A Phase 2 interventional study of Belumosudil (KD025) and Placebo in System; Sclerosis and Diffuse Cutaneous Systemic Sclerosis, sponsored by Kadmon, a Sanofi Company. Terminated at 26 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Kadmon, a Sanofi Company (part of Sanofi) · Phase 2, Interventional, and Treatment
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Among 153 studies in Scleroderma, Diffuse with a site in United States — 29 open to participants now, 39 under way, 5 of them phase 3. Scleroderma, Diffuse · United States.
Among the 153 studies in Scleroderma, Diffuse with a site in United States, this one is the 51st largest by enrollment of the 120 interventional ones that give a count, is one of 6 that started in 2019, is one of 41 in phase 2, and was the 94th registered.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
Browse Scleroderma, Diffuse studies →29 of the 153 studies in Scleroderma, Diffuse with a site in United States are open now. Recruiting first, the newest first:
Miltenyi Biomedicine GmbH · Sites in United States
Ages 18+
Mediar Therapeutics · Sites in United States, Australia, France and 7 more countries
Ages 18+
Galderma R&D · Sites in United States, Switzerland
Ages 18+
Allogene Therapeutics · Sites in United States, Canada
Ages 18–74
Boston University · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 55 Scleroderma, Diffuse studies recruiting now, 28 (51%) set no upper age limit and 20 (36%) stop at 75 or younger; 10 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
153 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 38 · Phase 2 62 · Phase 3 18 · Phase 4 2
First in 1992; this study’s year is marked. 6 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is close to the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Median enrollment 29 across the 120 interventional studies, 197 across the 32 observational. Of the 100 that completed or were terminated, 40 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
61 of 153 have an industry lead sponsor. The 10 most frequent:
This study is registered under Kadmon, a Sanofi Company, one of the names counted as Sanofi. Under that name alone:
Kadmon, a Sanofi Company is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Sanofi has 3 studies filed under Scleroderma, Diffuse — fewer than ten, so there is no comparison to draw.
8 of the studies in Scleroderma, Diffuse with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06195072Scleroderma Research Foundation, Inc.Platform Clinical Study for Conquering Scleroderma | 2026-11 |
| NCT03276923Duke UniversityMaternal Autoimmune Disease Research Alliance (MADRA) Registry | 2027-01-01 |
| NCT06152172David PorterCARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 | 2027-02 |
| NCT06843239Zura Bio IncTibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) | 2027-05 |
Add all 8 to your calendar (.ics) → With an account.
Among the 153 studies in Scleroderma, Diffuse with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis. Enrolment was terminated earlier than planned for business reasons unrelated to safety. A total of 36 participants were enrolled and randomized into 3 groups to either receive orally administered belumosudil (200 milligrams [mg] once daily [QD] and 200 mg twice daily [BID]) or matched placebo in 1:1:1 ratio in the double-blind (DB) period of this study. Study drug dosing was for 52 weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the participants on belumosudil continued on the same belumosudil dose whereas the participants in the placebo group were re-randomized to one of the belumosudil doses in a 1:1 ratio.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Active disease defined as any of the following within the 6 months prior to screening:
Adequate organ and bone marrow functions evaluated during the 28 days prior to enrollment as follows:
Female participants of had a negative pregnancy test at screening. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received belumosudil 200 mg tablet, QD orally for 28 weeks during the DB period. After completion of DB period, participants entered open-label extension (OLE) period and continued to receive belumosudil 200 mg tablet QD orally for 24 weeks in OLE period (i.e., up to Week 52).
Drug: Belumosudil (KD025)
Participants received belumosudil 200 mg tablet BID orally, for 28 weeks during the DB period. After completion of DB period, participants entered OLE period and continued to receive belumosudil 200 mg tablet BID orally for 24 weeks in OLE period (i.e., up to Week 52).
Drug: Belumosudil (KD025)
Participants received placebo (matched to belumosudil) tablet, orally for 28 weeks during the DB period.
Drug: Placebo
Participants who had received placebo in the DB period were entered and re-randomized into OLE period and received belumosudil 200 mg tablet QD orally for 24 weeks (i.e., up to Week 52) in the OLE period.
Drug: Belumosudil (KD025)
Participants who had received placebo in the DB period were entered and re-randomized into OLE period and received belumosudil 200 mg tablet BID orally for 24 weeks (i.e., up to Week 52) in the OLE period.
Drug: Belumosudil (KD025)
ROCK-2 Inhibitor
Inactive substance
DB Period: Number of Participants With Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) Score Greater Than or Equal to (>=) 60 Percent (%) at Week 24
CRISS components included the following domains: mRSS, FVC percent predicted, physician global assessment, patient global assessment, and SHAQ-DI. An algorithm determines the predicted probability of improvement from Baseline by incorporating change from baseline in the mRSS, FVC percent predicted, physician and patient global assessments, and SHAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 to 100%). Higher score indicated greater probability of improvement. CRISS score \>= 60% was considered the minimally important difference. Participants were not considered improved and assigned a probability of improving equal to 0.0 if they developed new onset of renal crisis, new onset or worsening of lung fibrosis, new onset of pulmonary arterial hypertension, or new onset of left ventricular failure during the trial. Last observation carried forward (LOCF) method was used to handle missing data.
Time frame: Week 24
DB Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 24
CRISS components included the following domains: mRSS, FVC percent predicted, physician global assessment, patient global assessment, and SHAQ-DI. An algorithm determines the predicted probability of improvement from Baseline by incorporating change from baseline in the mRSS, FVC percent predicted, physician and patient global assessments, and SHAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 to 100%). A higher score indicated greater probability of improvement. Participants were not considered improved and assigned a probability of improving equal to 0.0 if they developed new onset of renal crisis, new onset or worsening of lung fibrosis, new onset of pulmonary arterial hypertension, new onset of left ventricular failure during the trial. Least squares (LS) mean and 95% confidence interval (CI) were obtained by mixed-effect model for repeated measures (MMRM).
Time frame: Week 24
OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52
CRISS components included following domains: mRSS, percent predicted FVC, physician global assessment, patient global assessment, and SHAQ-DI. An algorithm determines the predicted probability of improvement from Baseline by incorporating change from baseline in the mRSS, FVC percent predicted, physician and patient global assessments, and SHAQ-DI. The outcome was a continuous variable between 0.0 and 1.0 (0 to 100%). Higher score indicated greater probability of improvement. Participants were not considered improved and assigned a probability of improving equal to 0.0 if they developed new onset of renal crisis, new onset or worsening of lung fibrosis, new onset of pulmonary arterial hypertension, new onset of left ventricular failure during the trial. LOCF method was used to handle missing data.
Time frame: Week 52
DB Period: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
mRSS is an accepted clinical measure of skin thickness. The investigator assessed the skin thickness using the mRSS through simple palpation on 17 different skin sites (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual site skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (normal skin) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. LS mean and 95% CI were calculated using MMRM model.
Time frame: Baseline, Week 24
DB Period: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24
FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying interstitial lung disease (ILD). LS mean and 95% CI were obtained from MMRM model.
Time frame: Baseline, Week 24
DB Period: Change From Baseline in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24
The Physician Global Assessment (reported by the physician) quantified the participant's overall health during the last week based on VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. LS mean and 95% CI were obtained from MMRM model.
Time frame: Baseline, Week 24
DB Period: Change From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24
The Patient Global Assessment (reported by participant) quantified the participant's overall health during the last week based on a VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. LS mean and 95% CI were obtained from MMRM model.
Time frame: Baseline, Week 24
DB Period: Change From Baseline in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24
SHAQ-DI included the general health assessment questionnaire-disability index (HAD-DI) assessment and 6 scleroderma-specific VAS items to explore impact of participant's disease. General HAD-DI assessment included 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities addressing scleroderma related manifestations that contribute to disability. It is a quality of life measure. For each question, level of difficulty was scored from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do. Some domains in the SHAQ are visual analog scales that are measured first and then changed to a 0-3 scale. SHAQ-DI total score was computed as the sum of domain scores divided by the number of domains answered and it ranged from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability/worse functionality. LS mean and 95% CI were obtained from MMRM model.
Time frame: Baseline, Week 24
DB Period: Percentage Improvement in Modified Rodnan Skin Score at Week 24
The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the skin thickness using the mRSS through simple palpation on 17 different skin sites (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet). Each skin site was rated on 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual site skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (normal skin) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. LS mean and 95% CI were obtained from MMRM model.
Time frame: Baseline, Week 24
DB Period: Percentage Improvement in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 24
The Physician Global Assessment (reported by the physician) quantified the participant's overall health during the last week based on VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. LS mean and 95% CI were obtained from MMRM model.
