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A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease

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Trial Profile

A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2024

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At a glance

  • Drugs Darvadstrocel (Primary)
  • Indications Rectal fistula
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda

    • Most Recent Events

    • 12 Feb 2023 Status changed from active, no longer recruiting to completed.
    • 27 Sep 2021 According to a Takeda media release, the company received approval from the Japan Ministry of Health, Labour and Welfare to manufacture and market Alofisel (darvadstrocel) for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn's disease (CD), based on data from Darvadstrocel-3002 and ADMIRE-CD trial.
    • 10 Feb 2021 According to a Takeda media release, the company has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (Cx601) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohns disease (CD).The application filing included data from two trials, the Japanese Study Darvadstrocel-3002 and the ADMIRE-CD trial, conducted in Europe and Israel.

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