United Kingdom, M13 9WL
    • DBV Investigative Site
  • Sheffield, United Kingdom, S10 2TH
    • DBV Investigative Site
  • Southampton, United Kingdom, SO16 6YD
    • DBV Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • DBV Investigative Site
  • Arizona
    • Tucson, Arizona, United States, 85724
      • DBV Investigative Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • DBV Investigative Site
  • California
    • Los Angeles, California, United States, 90027
      • DBV Investigative Site
    • Los Angeles, California, United States, 90095
      • DBV Investigative Site
    • Mission Viejo, California, United States, 92691
      • DBV Investigative Site
    • San Diego, California, United States, 92123
      • DBV Investigative Site
    • San Francisco, California, United States, 94158
      • DBV Investigative Site
    • San Jose, California, United States, 95117
      • DBV Investigative Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • DBV Investigative Site
    • Colorado Springs, Colorado, United States, 80907
      • DBV Investigative Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • DBV Investigative Site
  • Florida
    • Hollywood, Florida, United States, 33021
      • DBV Investigative Site
    • Miami, Florida, United States, 33136
      • DBV Investigative Site
    • St. Petersburg, Florida, United States, 33701
      • DBV Investigative Site
    • Tampa, Florida, United States, 33613
      • DBV Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • DBV Investigative Site
    • Marietta, Georgia, United States, 30060
      • DBV Investigative Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DBV Investigative Site
    • Normal, Illinois, United States, 61761
      • DBV Investigative Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • DBV Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • DBV Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • DBV Investigative Site
    • Chevy Chase, Maryland, United States, 20815
      • DBV Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • DBV Investigative Site
    • Boston, Massachusetts, United States, 02115
      • DBV Investigative Site
    • Taunton, Massachusetts, United States, 02780
      • DBV Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • DBV Investigative Site
    • Ypsilanti, Michigan, United States, 48197
      • DBV Investigative Site
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • DBV Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • DBV Investigative Site
  • New York
    • Great Neck, New York, United States, 11021
      • DBV Investigative Site
    • New York, New York, United States, 10016
      • DBV Investigative Site
    • New York, New York, United States, 10029
      • DBV Investigative Site
    • Rochester, New York, United States, 14642
      • DBV Investigative Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • DBV Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • DBV Investigative Site
    • Cleveland, Ohio, United States, 44106
      • DBV Investigative Site
    • Cleveland, Ohio, United States, 44195
      • DBV Investigative Site
    • Columbus, Ohio, United States, 43205
      • DBV Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • DBV Investigative Site
    • Pittsburgh, Pennsylvania, United States, 15224
      • DBV Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • DBV Investigative Site
    • Nashville, Tennessee, United States, 37232
      • DBV Investigative Site
  • Texas
    • Austin, Texas, United States, 78723
      • DBV Investigative Site
    • Dallas, Texas, United States, 75235
      • DBV Investigative Site
    • Houston, Texas, United States, 77030
      • DBV Investigative Site
  • Washington
    • Seattle, Washington, United States, 98115
      • DBV Investigative Site
    • Seattle, Washington, United States, 98101
      • DBV Investigative Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • DBV Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DBPC Treatment Period: DBV712 250 mcg; Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).	Drug: DBV712; DBV712 250 mcg epicutaneous system.; Other Names: ViaskinTM Peanut
Placebo Comparator: DBPC Treatment Period: Placebo; Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).	Other: Placebo; DBV712 matching placebo epicutaneous system.
Experimental: Open Label Extension Period: DBV712 250 mcg; Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 2 additional years if they were randomized DBV712 250 mcg or for 3 years if they were randomized placebo. After 12 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 24), participants will undergo a peanut DBPCFC according to the following schedule: 3, 10, 30, 100, 300, 600, 1000, and 2000 mg (4043 mg cumulative dose). Participants who were randomized to placebo will also undergo an additional peanut DBPCFC after 24 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 36).	Drug: DBV712; DBV712 250 mcg epicutaneous system.; Other Names: ViaskinTM Peanut

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group	A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was > 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 250 mcg group compared to the placebo group after 12 months of treatment in the target population will be reported.	At Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DBPC Treatment Period: Cumulative Reactive Dose (CRD) of Peanut Protein	The Peanut Protein CRD is defined as the sum of all peanut protein doses taken by the participant during the DBPCFC (including the ED and any partial dose given before the reaction).	At Month 12
DBPC Treatment Period: Eliciting Dose (ED) of Peanut Protein		At Month 12
DBPC Treatment Period: Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12		At Month 12
DBPC Treatment Period: Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge	The maximum severity of allergic reaction will be assessed according to Consortium of Food Allergy Research (CoFAR) Grading Scale Version 3.0. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction.	Baseline up to Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)	An AE: any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAEs were defined as AEs that developed or worsened or became serious during on- treatment period. A serious TEAE: any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. AESI defined as: Local AESIs- severe local site reactions; systemic AESIs systemic allergic reactions, including those leading to epinephrine use, whatever the causal relationship to IP; AEs leading to epinephrine or inhaled or systemic corticosteroid use irrespective of the causal relationship to IP. TEAE's will include physical examination, vital signs, AEs leading to topical corticosteroid use, assessment of pain.	Screening up to 56 months.
Number of Participants With Systemic Allergic Reactions	Number of participants with systemic allergic reactions will be reported.	Screening up to 56 months.
Total Score for Scoring Atopic Dermatitis (SCORAD)	SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).	Screening up to 56 months.

Collaborators and Investigators

• Sponsor: DBV Technologies

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): November 6, 2025
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Peanut Allergy; Food Allergy; Epicutaneous Immunotherapy (EPIT); Epicutaneous; Viaskin; Food Hypersensitivity; Peanut Hypersensitivity; Nut and Peanut Hypersensitivity; Nut and Peanut Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: V712-306 (VITESSE); EU CTIS (Other Identifier: 2022-502110-85-00)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No