Time frame: Baseline, Week 24
DB Period: Percentage Improvement in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24
The Patient Global Assessment (reported by participant) quantified the participant's overall health during the last week based on a VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. LS mean and 95% CI were obtained from MMRM model.
Time frame: Baseline, Week 24
DB Period: Percentage Improvement in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24
SHAQ-DI included general HAD-DI assessment and 6 scleroderma-specific VAS items to explore impact of participant's disease. General HAD-DI assessment included 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities addressing scleroderma related manifestations that contribute to disability. For each question, level of difficulty was scored from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do. Some domains in SHAQ are visual analog scales that are measured first and then changed to 0-3 scale. SHAQ-DI total score was computed as sum of domain scores divided by number of domains answered and it ranged from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability/worse functionality. Percentage improvement = change from Baseline value divided by Baseline value\*100. LS mean and 95% CI were obtained from MMRM model.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Modified Rodnan Skin Score at Week 52
The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the skin thickness using the mRSS through simple palpation on 17 different skin sites (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual site skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (normal skin) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. In the below data table, 'number analyzed' = participants with available data for each specified category.
Time frame: Baseline, Week 52
OLE Period: Change From Baseline in Percent Predicted Forced Vital Capacity at Week 52
FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying ILD. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
OLE Period: Change From Baseline in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 52
The Physician Global Assessment (reported by the physician) quantified the participant's overall health during the last week based on VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
OLE Period: Change From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 52
The Patient Global Assessment (reported by participant) quantified the participant's overall health during the last week based on a VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
OLE Period: Change From Baseline in Scleroderma Health Assessment Questionnaire-Disability Index Total Score at Week 52
SHAQ-DI included general HAD-DI assessment and 6 scleroderma-specific VAS items to explore the impact of participant's disease. General HAD-DI assessment included 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities addressing scleroderma related manifestations that contribute to disability. For each question, level of difficulty was scored from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do. Some domains in SHAQ are visual analog scales that are measured first and then changed to a 0-3 scale. SHAQ-DI total score was computed as sum of domain scores divided by the number of domains answered and it ranged from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability/worse functionality. In the data table below, 'number analyzed' = participants with available data for each specified category.
Time frame: Baseline, Week 52
OLE Period: Percentage Improvement in Modified Rodnan Skin Score at Week 52
The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the skin thickness using the mRSS through simple palpation on 17 different skin sites in (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual site skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (normal skin) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. In the data table below, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Time frame: Baseline, Week 52
OLE Period: Percentage Improvement Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 52
The Physician Global Assessment (reported by the physician) quantified the participant's overall health during the last week based on VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. In the data below, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Time frame: Baseline, Week 52
OLE Period: Percentage Improvement in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 52
The Patient Global Assessment (reported by participant) quantified the participant's overall health during the last week based on a VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. In the data table below, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Time frame: Baseline, Week 52
OLE Period: Percentage Improvement in Scleroderma Health Assessment Questionnaire-Disability Index Score at Week 52
SHAQ-DI: general health assessment questionnaire-disability index (HAD-DI) assessment and 6 scleroderma-specific VAS items to explore impact of participant's disease. General HAD-DI assessment included 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities addressing scleroderma related manifestations that contribute to disability. For each question, level of difficulty was scored from 0 to 3; 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do. Some domains in SHAQ are visual analog scales that are measured first and then changed to 0-3 scale. SHAQ-DI total score computed as sum of domain scores divided by number of domains answered ranging 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability/worse functionality. Percentage improvement = change from Baseline value divided by Baseline value\*100. 'overall number of participants analyzed' = participants with available data for this outcome measure.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Percent Predicted Forced Vital Capacity Level at Week 24-ILD Participants
FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying ILD. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted FVC level at Week 24 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 24
DB Period: Change From Baseline in Percent Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 24-ILD Participants
DLco is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted DLco at Week 24 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 24
DB Period: Change From Baseline in Percent Predicted Forced Expiratory Volume (FEV1) at Week 24-ILD Participants
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by a spirometer. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted FEV1 at Week 24 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 24
DB Period: Change From Baseline in Percent Predicted Residual Volume (RV) at Week 24-ILD Participants
RV is the volume of air remaining in the lungs after maximum forceful expiration. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted RV at Week 24 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 24
DB Period: Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Week 24-ILD Participants
TLC is the volume of air in the lungs upon the maximum effort of inspiration. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted TLC at Week 24 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Percent Predicted Forced Vital Capacity at Week 52-ILD Participants
FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying ILD. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted FVC at Week 52 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 52
OLE Period: Change From Baseline in Percent Predicted Diffusing Capacity of the Lungs for Carbon Monoxide at Week 52-ILD Participants
DLco is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted DLco at Week 52 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 52
OLE Period: Change From Baseline in Percent Predicted Forced Expiratory Volume at Week 52-ILD Participants
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by a spirometer. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted FEV1 at Week 52 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 52
OLE Period: Change From Baseline in Percent Predicted Residual Volume at Week 52-ILD Participants
RV is the volume of air remaining in the lungs after maximum forceful expiration. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted RV at Week 52 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 52
OLE Period: Change From Baseline in Percent Predicted Total Lung Capacity at Week 52-ILD Participants
TLC is the volume of air in the lungs upon the maximum effort of inspiration. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted TLC at Week 52 in participants with ILD is reported in this outcome measure.
Time frame: Baseline, Week 52
DB Period: Number of Participants With Lung Fibrosis at Baseline and Week 24-ILD Participants
Lung fibrosis is a lung disease in which lung tissue becomes damaged and scared. Lung fibrosis was assessed using high-resolution computerized tomography (HRCT). HRCT is a type of computed tomography used to diagnose and stage the severity. Pure ground-class opacity, pulmonary fibrosis and honeycombing were recorded for each lung (right and left) and three lung zones (upper, middle, and lower). They were recorded categorically for the amount detected, ranged as Absent, 1-25%, 26-50%, 51-75% and \>75% for abnormality/lung fibrosis. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Number of participants with lung fibrosis at Baseline and Week 24 are reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Number of Participants With Lung Fibrosis at Baseline and Week 52-ILD Participants
Lung fibrosis is a lung disease in which lung tissue becomes damaged and scared. Lung fibrosis was assessed using HRCT. HRCT is a type of computed tomography used to diagnose and stage the severity. Pure ground-class opacity, pulmonary fibrosis and honeycombing were recorded for each lung (right and left) and three lung zones (upper, middle, and lower). They were recorded categorically for the amount detected, ranged as Absent, 1-25%, 26-50%, 51-75% and \>75% for abnormality/lung fibrosis. Number of participants with lung fibrosis at Baseline and Week 52 are reported in this outcome measure. In the data table below, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Time frame: Baseline, Week 52
DB Period: Pharmacokinetics: Plasma Concentration of Belumosudil and Its Metabolite (KD025m2)
Plasma concentration of belumosudil and its metabolite (KD025m2) at pre-dose and 3 hours post-dose at Week 4 and 8 is reported in this outcome measure. The Lower Limit of Quantification (LLOQ) was 10 nanograms per milliliter (ng/mL).
Time frame: Pre-dose and 3 hours post-dose at Week 4 and 8
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Adverse event (AE): any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs: AEs with onset after the first dose of study drug or existing AEs that worsened during TEAE Period (for DB period: From Day 1 (Week 0) up to Week 28; for OLE period: from Week 29 up to 4 weeks post last study drug administration).
