V712-306 (VITESSE) Enrolling

Peanut Allergy Research Trial (12 months)


Treatment: Topical Age: 4 to 7 years


Children aged 4 to 7 years of age with a physician-diagnosed peanut allergy may be eligible to enroll. Individuals must be currently following a strict peanut-free diet, have access to emergency medications (including self-injectable epinephrine) and a current food allergy emergy action plan.

Participants will receive investigational epicutaneous immunotherapy (EPIT) patch (active study drug) or placebo.  Study treatment and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last approximately 12 months and involve about 15 visits to the study centre.


Participating Locations

COUNTRY
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Canada

Participating Experts

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The following information is from ClinicalTrials.gov

Last Update Posted: July 16, 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:

    PHASE3

  • Ages Eligible for Study:

    4 Years and 7 Years (CHILD)

  • Sexes Eligible for Study:

    ALL

Children aged 4 to 7 years of age with a physician-diagnosed peanut allergy may be eligible to enroll. Individuals must be currently following a strict peanut-free diet, have access to emergency medications (including self-injectable epinephrine) and a current food allergy emergy action plan.


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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Peanut Allergy - Pediatric

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