A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

About the trial

Sponsor

Sanofi

Tested

Belumosudil (drug), Placebo (drug), Prednisone (drug), Prednisolone (drug)

Dates

Started 2024-01-23; completion 2028-09-29

Results posted

Not yet

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, …

From ClinicalTrials.gov, last updated 2026-10-16. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $1.6M in research payments for this study in 2025 (104 payments).

Products named: Rezurock

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.