Time frame: For DB period: From Day 1 (Week 0) up to Week 28; for OLE period: from Week 29 up to 4 weeks post last study drug administration (i.e., up to Week 56)
DB Period: Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure at Week 24
Vital signs (systolic and diastolic blood pressure) were measured with the participants after having rested in sitting position. Vital signs assessments were performed before the electrocardiogram (ECG) and other scheduled assessments. Change from Baseline in systolic and diastolic blood pressure at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE: Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure at Week 52
Change from Baseline in systolic and diastolic blood pressure at Week 52 was reported in this outcome measure. Vital signs (systolic and diastolic blood pressure) were measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other schedules assessments. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Vital Signs: Pulse at Week 24
Vital sign (pulse) was measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other scheduled assessments. Change from Baseline in vital signs: pulse at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Vital Signs: Pulse at Week 52
Vital sign (pulse) was measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other scheduled assessments. Change from Baseline in vital signs: pulse at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Vital Signs: Respiratory Rate at Week 24
Vital sign (respiratory rate) was measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other scheduled assessments. Change from Baseline in vital signs: respiratory rate at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Vital Signs: Respiratory Rate at Week 52
Vital sign (respiratory rate) was measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other scheduled assessments. Change from Baseline in vital signs: respiratory rate at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in 12-lead Electrocardiogram (ECG) Values: Heart Rate at Week 24
ECGs were recorded after the participant had rested in the supine position for at least 5 minutes and were performed prior to any blood sample collection. Change from Baseline in 12-lead ECG values: heart rate at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in 12-lead Electrocardiogram Values: Heart Rate at Week 52
ECGs were recorded after the participant had rested in the supine position for at least 5 minutes and were performed prior to any blood sample collection. Change from Baseline in 12-lead ECG values: heart rate at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in 12-lead Electrocardiogram Values: PR Interval, RR Interval, QRS Interval, QT Interval and QTcF Interval at Week 24
ECGs were recorded after the participant had rested in the supine position for at least 5 minutes and were performed prior to any blood sample collection. Change from Baseline in 12-lead ECG values: PR interval, RR interval, QRS interval, QT interval and QTcF interval at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in 12-lead Electrocardiogram Values: PR Interval, RR Interval, QRS Interval, QT Interval and QTcF Interval at Week 52
ECGs were recorded after the participant had rested in the supine position for at least 5 minutes and were performed prior to any blood sample collection. Change from Baseline in 12-lead ECG values: PR interval, RR interval, QRS interval, QT interval and QTcF interval at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Hematological Parameters: Percentage of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes at Week 24
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameters: percentage of basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Hematological Parameters: Percentage of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes at Week 52
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameters: percentage of basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Hematological Parameter: Hematocrit at Week 24
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter (hematocrit, fraction of 1.0) at Week 24 was reported in this outcome measure. The hematocrit is percentage of the volume of whole blood that is made up of red blood cells.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Hematological Parameter: Hematocrit at Week 52
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter (hematocrit, fraction of 1.0) at Week 52 was reported in this outcome measure. The hematocrit is percentage of the volume of whole blood that is made up of red blood cells. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Hematological Parameter: Hemoglobin at Week 24
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: hemoglobin at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Hematological Parameter: Hemoglobin at Week 52
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: hemoglobin at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Hematological Parameter: Erythrocytes Mean Corpuscular Volume at Week 24
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: erythrocytes mean corpuscular volume at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Hematological Parameter: Erythrocytes Mean Corpuscular Volume at Week 52
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: erythrocytes mean corpuscular volume at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Hematological Parameter: Platelets at Week 24
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: platelets at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Hematological Parameter: Platelets at Week 52
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: platelets at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Hematological Parameter: Erythrocytes at Week 24
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: erythrocytes at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Hematological Parameter: Erythrocytes at Week 52
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: erythrocytes at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Hematological Parameter: Leukocytes at Week 24
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: leukocytes at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Hematological Parameter: Leukocytes at Week 52
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: leukocytes at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Clinical Chemistry Parameter: Albumin, Globulin and Protein at Week 24
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: albumin, globulin and protein at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Clinical Chemistry Parameter: Albumin, Globulin and Protein at Week 52
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: albumin, globulin and protein at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Clinical Chemistry Parameter: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Week 24
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, and lactate dehydrogenase at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Clinical Chemistry Parameter: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Week 52
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, and lactate dehydrogenase at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Clinical Chemistry Parameter: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Glucose, Potassium, Magnesium, Phosphate and Sodium at Week 24
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: bicarbonate, blood urea nitrogen, calcium, chloride, glucose, potassium, magnesium, phosphate and sodium at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Clinical Chemistry Parameter: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Glucose, Potassium, Magnesium, Phosphate and Sodium at Week 52
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: bicarbonate, blood urea nitrogen, calcium, chloride, glucose, potassium, magnesium, phosphate and sodium at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine and Urate at Week 24
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: direct bilirubin, bilirubin, creatinine and urate at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine and Urate at Week 52
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: direct bilirubin, bilirubin, creatinine and urate at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Clinical Chemistry Parameter: Calcium Corrected at Week 24
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: calcium corrected at Week 24 was reported in this outcome measure.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Clinical Chemistry Parameter: Calcium Corrected at Week 52
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: calcium corrected at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
DB Period: Change From Baseline in Clinical Chemistry Parameter: Glomerular Filtration Rate at Week 24
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: glomerular filtration rate at Week 24 was reported in this outcome measure. Expanded unit of measure is milliliter per minute per 1.73 square meters.
Time frame: Baseline, Week 24
OLE Period: Change From Baseline in Clinical Chemistry Parameter: Glomerular Filtration Rate at Week 52
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: glomerular filtration rate at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
Time frame: Baseline, Week 52
The study was conducted at 26 active sites in the United States. A total of 48 participants were screened from 26 June 2019 to 24 January 2022, of which 12 participants were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
| Milestone | Belumosudil QD/Belumosudil QD | Belumosudil BID/Belumosudil BID | DB Period: Placebo | OLE Period: Placebo/Belumosudil QD | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|---|
| Started | 12 | 12 | 12 | 0 | 0 |
| Treated | 11 | 12 | 12 | 0 | 0 |
| Completed | 10 | 10 | 11 | 0 | 0 |
| Not completed | 2 | 2 | 1 | 0 | 0 |
| Withdrew: Randomized not treated | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 |
| Milestone | Belumosudil QD/Belumosudil QD | Belumosudil BID/Belumosudil BID | DB Period: Placebo | OLE Period: Placebo/Belumosudil QD | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|---|
| Started | 10 | 10 | 0 | 5 | 6 |
| Completed | 10 | 7 | 0 | 5 | 6 |
| Not completed | 0 | 3 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Other-unspecified | 0 | 1 | 0 | 0 | 0 |
CRISS components included the following domains: mRSS, FVC percent predicted, physician global assessment, patient global assessment, and SHAQ-DI. An algorithm determines the predicted probability of improvement from Baseline by incorporating change from baseline in the mRSS, FVC percent predicted, physician and patient global assessments, and SHAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 to 100%). Higher score indicated greater probability of improvement. CRISS score \>= 60% was considered the minimally important difference. Participants were not considered improved and assigned a probability of improving equal to 0.0 if they developed new onset of renal crisis, new onset or worsening of lung fibrosis, new onset of pulmonary arterial hypertension, or new onset of left ventricular failure during the trial. Last observation carried forward (LOCF) method was used to handle missing data.
| Participants | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Number of Participants With Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) Score Greater Than or Equal to (>=) 60 Percent (%) at Week 24 | 6 | 3 | 7 |
CRISS components included the following domains: mRSS, FVC percent predicted, physician global assessment, patient global assessment, and SHAQ-DI. An algorithm determines the predicted probability of improvement from Baseline by incorporating change from baseline in the mRSS, FVC percent predicted, physician and patient global assessments, and SHAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 to 100%). A higher score indicated greater probability of improvement. Participants were not considered improved and assigned a probability of improving equal to 0.0 if they developed new onset of renal crisis, new onset or worsening of lung fibrosis, new onset of pulmonary arterial hypertension, new onset of left ventricular failure during the trial. Least squares (LS) mean and 95% confidence interval (CI) were obtained by mixed-effect model for repeated measures (MMRM).
| score on a scale | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 24 | 14.30 (9.47 to 19.12) | 10.16 (5.41 to 14.91) | 14.34 (10.04 to 18.64) |
CRISS components included following domains: mRSS, percent predicted FVC, physician global assessment, patient global assessment, and SHAQ-DI. An algorithm determines the predicted probability of improvement from Baseline by incorporating change from baseline in the mRSS, FVC percent predicted, physician and patient global assessments, and SHAQ-DI. The outcome was a continuous variable between 0.0 and 1.0 (0 to 100%). Higher score indicated greater probability of improvement. Participants were not considered improved and assigned a probability of improving equal to 0.0 if they developed new onset of renal crisis, new onset or worsening of lung fibrosis, new onset of pulmonary arterial hypertension, new onset of left ventricular failure during the trial. LOCF method was used to handle missing data.
| score on a scale | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52 | 87.46 ± 27.376 | 7.16 ± 8.749 | 64.37 ± 41.950 | 11.62 ± 19.282 |
mRSS is an accepted clinical measure of skin thickness. The investigator assessed the skin thickness using the mRSS through simple palpation on 17 different skin sites (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual site skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (normal skin) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. LS mean and 95% CI were calculated using MMRM model.
| score on a scale | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | -9.2 (-12.2 to -6.2) | -4.0 (-7.0 to -1.0) | -8.6 (-11.4 to -5.8) |
FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying interstitial lung disease (ILD). LS mean and 95% CI were obtained from MMRM model.
| percent predicted FVC | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 | 0.6 (-4.0 to 5.2) | -2.3 (-7.2 to 2.5) | -0.8 (-5.2 to 3.6) |
The Physician Global Assessment (reported by the physician) quantified the participant's overall health during the last week based on VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. LS mean and 95% CI were obtained from MMRM model.
