Belumosudil in diffuse cutaneous systemic sclerosis: A randomized, double-blind, open-label extension, placebo-controlled, Phase 2 study
Rheumatology 2025;64:4299–4308 Doi: 10.1093/rheumatology/keaf062
Chung et al. showed that this prematurely terminated Phase 2 trial did not identify any trend toward belumosudil efficacy as the combined response index in systemic sclerosis score (CRISS) ≥0.60 responses were similar between belumosudil and placebo groups; but it was found to have acceptable safety and tolerability. Authors evaluated the efficacy, safety and PD of orally administered belumosudil (200mg QD or BID) in patients with dcSSc.
Furthermore, signalling pathway modulation analysis supported the mechanism of action of belumosudil, and a trend for decreased fibrosis-related biomarkers was observed in the belumosudil-treated group. These findings were consistent with previously published studies involving patients with cGVHD.