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An international randomised, multicentre, parallel-group, Phase III comparative study of inolimomab against usual care in the Treatment of Primary Steroid Refractory Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation in adult patients

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Trial Profile

An international randomised, multicentre, parallel-group, Phase III comparative study of inolimomab against usual care in the Treatment of Primary Steroid Refractory Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation in adult patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Dec 2021

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At a glance

  • Drugs Inolimomab (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Sponsors EUSA Pharma

    • Most Recent Events

    • 15 Apr 2021 According to an ElsaLys Biotech media release, the company expects to collect clinical benefit and safety profile data through these compassionate use programs, which will support the companys work on the filing of marketing authorization applications (MAA) in Europe and in the U.S.
    • 15 Apr 2021 According to an ElsaLys Biotech media release, Inolimomab is already being administered in France (CT profile 335961) before marketing authorisation in Europe and hopefully soon in other countries through compassionate use programs as it is considered a reliable treatment of this high-risk patient population with acute cortico-resistant or corticosteroid-dependent graft-versus-host disease.
    • 23 Jan 2019 According to an ElsaLys Biotech media release, the long-term follow-up analysis of this trial patients has evidenced a positive outcome on composite primary endpoint at level of statistical significance set in the protocol (see detailed data page 2) but more importantly a very positive outcome on OS, which is the most robust endpoint of assessment in such life-threatening disease.
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