| score on a scale | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | 22.4 (10.0 to 34.8) | -0.8 (-13.2 to 11.6) | 7.8 (-4.1 to 19.6) |
The Patient Global Assessment (reported by participant) quantified the participant's overall health during the last week based on a VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. LS mean and 95% CI were obtained from MMRM model.
| score on a scale | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | -5.8 (-22.4 to 10.8) | 3.5 (-13.1 to 20.1) | 4.2 (-11.4 to 19.8) |
SHAQ-DI included the general health assessment questionnaire-disability index (HAD-DI) assessment and 6 scleroderma-specific VAS items to explore impact of participant's disease. General HAD-DI assessment included 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities addressing scleroderma related manifestations that contribute to disability. It is a quality of life measure. For each question, level of difficulty was scored from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do. Some domains in the SHAQ are visual analog scales that are measured first and then changed to a 0-3 scale. SHAQ-DI total score was computed as the sum of domain scores divided by the number of domains answered and it ranged from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability/worse functionality. LS mean and 95% CI were obtained from MMRM model.
| score on a scale | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24 | -0.187 (-0.449 to 0.074) | -0.112 (-0.374 to 0.149) | -0.152 (-0.393 to 0.090) |
The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the skin thickness using the mRSS through simple palpation on 17 different skin sites (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet). Each skin site was rated on 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual site skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (normal skin) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. LS mean and 95% CI were obtained from MMRM model.
| percentage improvement | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Percentage Improvement in Modified Rodnan Skin Score at Week 24 | 37.268 (23.074 to 51.462) | 19.262 (5.068 to 33.457) | 40.277 (27.047 to 53.507) |
The Physician Global Assessment (reported by the physician) quantified the participant's overall health during the last week based on VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. LS mean and 95% CI were obtained from MMRM model.
| percentage improvement | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Percentage Improvement in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 24 | 68.790 (38.465 to 99.115) | 1.240 (-29.085 to 31.564) | 23.224 (-5.757 to 52.204) |
The Patient Global Assessment (reported by participant) quantified the participant's overall health during the last week based on a VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. LS mean and 95% CI were obtained from MMRM model.
| percentage improvement | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Percentage Improvement in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | -2.583 (-42.146 to 36.981) | 18.194 (-21.369 to 57.758) | 14.174 (-22.838 to 51.186) |
SHAQ-DI included general HAD-DI assessment and 6 scleroderma-specific VAS items to explore impact of participant's disease. General HAD-DI assessment included 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities addressing scleroderma related manifestations that contribute to disability. For each question, level of difficulty was scored from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do. Some domains in SHAQ are visual analog scales that are measured first and then changed to 0-3 scale. SHAQ-DI total score was computed as sum of domain scores divided by number of domains answered and it ranged from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability/worse functionality. Percentage improvement = change from Baseline value divided by Baseline value\*100. LS mean and 95% CI were obtained from MMRM model.
| percentage improvement | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Percentage Improvement in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24 | 12.065 (-54.683 to 78.813) | -37.898 (-101.221 to 25.424) | 4.544 (-53.353 to 62.440) |
The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the skin thickness using the mRSS through simple palpation on 17 different skin sites (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual site skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (normal skin) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. In the below data table, 'number analyzed' = participants with available data for each specified category.
| score on a scale | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 25.7 ± 6.15 | 12.8 ± 9.91 | 24.0 ± 4.81 | 14.7 ± 5.75 |
| Change at Week 52 | -14.4 ± 4.09 | -2.0 ± 5.10 | -9.4 ± 3.51 | -2.5 ± 1.64 |
FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying ILD. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| percent predicted FVC | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 98.5 ± 16.77 | 95.8 ± 11.26 | 83.3 ± 17.47 | 76.7 ± 18.42 |
| Change at Week 52 | -4.1 ± 5.36 | 1.0 ± 6.71 | -0.7 ± 13.69 | 2.7 ± 4.18 |
The Physician Global Assessment (reported by the physician) quantified the participant's overall health during the last week based on VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| score on a scale | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 41.5 ± 18.02 | 60.6 ± 20.66 | 59.7 ± 12.87 | 43.3 ± 25.07 |
| Change at Week 52 | 22.2 ± 27.80 | -6.2 ± 18.51 | 7.0 ± 29.58 | 3.3 ± 17.45 |
The Patient Global Assessment (reported by participant) quantified the participant's overall health during the last week based on a VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| score on a scale | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 61.1 ± 17.24 | 51.8 ± 26.85 | 57.6 ± 18.50 | 43.7 ± 20.72 |
| Change at Week 52 | -12.1 ± 30.58 | 15.0 ± 29.91 | -2.4 ± 13.82 | 16.2 ± 33.91 |
SHAQ-DI included general HAD-DI assessment and 6 scleroderma-specific VAS items to explore the impact of participant's disease. General HAD-DI assessment included 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities addressing scleroderma related manifestations that contribute to disability. For each question, level of difficulty was scored from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do. Some domains in SHAQ are visual analog scales that are measured first and then changed to a 0-3 scale. SHAQ-DI total score was computed as sum of domain scores divided by the number of domains answered and it ranged from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability/worse functionality. In the data table below, 'number analyzed' = participants with available data for each specified category.
| score on a scale | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 1.513 ± 0.753 | 1.275 ± 0.582 | 1.388 ± 0.686 | 1.042 ± 0.727 |
| Change at Week 52 | -0.200 ± 0.422 | -0.050 ± 0.068 | -0.089 ± 0.312 | 0.063 ± 0.172 |
The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the skin thickness using the mRSS through simple palpation on 17 different skin sites in (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual site skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (normal skin) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. In the data table below, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| percentage improvement | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Percentage Improvement in Modified Rodnan Skin Score at Week 52 | 57.119 ± 13.719 | -13.687 ± 76.463 | 41.123 ± 16.813 | 20.959 ± 14.344 |
The Physician Global Assessment (reported by the physician) quantified the participant's overall health during the last week based on VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. In the data below, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| percentage improvement | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Percentage Improvement Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 52 | 76.075 ± 73.169 | -8.138 ± 29.916 | 22.014 ± 56.885 | 24.287 ± 71.494 |
The Patient Global Assessment (reported by participant) quantified the participant's overall health during the last week based on a VAS which ranged from 0 (extremely poor) to 100 (excellent). Higher score indicated better outcome. Percentage improvement = change from Baseline value divided by Baseline value\*100. In the data table below, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| percentage improvement | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Percentage Improvement in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 52 | -7.833 ± 57.154 | 40.966 ± 82.168 | -3.797 ± 26.577 | 79.771 ± 122.523 |
SHAQ-DI: general health assessment questionnaire-disability index (HAD-DI) assessment and 6 scleroderma-specific VAS items to explore impact of participant's disease. General HAD-DI assessment included 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities addressing scleroderma related manifestations that contribute to disability. For each question, level of difficulty was scored from 0 to 3; 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do. Some domains in SHAQ are visual analog scales that are measured first and then changed to 0-3 scale. SHAQ-DI total score computed as sum of domain scores divided by number of domains answered ranging 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability/worse functionality. Percentage improvement = change from Baseline value divided by Baseline value\*100. 'overall number of participants analyzed' = participants with available data for this outcome measure.
| percentage improvement | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Percentage Improvement in Scleroderma Health Assessment Questionnaire-Disability Index Score at Week 52 | 15.496 ± 33.762 | 5.667 ± 8.788 | -33.254 ± 118.780 | -15.347 ± 35.326 |
FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying ILD. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted FVC level at Week 24 in participants with ILD is reported in this outcome measure.
| percent predicted FVC | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Baseline | 93.3 ± 13.15 | 81.3 ± 15.77 | 80.2 ± 19.79 |
| Change at Week 24 | -2.3 ± 15.73 | -2.2 ± 5.45 | 0.4 ± 2.79 |
DLco is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted DLco at Week 24 in participants with ILD is reported in this outcome measure.
| percent predicted DLco | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Baseline | 76.3 ± 20.45 | 60.3 ± 15.98 | 60.5 ± 10.21 |
| Change at Week 24 | -6.3 ± 10.21 | 4.4 ± 7.47 | 1.3 ± 4.16 |
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by a spirometer. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted FEV1 at Week 24 in participants with ILD is reported in this outcome measure.
| percent predicted FEV1 | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Baseline | 95.3 ± 7.37 | 83.1 ± 14.88 | 86.4 ± 17.29 |
| Change at Week 24 | -8.7 ± 12.22 | -2.2 ± 6.02 | 0.8 ± 2.75 |
RV is the volume of air remaining in the lungs after maximum forceful expiration. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted RV at Week 24 in participants with ILD is reported in this outcome measure.
