A Pivotal, Phase II Randomized Trial of KD025 in Patients with Active Chronic Graft-Versus-Host Disease (cGVHD)

Trial Profile

A Pivotal, Phase II Randomized Trial of KD025 in Patients with Active Chronic Graft-Versus-Host Disease (cGVHD)

Planning
Phase of Trial: Phase II

Latest Information Update: 10 Apr 2018

At a glance

  • Drugs KD 025 (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Kadmon Holdings
  • Most Recent Events

    • 10 Apr 2018 According to a Kadmon Holdings media release, the company plans to initiate this trial to support the potential registration of KD025 in chronic graft-versus-host disease (cGVHD).
    • 10 Apr 2018 According to a Kadmon Holdings media release, the company has received final minutes from a March 2018 Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the development pathway for KD025 for the treatment of chronic graft-versus-host disease (cGVHD). Based on the FDAs guidance on the pivotal clinical trial design, the company plans to initiate this trial to support the potential registration of KD025 in cGVHD.
    • 14 Mar 2018 New trial record
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