Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis

Summary

This was a phase 2, open-label, single-cohort, multicenter trial of belumosudil in participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc). An estimated total of 12 to 15 participants would receive belumosudil 200 milligrams (mg) administered orally (PO) twice daily (BID) for 52 weeks. The primary analysis was at 24 weeks.

Timeline

Start

2021-03-03

Primary completion

2022-05-10

Completion

2022-12-19

Outcome

Outcome not reported

Stopped (Enrollment): “Sponsor decision due to slow enrollment and strategic consideration; not driven by any safety concerns.”

Drugs

Indications