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

NCT05741476 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: V712-306 (VITESSE)EU CTIS
• Study Type: interventional
• Target: 600
• Locations: 9 countries
• Sites: 87

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.

Conditions

Allergy, Peanut

Keywords

Peanut Hypersensitivity; Epicutaneous Immunotherapy (EPIT); Epicutaneous; Immunotherapy; Viaskin; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Peanut Allergy; Food Allergy; Nut and Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• DBPC Treatment Period: Cumulative Reactive Dose (CRD) of Peanut Protein

  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

  Baseline up to Month 12

Other Outcomes (3)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)

  Screening up to 56 months.

• Number of Participants With Systemic Allergic Reactions

  Screening up to 56 months.

• Total Score for Scoring Atopic Dermatitis (SCORAD)

  Screening up to 56 months.

Study Arms (3)

DBPC Treatment Period: DBV712 250 mcg

EXPERIMENTAL

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

DBPC Treatment Period: Placebo

PLACEBO COMPARATOR

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

Open Label Extension Period: DBV712 250 mcg

EXPERIMENTAL

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

Interventions

Placebo OTHER

DBV712 matching placebo epicutaneous system.

DBPC Treatment Period: Placebo

DBV712 DRUG

DBV712 250 mcg epicutaneous system.

Also known as: ViaskinTM Peanut

DBPC Treatment Period: DBV712 250 mcg

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• DBV Technologies: lead

Study Sites (87)

