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A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study)

Trial Profile

A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Nov 2019

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At a glance

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

    • 11 Nov 2019 According to an Kadmon Holdings media release, the company will host a conference call and webcast to discuss the topline results of the interim analysis of this study.
    • 11 Nov 2019 According to an Kadmon Holdings media release, the primary analysis of this study will occur in the first quarter of 2020 and the company submit results from this study for presentation at an upcoming scientific meeting.
    • 11 Nov 2019 According to an Kadmon Holdings media release, the company looks forward to sharing the results from this study with the FDA at a pre-NDA meeting and announces intention to submit NDA to US FDA for Graft-versus-host-disease in 2020, subject to FDA input.
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