| percent predicted RV | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Baseline | 80.7 ± 26.58 | 73.7 ± 24.37 | 69.8 ± 27.97 |
| Change at Week 24 | -17.7 ± 8.96 | 0.2 ± 16.60 | 29.5 ± 18.08 |
TLC is the volume of air in the lungs upon the maximum effort of inspiration. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Change from Baseline in percent predicted TLC at Week 24 in participants with ILD is reported in this outcome measure.
| percent predicted TLC | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Baseline | 89.0 ± 18.03 | 79.0 ± 15.83 | 80.6 ± 19.71 |
| Change at Week 24 | -11.3 ± 4.62 | -2.2 ± 4.02 | 10.5 ± 7.05 |
FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying ILD. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted FVC at Week 52 in participants with ILD is reported in this outcome measure.
| percent predicted FVC | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 93.3 ± 13.15 | 97.5 ± 16.26 | 80.5 ± 17.12 | 68.0 ± 20.66 |
| Change at Week 52 | -7.3 ± 3.59 | -4.0 ± 2.83 | 3.7 ± 12.50 | 4.0 ± 5.29 |
DLco is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted DLco at Week 52 in participants with ILD is reported in this outcome measure.
| percent predicted DLco | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 76.3 ± 20.45 | 78.0 ± 7.07 | 60.3 ± 15.98 | 56.3 ± 2.08 |
| Change at Week 52 | -9.0 ± 9.27 | 2.0 ± 7.07 | 6.0 ± 7.21 | 1.7 ± 11.72 |
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by a spirometer. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted FEV1 at Week 52 in participants with ILD is reported in this outcome measure.
| percent predicted FEV1 | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 95.3 ± 7.37 | 101.5 ± 13.44 | 81.0 ± 15.07 | 70.0 ± 19.00 |
| Change at Week 52 | -6.8 ± 2.06 | -2.0 ± 4.24 | 4.0 ± 14.18 | -0.7 ± 7.09 |
RV is the volume of air remaining in the lungs after maximum forceful expiration. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted RV at Week 52 in participants with ILD is reported in this outcome measure.
| percent predicted RV | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 80.7 ± 26.58 | 113.0 ± 36.77 | 76.2 ± 25.73 | 81.7 ± 31.66 |
| Change at Week 52 | -21.3 ± 22.50 | -28.0 ± 35.36 | 3.7 ± 11.93 | -22.5 ± 7.78 |
TLC is the volume of air in the lungs upon the maximum effort of inspiration. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period. Change from Baseline in percent predicted TLC at Week 52 in participants with ILD is reported in this outcome measure.
| percent predicted TLC | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Baseline | 89.0 ± 18.03 | 104.0 ± 14.14 | 79.7 ± 17.24 | 80.7 ± 19.14 |
| Change at Week 52 | -13.0 ± 11.14 | -10.0 ± 8.49 | 3.3 ± 3.06 | -11.0 ± 4.24 |
Lung fibrosis is a lung disease in which lung tissue becomes damaged and scared. Lung fibrosis was assessed using high-resolution computerized tomography (HRCT). HRCT is a type of computed tomography used to diagnose and stage the severity. Pure ground-class opacity, pulmonary fibrosis and honeycombing were recorded for each lung (right and left) and three lung zones (upper, middle, and lower). They were recorded categorically for the amount detected, ranged as Absent, 1-25%, 26-50%, 51-75% and \>75% for abnormality/lung fibrosis. For participants who received placebo/belumosudil in the DB period, the Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in the DB period. Number of participants with lung fibrosis at Baseline and Week 24 are reported in this outcome measure.
| Participants | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Honeycombing Left Lung Zone 1 - Baseline: Absent | 4 | 7 | 4 |
| Honeycombing Left Lung Zone 1 - Baseline: 1-25% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Week 24: Absent | 3 | 6 | 4 |
| Honeycombing Left Lung Zone 1 - Week 24: 1-25% | 1 | 0 | 1 |
| Honeycombing Left Lung Zone 1 - Week 24: 26-50% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Week 24: 51-75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Week 24: >75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Baseline: Absent | 4 | 7 | 4 |
| Honeycombing Left Lung Zone 2 - Baseline: 1-25% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Week 24: Absent | 4 | 6 | 5 |
| Honeycombing Left Lung Zone 2 - Week 24: 1-25% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Week 24: 26-50% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Week 24: 51-75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Week 24: >75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Baseline: Absent | 4 | 5 | 4 |
| Honeycombing Left Lung Zone 3 - Baseline: 1-25% | 0 | 1 | 0 |
| Honeycombing Left Lung Zone 3 - Baseline: 26-50% | 0 | 1 | 0 |
| Honeycombing Left Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Baseline: >75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Week 24: Absent | 4 | 5 | 5 |
| Honeycombing Left Lung Zone 3 - Week 24: 1-25% | 0 | 1 | 0 |
| Honeycombing Left Lung Zone 3 - Week 24: 26-50% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Week 24: 51-75% | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Week 24: >75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Baseline: Absent | 4 | 7 | 4 |
| Honeycombing Right Lung Zone 1 - Baseline: 1-25% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Week 24: Absent | 4 | 6 | 5 |
| Honeycombing Right Lung Zone 1 - Week 24: 1-25% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Week 24: 26-50% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Week 24: 51-75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Week 24: >75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Baseline: Absent | 4 | 7 | 4 |
| Honeycombing Right Lung Zone 2 - Baseline: 1-25% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Week 24: Absent | 4 | 6 | 5 |
| Honeycombing Right Lung Zone 2 - Week 24: 1-25% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Week 24: 26-50% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Week 24: 51-75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Week 24: >75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Baseline: Absent | 4 | 5 | 4 |
| Honeycombing Right Lung Zone 3 - Baseline: 1-25% | 0 | 1 | 0 |
| Honeycombing Right Lung Zone 3 - Baseline: 26-50% | 0 | 1 | 0 |
| Honeycombing Right Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Baseline: >75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Week 24: Absent | 4 | 5 | 5 |
| Honeycombing Right Lung Zone 3 - Week 24: 1-25% | 0 | 1 | 0 |
| Honeycombing Right Lung Zone 3 - Week 24: 26-50% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Week 24: 51-75% | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Week 24: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: Absent | 3 | 6 | 4 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: 1-25% | 1 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 24: Absent | 3 | 6 | 5 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 24: 1-25% | 1 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 24: 26-50% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 24: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 24: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: Absent | 4 | 4 | 4 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: 1-25% | 0 | 3 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 24: Absent | 4 | 3 | 4 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 24: 1-25% | 0 | 3 | 1 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 24: 26-50% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 24: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 24: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: Absent | 4 | 1 | 2 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: 1-25% | 0 | 2 | 1 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: 26-50% | 0 | 2 | 1 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: 51-75% | 0 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: >75% | 0 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 24: Absent | 2 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 24: 1-25% | 2 | 3 | 4 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 24: 26-50% | 0 | 1 | 1 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 24: 51-75% | 0 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 24: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: Absent | 4 | 6 | 4 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: 1-25% | 0 | 1 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 24: Absent | 2 | 5 | 3 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 24: 1-25% | 2 | 1 | 2 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 24: 26-50% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 24: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 24: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: Absent | 4 | 3 | 3 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: 1-25% | 0 | 4 | 1 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 24: Absent | 4 | 4 | 3 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 24: 1-25% | 0 | 2 | 1 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 24: 26-50% | 0 | 0 | 1 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 24: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 24: >75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: Absent | 3 | 1 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: 1-25% | 1 | 2 | 2 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: 26-50% | 0 | 2 | 2 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: >75% | 0 | 2 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 24: Absent | 2 | 2 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 24: 1-25% | 2 | 2 | 3 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 24: 26-50% | 0 | 1 | 2 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 24: 51-75% | 0 | 1 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 24: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: Absent | 2 | 4 | 3 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: 1-25% | 2 | 3 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 24: Absent | 4 | 4 | 4 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 24: 1-25% | 0 | 2 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 24: 26-50% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 24: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 24: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: Absent | 3 | 4 | 3 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: 1-25% | 1 | 3 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 24: Absent | 4 | 3 | 4 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 24: 1-25% | 0 | 3 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 24: 26-50% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 24: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 24: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: Absent | 2 | 4 | 2 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: 1-25% | 1 | 3 | 2 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: 26-50% | 1 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 24: Absent | 2 | 2 | 2 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 24: 1-25% | 2 | 2 | 2 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 24: 26-50% | 0 | 1 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 24: 51-75% | 0 | 1 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 24: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: Absent | 3 | 4 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: 1-25% | 1 | 2 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: 26-50% | 0 | 1 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 24: Absent | 3 | 3 | 3 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 24: 1-25% | 1 | 2 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 24: 26-50% | 0 | 1 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 24: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 24: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: Absent | 3 | 5 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: 1-25% | 1 | 1 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: 26-50% | 0 | 1 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 24: Absent | 3 | 4 | 3 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 24: 1-25% | 1 | 2 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 24: 26-50% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 24: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 24: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: Absent | 2 | 3 | 1 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: 1-25% | 1 | 3 | 3 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: 26-50% | 1 | 1 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: >75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 24: Absent | 2 | 2 | 1 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 24: 1-25% | 2 | 3 | 4 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 24: 26-50% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 24: 51-75% | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 24: >75% | 0 | 1 | 0 |
