The primary objective of this phase 2, open-label, single-cohort, multicenter trial is to evaluate the efficacy of belumosudil 200 mg BID using the Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) after 24 weeks of therapy. The duration of the study will be approximately 14 months (4 weeks for screening, 52 weeks of dosing period, and 4 weeks of Follow-up)~Subjects who have signed an Institutional Review Board/Independent Ethics Committee-(IRB/IEC)-approved informed consent form (ICF) and met all of the inclusion/exclusion criteria will be enrolled. A total of 12 to 15 to subjects at approximately 5 to 6 sites will receive belumosudil 200 mg in tablet form administered PO BID for 52 weeks. The total duration of the study is approximately 14 months: a 4-week screening period, a 52-week treatment period, and a 4-week follow-up.~The primary endpoint will be analyzed using Week 24 data.~Efficacy will be assessed throughout the 52-week dosing period using:~Composite Response Index in Systemic Sclerosis (CRISS)~Modified Rodnan Skin Score (mRSS)~Pulmonary Function Tests (PFTs)~Physician Global Assessment~Patient Global Assessment~Safety will be assessed throughout the study and will include:.~Physical examinations (PEs)~Vital sign measurements~Weight measurements~Blood sample collection for hematology and chemistry; urinalysis~Electrocardiograms (ECGs)~Adverse event (AE) assessments~Concomitant medication assessments~Pregnancy testing for females of childbearing potential.~Reasons for discontinuation of treatment because of toxicity will be documented. Careful monitoring of all toxicities will be carried out. Dosing can be reduced 1 dose level. If the dose is not tolerated, then the subject will be discontinued from the study. If there is a interruption of dosing, after 14 days the subject will be discontinued from the study.~Subjects will be given a study drug diary to record the details of each dose of belumosudil 200 mg. Diaries will be dispense/collected on each visit. Compliance with dosing will be confirmed using subject diaries, which will be examined at each visit by site staff to determine if dosing is as instructed per protocol and follow-up.~A 4-Week Safety Follow-up Visit will occur 28 days (± 3 days) after the last dose of study drug.
This is a phase 2, open-label, single-cohort, multicenter trial of belumosudil in subjects with Diffuse Cutaneous Systemic Sclerosis (dcSSc). An estimated total of 12 to 15 subjects will receive belumosudil 200 mg administered orally (PO) twice daily (BID) for 52 weeks. The primary analysis will be at 24 weeks.