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V712-306 (VITESSE) Enrolling

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


Age: 4 Years



Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Nestor Cisneros

Pediatric Allergist

Dr. Mariam Hanna

Pediatric Allergist

Dr. Douglas Mack

Pediatric Allergist

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The following information is from ClinicalTrials.gov

Last Update Posted: June 23, 2024

Official Title

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)

ClinicalTrials.gov ID

NCT05741476

Sponsor

DBV Technologies

Study Description

  • 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.

  • Condition or Disease:

    Allergy, Peanut

  • Intervention/Treatment:

    Drug: DBV712
    Other: Placebo
    Drug: DBV712
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    4 Years and 7 Years (Child)

  • Sexes Eligible for Study:

    All

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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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