Lung fibrosis is a lung disease in which lung tissue becomes damaged and scared. Lung fibrosis was assessed using HRCT. HRCT is a type of computed tomography used to diagnose and stage the severity. Pure ground-class opacity, pulmonary fibrosis and honeycombing were recorded for each lung (right and left) and three lung zones (upper, middle, and lower). They were recorded categorically for the amount detected, ranged as Absent, 1-25%, 26-50%, 51-75% and \>75% for abnormality/lung fibrosis. Number of participants with lung fibrosis at Baseline and Week 52 are reported in this outcome measure. In the data table below, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Participants | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Honeycombing Left Lung Zone 1 - Baseline: Absent | 4 | 2 | 6 | 2 |
| Honeycombing Left Lung Zone 1 - Baseline: 1-25% | 0 | 0 | 0 | 1 |
| Honeycombing Left Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Week 52: Absent | 4 | 2 | 3 | 3 |
| Honeycombing Left Lung Zone 1 - Week 52: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 1 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Baseline: Absent | 4 | 2 | 6 | 3 |
| Honeycombing Left Lung Zone 2 - Baseline: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Week 52: Absent | 4 | 2 | 3 | 3 |
| Honeycombing Left Lung Zone 2 - Week 52: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 2 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Baseline: Absent | 4 | 2 | 5 | 3 |
| Honeycombing Left Lung Zone 3 - Baseline: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Baseline: 26-50% | 0 | 0 | 1 | 0 |
| Honeycombing Left Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Week 52: Absent | 4 | 2 | 2 | 3 |
| Honeycombing Left Lung Zone 3 - Week 52: 1-25% | 0 | 0 | 1 | 0 |
| Honeycombing Left Lung Zone 3 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Left Lung Zone 3 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Baseline: Absent | 4 | 2 | 6 | 3 |
| Honeycombing Right Lung Zone 1 - Baseline: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Week 52: Absent | 4 | 2 | 3 | 3 |
| Honeycombing Right Lung Zone 1 - Week 52: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 1 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Baseline: Absent | 4 | 2 | 6 | 3 |
| Honeycombing Right Lung Zone 2 - Baseline: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Week 52: Absent | 4 | 2 | 3 | 3 |
| Honeycombing Right Lung Zone 2 - Week 52: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 2 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Baseline: Absent | 4 | 2 | 5 | 3 |
| Honeycombing Right Lung Zone 3 - Baseline: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Baseline: 26-50% | 0 | 0 | 1 | 0 |
| Honeycombing Right Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Week 52: Absent | 4 | 2 | 3 | 3 |
| Honeycombing Right Lung Zone 3 - Week 52: 1-25% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Honeycombing Right Lung Zone 3 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: Absent | 3 | 2 | 6 | 3 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: 1-25% | 1 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 52: Absent | 3 | 2 | 2 | 1 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 52: 1-25% | 1 | 0 | 1 | 2 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 1 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: Absent | 4 | 2 | 4 | 2 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: 1-25% | 0 | 0 | 2 | 1 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 52: Absent | 4 | 1 | 3 | 3 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 52: 1-25% | 0 | 1 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 2 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: Absent | 4 | 0 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: 1-25% | 0 | 2 | 2 | 2 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: 26-50% | 0 | 0 | 2 | 1 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Baseline: >75% | 0 | 0 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 52: Absent | 3 | 0 | 1 | 1 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 52: 1-25% | 1 | 1 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 52: 26-50% | 0 | 1 | 0 | 2 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 52: 51-75% | 0 | 0 | 1 | 0 |
| Pulmonary Fibrosis Left Lung Zone 3 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: Absent | 4 | 2 | 6 | 1 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: 1-25% | 0 | 0 | 0 | 2 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 52: Absent | 3 | 2 | 2 | 1 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 52: 1-25% | 1 | 0 | 1 | 2 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 1 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: Absent | 4 | 2 | 3 | 1 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: 1-25% | 0 | 0 | 3 | 1 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 | 1 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 52: Absent | 3 | 1 | 1 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 52: 1-25% | 1 | 1 | 2 | 2 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 52: 26-50% | 0 | 0 | 0 | 1 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 2 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: Absent | 3 | 0 | 1 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: 1-25% | 1 | 2 | 2 | 1 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: 26-50% | 0 | 0 | 2 | 2 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Baseline: >75% | 0 | 0 | 1 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 52: Absent | 2 | 0 | 1 | 1 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 52: 1-25% | 2 | 1 | 1 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 52: 26-50% | 0 | 0 | 1 | 2 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 52: 51-75% | 0 | 1 | 0 | 0 |
| Pulmonary Fibrosis Right Lung Zone 3 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: Absent | 2 | 2 | 3 | 2 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: 1-25% | 2 | 0 | 3 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 52: Absent | 4 | 1 | 3 | 2 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 52: 1-25% | 0 | 1 | 0 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 1 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: Absent | 3 | 2 | 4 | 2 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: 1-25% | 1 | 0 | 2 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 52: Absent | 4 | 2 | 2 | 2 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 52: 1-25% | 0 | 0 | 0 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 52: 26-50% | 0 | 0 | 1 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 2 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: Absent | 2 | 1 | 4 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: 1-25% | 1 | 1 | 2 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: 26-50% | 1 | 0 | 0 | 1 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 52: Absent | 1 | 1 | 1 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 52: 1-25% | 2 | 1 | 2 | 3 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 52: 26-50% | 1 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Left Lung Zone 3 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: Absent | 3 | 1 | 3 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: 1-25% | 1 | 1 | 2 | 1 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: 26-50% | 0 | 0 | 1 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 52: Absent | 3 | 2 | 3 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 52: 1-25% | 1 | 0 | 0 | 3 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 1 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: Absent | 3 | 2 | 4 | 1 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: 1-25% | 1 | 0 | 1 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: 26-50% | 0 | 0 | 1 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 52: Absent | 1 | 1 | 2 | 1 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 52: 1-25% | 3 | 1 | 1 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 52: 26-50% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 2 - Week 52: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: Absent | 2 | 1 | 3 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: 1-25% | 1 | 1 | 2 | 3 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: 26-50% | 1 | 0 | 1 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Baseline: >75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 52: Absent | 2 | 1 | 2 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 52: 1-25% | 1 | 0 | 1 | 2 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 52: 26-50% | 1 | 1 | 0 | 1 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 52: 51-75% | 0 | 0 | 0 | 0 |
| Pure Ground-Glass Opacity Right Lung Zone 3 - Week 52: >75% | 0 | 0 | 0 | 0 |
Plasma concentration of belumosudil and its metabolite (KD025m2) at pre-dose and 3 hours post-dose at Week 4 and 8 is reported in this outcome measure. The Lower Limit of Quantification (LLOQ) was 10 nanograms per milliliter (ng/mL).
| ng/mL | DB Period: Belumosudil QD | DB Period: Belumosudil BID |
|---|---|---|
| Belumosudil: Pre-dose at Week 4 | 162.68 ± 215.574 | 837.75 ± 874.185 |
| Belumosudil: 3 hours Post-dose at Week 4 | 1081.56 ± 1093.259 | 1824.60 ± 1216.098 |
| Belumosudil: Pre-dose at Week 8 | 90.74 ± 94.665 | 613.67 ± 387.507 |
| Belumosudil: 3 hours Post-dose at Week 8 | 1367.60 ± 1148.820 | 1528.33 ± 1026.514 |
| KD025m2: Pre-dose at Week 4 | 18.81 ± 24.451 | 71.57 ± 89.009 |
| KD025m2: 3 hours Post-dose at Week 4 | 131.62 ± 235.429 | 166.36 ± 175.126 |
| KD025m2: Pre-dose at Week 8 | 5.53 ± 9.461 | 60.47 ± 44.930 |
| KD025m2: 3 hours Post-dose at Week 8 | 189.23 ± 295.346 | 139.78 ± 146.559 |
Adverse event (AE): any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs: AEs with onset after the first dose of study drug or existing AEs that worsened during TEAE Period (for DB period: From Day 1 (Week 0) up to Week 28; for OLE period: from Week 29 up to 4 weeks post last study drug administration).
