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A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)

Trial Profile

A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 25 May 2025

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At a glance

  • Drugs Belumosudil (Primary) ; Prednisolone (Primary) ; Prednisone (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Acronyms ROCKnrol-1
  • Sponsors Sanofi

Most Recent Events

  • 24 Nov 2023 New trial record
  • 23 Nov 2023 Status changed from not yet recruiting to recruiting.

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