DBV Investigative Site

Birmingham, Alabama, 35233, United States

Location

DBV Investigative Site

Tucson, Arizona, 85724, United States

Location

DBV Investigative Site

Little Rock, Arkansas, 72202, United States

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DBV Investigative Site

Los Angeles, California, 90027, United States

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DBV Investigative Site

Los Angeles, California, 90095, United States

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DBV Investigative site

Mission Viejo, California, 92691, United States

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DBV Investigative Site

San Diego, California, 92123, United States

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DBV Investigative Site

San Francisco, California, 94158, United States

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DBV Investigative Site

San Jose, California, 95117, United States

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DBV Investigative Site

Aurora, Colorado, 80045, United States

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DBV Investigative Site

Colorado Springs, Colorado, 80907, United States

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DBV Investigative Site

Washington D.C., District of Columbia, 20010, United States

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DBV Investigative Site

Hollywood, Florida, 33021, United States

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DBV Investigative Site

Miami, Florida, 33136, United States

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DBV Investigative Site

St. Petersburg, Florida, 33701, United States

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DBV Investigative Site

Tampa, Florida, 33613, United States

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DBV Investigative site

Atlanta, Georgia, 30329, United States

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DBV Investigative Site

Marietta, Georgia, 30060, United States

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DBV Investigative Site

Chicago, Illinois, 60611, United States

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DBV Investigative Site

Normal, Illinois, 61761, United States

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DBV Investigative Site

Indianapolis, Indiana, 46202, United States

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DBV Investigative Site

Louisville, Kentucky, 40215, United States

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DBV Investigative Site

Baltimore, Maryland, 21287, United States

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DBV Investigative Site

Chevy Chase, Maryland, 20815, United States

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DBV Investigative Site

Boston, Massachusetts, 02114, United States

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DBV Investigative Site

Boston, Massachusetts, 02115, United States

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DBV Investigative Site

Taunton, Massachusetts, 02780, United States

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DBV Investigative Site

Ann Arbor, Michigan, 48106, United States

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DBV Investigative Site

Ypsilanti, Michigan, 48197, United States

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DBV Investigative Site

Maplewood, Minnesota, 55109, United States

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DBV Investigative Site

Kansas City, Missouri, 64108, United States

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DBV Investigative Site

Great Neck, New York, 11021, United States

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DBV Investigative Site

New York, New York, 10016, United States

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DBV Investigative Site

New York, New York, 10029, United States

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DBV Investigative Site

Rochester, New York, 14642, United States

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DBV Investigative Site

Chapel Hill, North Carolina, 27599, United States

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DBV Investigative Site

Cincinnati, Ohio, 45229, United States

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DBV Investigative Site

Cleveland, Ohio, 44106, United States

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DBV Investigative Site

Cleveland, Ohio, 44195, United States

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DBV Investigative Site

Columbus, Ohio, 43205, United States

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DBV Investigative Site

Philadelphia, Pennsylvania, 19104, United States

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DBV Investigative Site

Pittsburgh, Pennsylvania, 15224, United States

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DBV Investigative Site

Memphis, Tennessee, 38105, United States

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DBV Investigative Site

Nashville, Tennessee, 37232, United States

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DBV Investigative Site

Austin, Texas, 78723, United States

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DBV Investigative Site

Dallas, Texas, 75235, United States

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DBV Investigative Site

Houston, Texas, 77030, United States

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DBV Investigative Site

Seattle, Washington, 98101, United States

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DBV Investigative Site

Seattle, Washington, 98115, United States

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DBV Investigative Site

Milwaukee, Wisconsin, 53226, United States

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DBV Investigative Site

Adelaide, 5006, Australia

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DBV Investigative Site

Nedlands, 6009, Australia

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DBV Investigative Site

Parkville, 3052, Australia

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DBV Investigative Site

Richmond, 3121, Australia

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DBV Investigative Site

South Brisbane, 4101, Australia

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DBV Investigative Site

Westmead, 2145, Australia

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DBV Investigative Site

Vancouver, British Columbia, V6H 3V4, Canada

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DBV Investigative Site

Winnipeg, Manitoba, R3J 0S9, Canada

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DBV Investigative Site

Burlington, Ontario, L7L6W6, Canada

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DBV Investigative Site

North York, Ontario, M3B3S6, Canada

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DBV Investigative Site

Ottawa, Ontario, M5G 1X8, Canada

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DBV Investigative Site

Toronto, Ontario, K1H1E4, Canada

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DBV Investigative Site

Montreal, Quebec, H3T 1C5, Canada

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DBV Investigative Site

Montreal, Quebec, H4A3J1, Canada

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DBV Investigative Site

Québec, Quebec, G1v4W2, Canada

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DBV Investigative Site

Hamilton, L8SIG5, Canada

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DBV Investigative Site

Angers, 49933, France

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DBV Investigative Site

Brest, 29609, France

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DBV Investigative Site

Bron, 69500, France

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DBV Investigative Site

Nice, 06200, France

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DBV Investigative Site

Strasbourg, 67091, France

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DBV Investigative Site

Vandœuvre-lès-Nancy, 54511, France

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DBV Investigative Site

Düsseldorf, 40217, Germany

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DBV Investigative Site

Frankfurt, 60590, Germany

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DBV Investigative Site

Ulm, 89075, Germany

Location

DBV Investigative Site

Cork, T12 DC4A, Ireland

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DBV Investigative Site

Dublin, D12N512, Ireland

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DBV Investigative Site

Rotterdam, 3015 CN, Netherlands

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DBV Investigative Site

Utrecht, 3584 EA, Netherlands

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DBV Investigative Site

Madrid, 28009, Spain

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DBV Investigative Site

Madrid, 28034, Spain

Location

DBV Investigative Site

Málaga, CP 29011, Spain

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DBV Investigative Site

London, SE1 7ETH, United Kingdom

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DBV Investigative Site

London, W2 1NY, United Kingdom

Location

DBV Investigative Site

Manchester, M13 9WL, United Kingdom

Location

DBV Investigative Site

Sheffield, S10 2TH, United Kingdom

Location

DBV Investigative Site

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Nut and Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: February 21, 2023
• Primary Completion: November 6, 2025
• Study Completion (Estimated): October 1, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

GB (5); NL (2); FR (6); US (50); CA (10); IE (2); DE (3); ES (3); AU (6)