| Participants | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|---|---|---|
| TEAEs | 11 | 11 | 11 | 9 | 5 | 9 | 5 |
| TESAEs | 2 | 0 | 3 | 0 | 0 | 1 | 0 |
Vital signs (systolic and diastolic blood pressure) were measured with the participants after having rested in sitting position. Vital signs assessments were performed before the electrocardiogram (ECG) and other scheduled assessments. Change from Baseline in systolic and diastolic blood pressure at Week 24 was reported in this outcome measure.
| millimeters of mercury | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Systolic blood pressure | 1.9 ± 15.13 | 3.9 ± 10.60 | 2.2 ± 8.72 |
| Diastolic blood pressure | -0.9 ± 10.52 | 7.1 ± 8.95 | -0.5 ± 7.27 |
Change from Baseline in systolic and diastolic blood pressure at Week 52 was reported in this outcome measure. Vital signs (systolic and diastolic blood pressure) were measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other schedules assessments. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| millimeters of mercury | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Systolic blood pressure | -2.4 ± 16.30 | -1.2 ± 15.30 | 5.0 ± 16.41 | -9.5 ± 19.61 |
| Diastolic blood pressure | -4.3 ± 8.06 | 0.6 ± 12.74 | 4.9 ± 9.17 | -6.2 ± 17.43 |
Vital sign (pulse) was measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other scheduled assessments. Change from Baseline in vital signs: pulse at Week 24 was reported in this outcome measure.
| beats per minute | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Vital Signs: Pulse at Week 24 | -3.1 ± 9.49 | -2.8 ± 13.00 | -2.0 ± 7.46 |
Vital sign (pulse) was measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other scheduled assessments. Change from Baseline in vital signs: pulse at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| beats per minute | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Vital Signs: Pulse at Week 52 | -5.9 ± 6.47 | -1.6 ± 4.39 | 1.3 ± 13.73 | -12.2 ± 34.37 |
Vital sign (respiratory rate) was measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other scheduled assessments. Change from Baseline in vital signs: respiratory rate at Week 24 was reported in this outcome measure.
| breaths per minute | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Vital Signs: Respiratory Rate at Week 24 | 1.4 ± 3.41 | 0.1 ± 2.13 | 0.6 ± 1.86 |
Vital sign (respiratory rate) was measured with the participants after having rested in sitting position. Vital signs assessments were performed before ECGs and other scheduled assessments. Change from Baseline in vital signs: respiratory rate at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| breaths per minute | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Vital Signs: Respiratory Rate at Week 52 | 0.0 ± 2.31 | 1.4 ± 1.52 | 0.3 ± 1.86 | 0.0 ± 2.10 |
ECGs were recorded after the participant had rested in the supine position for at least 5 minutes and were performed prior to any blood sample collection. Change from Baseline in 12-lead ECG values: heart rate at Week 24 was reported in this outcome measure.
| beats per minute | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in 12-lead Electrocardiogram (ECG) Values: Heart Rate at Week 24 | -3.6 ± 8.71 | -2.1 ± 3.57 | -5.5 ± 10.52 |
ECGs were recorded after the participant had rested in the supine position for at least 5 minutes and were performed prior to any blood sample collection. Change from Baseline in 12-lead ECG values: heart rate at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| beats per minute | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in 12-lead Electrocardiogram Values: Heart Rate at Week 52 | -3.6 ± 10.83 | 1.0 ± 6.52 | -0.7 ± 10.88 | -13.8 ± 24.13 |
ECGs were recorded after the participant had rested in the supine position for at least 5 minutes and were performed prior to any blood sample collection. Change from Baseline in 12-lead ECG values: PR interval, RR interval, QRS interval, QT interval and QTcF interval at Week 24 was reported in this outcome measure.
| millisecond | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| PR Interval | 2.4 ± 10.96 | 1.6 ± 9.74 | -1.4 ± 7.58 |
| RR Interval | 46.1 ± 114.87 | 18.0 ± 39.71 | 47.2 ± 110.91 |
| QRS Interval | 0.8 ± 6.55 | 0.6 ± 3.89 | -0.5 ± 8.71 |
| QT Interval | 8.9 ± 16.87 | 7.5 ± 14.84 | 12.4 ± 23.64 |
| QTcF Interval | 2.433 ± 12.039 | 5.008 ± 12.560 | 4.766 ± 14.177 |
ECGs were recorded after the participant had rested in the supine position for at least 5 minutes and were performed prior to any blood sample collection. Change from Baseline in 12-lead ECG values: PR interval, RR interval, QRS interval, QT interval and QTcF interval at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| millisecond | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| PR Interval | 6.2 ± 8.92 | 1.6 ± 9.63 | 6.5 ± 11.66 | 7.5 ± 10.99 |
| RR Interval | 40.3 ± 120.90 | -25.2 ± 93.73 | 18.5 ± 153.16 | 145.2 ± 251.04 |
| QRS Interval | -0.2 ± 8.51 | 4.2 ± 6.83 | 0.5 ± 6.25 | -1.2 ± 4.31 |
| QT Interval | 6.3 ± 16.76 | -0.4 ± 14.77 | 2.2 ± 22.33 | 27.5 ± 53.48 |
| QTcF Interval | 0.056 ± 12.791 | 3.080 ± 14.850 | 0.108 ± 13.310 | 3.873 ± 17.489 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameters: percentage of basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes at Week 24 was reported in this outcome measure.
| percentage of white blood cells | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Basophils/Leukocytes | 0.00 ± 0.340 | 0.26 ± 0.575 | 0.04 ± 0.273 |
| Eosinophils/Leukocytes | 0.02 ± 0.745 | -0.07 ± 1.203 | 0.50 ± 1.001 |
| Lymphocytes/Leukocytes | -0.61 ± 3.618 | 3.29 ± 4.418 | 1.89 ± 7.214 |
| Monocytes/Leukocytes | -0.61 ± 1.024 | -0.41 ± 2.153 | 0.22 ± 1.455 |
| Neutrophils/Leukocytes | 1.24 ± 4.255 | -1.04 ± 8.411 | -2.60 ± 8.110 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameters: percentage of basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| percentage of white blood cells | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Basophils/Leukocytes | 0.29 ± 0.341 | -0.06 ± 0.336 | 0.79 ± 0.934 | 0.00 ± 0.303 |
| Eosinophils/Leukocytes | -0.05 ± 0.721 | 0.32 ± 0.694 | 0.36 ± 3.233 | 0.65 ± 0.737 |
| Lymphocytes/Leukocytes | -1.18 ± 4.996 | -0.02 ± 6.823 | 5.80 ± 6.817 | 1.87 ± 6.490 |
| Monocytes/Leukocytes | -0.22 ± 1.211 | -0.20 ± 0.797 | 0.46 ± 1.577 | -0.75 ± 2.449 |
| Neutrophils/Leukocytes | 1.18 ± 5.401 | 0.02 ± 5.513 | -4.77 ± 7.592 | -1.75 ± 7.900 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter (hematocrit, fraction of 1.0) at Week 24 was reported in this outcome measure. The hematocrit is percentage of the volume of whole blood that is made up of red blood cells.
| percentage of red blood cells in blood | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Hematological Parameter: Hematocrit at Week 24 | 0.002 ± 0.027 | 0.003 ± 0.040 | 0.012 ± 0.067 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter (hematocrit, fraction of 1.0) at Week 52 was reported in this outcome measure. The hematocrit is percentage of the volume of whole blood that is made up of red blood cells. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| percentage of red blood cells in blood | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Hematological Parameter: Hematocrit at Week 52 | -0.004 ± 0.033 | -0.024 ± 0.042 | -0.003 ± 0.023 | -0.032 ± 0.026 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: hemoglobin at Week 24 was reported in this outcome measure.
| grams per liter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Hematological Parameter: Hemoglobin at Week 24 | 1.2 ± 7.39 | -3.6 ± 14.77 | 2.6 ± 19.96 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: hemoglobin at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| grams per liter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Hematological Parameter: Hemoglobin at Week 52 | -2.4 ± 8.45 | -2.8 ± 12.01 | 0.4 ± 6.70 | -8.0 ± 10.49 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: erythrocytes mean corpuscular volume at Week 24 was reported in this outcome measure.
| femtoliters | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Hematological Parameter: Erythrocytes Mean Corpuscular Volume at Week 24 | -0.7 ± 2.00 | 2.2 ± 3.15 | 0.5 ± 2.70 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: erythrocytes mean corpuscular volume at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| femtoliters | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Hematological Parameter: Erythrocytes Mean Corpuscular Volume at Week 52 | -0.2 ± 2.20 | -0.6 ± 1.34 | 0.7 ± 2.56 | -3.3 ± 4.03 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: platelets at Week 24 was reported in this outcome measure.
