Systemic sclerosis (SSc) is a chronic autoimmune disease that causes widespread microvascular damage and excessive deposition of collagen in the skin and internal organs. Limited cutaneous systemic sclerosis is primarily cutaneous, affecting the hands, arms, and face. Diffuse cutaneous systemic sclerosis (dcSSc) is a more serious manifestation of the disease and is often rapidly progressive, not only involving the skin, but also involving internal organs including kidney, heart, and lungs.~Subjects who have signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form and met all of the inclusion/exclusion criteria will be enrolled. A total of 60 subjects will be randomized into 3 groups (1:1:1) to receive orally administered belumosudil 200 mg once daily (QD; n = 20 subjects), belumosudil 200 mg twice daily (BID; n = 20 subjects), or matched placebo (n = 20 subjects) for 28 weeks. The study will be double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the subjects in Group 1 and 2 will continue on the same belumosudil dose whereas the subjects in the placebo group will be re-randomized to either belumosudil 200 mg QD or belumosudil 200 mg BID in 1:1 fashion.
This randomized, placebo-controlled phase 2 study is seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis. Upon eligibility confirmation, a total of 60 adult subjects will be enrolled and randomized into 3 groups (1:1:1) to either receive orally administered belumosudil (200 mg once daily and 200 mg twice daily) or matched placebo for 28 weeks. Study drug dosing will be for 52 weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the subjects on belumosudil will continue on the same belumosudil dose whereas the subjects in the placebo group will be re-randomized to one of the belumosudil doses.