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Phase III trial of Viaskin Peanut for the treatment of peanut allergic children in routine clinical practice

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Trial Profile

Phase III trial of Viaskin Peanut for the treatment of peanut allergic children in routine clinical practice

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Feb 2022

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At a glance

  • Drugs Peanut allergy immunotherapy (Primary)
  • Indications Peanut hypersensitivity
  • Focus Registrational; Therapeutic Use
  • Acronyms REALISE
  • Sponsors DBV Technologies

    • Most Recent Events

    • 22 Feb 2022 According to a DBV Technologies media release, pooled safety data from Phase 3 studies of epicutaneous immunotherapy with investigational Viaskin Peanut 250 µg in children aged 4 to 11 years, following treatment for up to 36 months in peanut-allergic children will be presented at the upcoming participation at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Scientific meeting ,2022.
    • 01 Nov 2021 According to a DBV Technologies media release, new long-term results from this trial will be presented at the at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting 2021.
    • 14 Jan 2021 According to a DBV media release, company announced the receipt of written responses from the US FDA to questions provided in the Type A meeting request the Company submitted in October 2020, following the Company's receipt of a Complete Response Letter (CRL). In order to confirm the consistency of efficacy data between the existing and modified patches, FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11.
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