| 10^9 cells per liter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Hematological Parameter: Platelets at Week 24 | -2.8 ± 69.88 | -29.3 ± 56.97 | -28.1 ± 64.79 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: platelets at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| 10^9 cells per liter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Hematological Parameter: Platelets at Week 52 | -5.9 ± 59.12 | -25.6 ± 65.23 | -31.3 ± 62.38 | 60.7 ± 95.98 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: erythrocytes at Week 24 was reported in this outcome measure.
| 10^12 cells per liter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Hematological Parameter: Erythrocytes at Week 24 | 0.05 ± 0.331 | -0.07 ± 0.480 | 0.12 ± 0.666 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: erythrocytes at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| 10^12 cells per liter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Hematological Parameter: Erythrocytes at Week 52 | -0.06 ± 0.337 | -0.18 ± 0.409 | -0.09 ± 0.227 | -0.17 ± 0.163 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: leukocytes at Week 24 was reported in this outcome measure.
| 10^9 cells per liter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Hematological Parameter: Leukocytes at Week 24 | -0.579 ± 1.030 | -0.673 ± 2.427 | -0.124 ± 1.310 |
Blood samples were collected at specified timepoints to assess hematological parameters. Change from Baseline in hematological parameter: leukocytes at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| 10^9 cells per liter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Hematological Parameter: Leukocytes at Week 52 | -0.255 ± 1.519 | -0.386 ± 0.198 | -2.281 ± 4.379 | -1.015 ± 1.382 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: albumin, globulin and protein at Week 24 was reported in this outcome measure.
| grams per liter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Albumin | -0.3 ± 1.83 | 0.1 ± 2.42 | -0.9 ± 2.39 |
| Globulin | -1.5 ± 1.43 | 0.0 ± 2.71 | -2.7 ± 10.20 |
| Protein | -1.8 ± 3.05 | 0.1 ± 3.75 | -3.6 ± 9.07 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: albumin, globulin and protein at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| grams per liter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Albumin | -1.3 ± 3.20 | -1.0 ± 2.65 | 0.0 ± 3.06 | -0.8 ± 2.14 |
| Globulin | -3.4 ± 2.83 | -0.8 ± 1.92 | 0.0 ± 2.83 | 0.5 ± 5.68 |
| Protein | -4.8 ± 4.68 | -1.8 ± 2.49 | 0.0 ± 4.90 | -0.3 ± 4.50 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, and lactate dehydrogenase at Week 24 was reported in this outcome measure.
| units per liter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Alkaline Phosphatase | -1.7 ± 14.46 | 1.3 ± 7.76 | 4.1 ± 9.31 |
| Alanine Aminotransferase | 1.9 ± 7.87 | -6.9 ± 16.84 | 0.4 ± 13.51 |
| Aspartate Aminotransferase | 0.6 ± 5.17 | -6.9 ± 18.18 | 0.1 ± 7.48 |
| Creatine Kinase | 16.9 ± 124.46 | -15.6 ± 83.11 | -1.7 ± 29.99 |
| Gamma Glutamyl Transferase | 0.1 ± 7.67 | -0.8 ± 8.72 | 1.1 ± 6.99 |
| Lactate Dehydrogenase | 6.9 ± 33.88 | -19.0 ± 28.33 | 6.7 ± 14.52 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, and lactate dehydrogenase at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| units per liter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Alkaline Phosphatase | 0.9 ± 18.00 | -4.2 ± 9.23 | 2.3 ± 12.57 | 7.5 ± 17.06 |
| Alanine Aminotransferase | 5.0 ± 11.93 | 2.2 ± 2.17 | -5.0 ± 18.41 | 1.2 ± 5.04 |
| Aspartate Aminotransferase | 3.2 ± 9.83 | 0.4 ± 2.30 | -3.9 ± 22.41 | -3.5 ± 3.51 |
| Creatine Kinase | 10.0 ± 79.24 | 26.6 ± 42.34 | 16.7 ± 92.29 | -16.2 ± 20.01 |
| Gamma Glutamyl Transferase | 0.7 ± 5.61 | -0.8 ± 1.30 | -6.1 ± 14.09 | -1.2 ± 9.97 |
| Lactate Dehydrogenase | 4.3 ± 51.53 | -8.8 ± 20.66 | -13.5 ± 37.95 | -39.8 ± 73.03 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: bicarbonate, blood urea nitrogen, calcium, chloride, glucose, potassium, magnesium, phosphate and sodium at Week 24 was reported in this outcome measure.
| millimoles per liter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Bicarbonate | -1.83 ± 2.058 | 0.42 ± 0.935 | 0.48 ± 1.946 |
| Blood Urea Nitrogen | -0.011 ± 0.163 | -0.086 ± 0.224 | 0.005 ± 0.163 |
| Calcium | -0.022 ± 0.102 | 0.005 ± 0.068 | -0.033 ± 0.059 |
| Chloride | -0.4 ± 2.32 | -0.3 ± 1.64 | 1.2 ± 1.40 |
| Glucose | -0.304 ± 1.260 | -0.767 ± 1.236 | -0.219 ± 1.016 |
| Potassium | -0.11 ± 0.555 | 0.04 ± 0.388 | -0.04 ± 0.229 |
| Magnesium | -0.005 ± 0.071 | -0.011 ± 0.055 | 0.000 ± 0.053 |
| Phosphate | -0.113 ± 0.167 | 0.076 ± 0.093 | -0.085 ± 0.127 |
| Sodium | -1.4 ± 2.01 | 0.7 ± 1.57 | 0.5 ± 1.44 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: bicarbonate, blood urea nitrogen, calcium, chloride, glucose, potassium, magnesium, phosphate and sodium at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| millimoles per liter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Bicarbonate | -1.60 ± 1.572 | 1.90 ± 1.414 | 0.63 ± 3.256 | 0.53 ± 1.998 |
| Blood Urea Nitrogen | -0.008 ± 0.127 | 0.094 ± 0.206 | -0.026 ± 0.130 | -0.030 ± 0.139 |
| Calcium | -0.074 ± 0.082 | -0.010 ± 0.065 | -0.006 ± 0.128 | -0.027 ± 0.080 |
| Chloride | 0.4 ± 1.81 | -1.4 ± 2.07 | 1.4 ± 2.88 | -0.7 ± 1.03 |
| Glucose | -0.147 ± 1.080 | 0.612 ± 1.063 | -0.319 ± 0.700 | 0.092 ± 1.330 |
| Potassium | -0.18 ± 0.441 | 0.00 ± 0.469 | 0.01 ± 0.518 | -0.23 ± 0.273 |
| Magnesium | -0.028 ± 0.079 | -0.058 ± 0.025 | -0.013 ± 0.045 | -0.007 ± 0.030 |
| Phosphate | -0.108 ± 0.137 | 0.016 ± 0.116 | 0.124 ± 0.126 | 0.037 ± 0.086 |
| Sodium | -1.1 ± 2.62 | 0.2 ± 0.45 | 1.3 ± 2.56 | -1.3 ± 1.03 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: direct bilirubin, bilirubin, creatinine and urate at Week 24 was reported in this outcome measure.
| micromole per liter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| Direct Bilirubin | 0.171 ± 0.541 | -0.214 ± 0.996 | -0.233 ± 0.553 |
| Bilirubin | 1.026 ± 2.308 | 1.368 ± 2.251 | -0.466 ± 2.767 |
| Creatinine | 3.536 ± 7.455 | 2.652 ± 14.466 | -3.215 ± 9.078 |
| Urate | -4.760 ± 44.860 | -6.545 ± 31.164 | 4.868 ± 43.383 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: direct bilirubin, bilirubin, creatinine and urate at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| micromole per liter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| Direct Bilirubin | 0.285 ± 0.605 | -0.171 ± 0.382 | -0.489 ± 0.969 | -0.428 ± 1.047 |
| Bilirubin | 0.950 ± 2.280 | -1.026 ± 0.937 | 0.489 ± 2.144 | 0.285 ± 2.517 |
| Creatinine | 8.840 ± 9.883 | 8.840 ± 6.251 | 2.526 ± 9.836 | 0.000 ± 5.591 |
| Urate | 2.644 ± 41.768 | 2.380 ± 14.934 | 6.800 ± 45.109 | -15.867 ± 47.102 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: calcium corrected at Week 24 was reported in this outcome measure.
| milligrams per deciliter | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Clinical Chemistry Parameter: Calcium Corrected at Week 24 | -0.06 ± 0.303 | 0.00 ± 0.249 | -0.05 ± 0.211 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: calcium corrected at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| milligrams per deciliter | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Clinical Chemistry Parameter: Calcium Corrected at Week 52 | -0.18 ± 0.222 | 0.08 ± 0.192 | -0.03 ± 0.454 | -0.05 ± 0.373 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: glomerular filtration rate at Week 24 was reported in this outcome measure. Expanded unit of measure is milliliter per minute per 1.73 square meters.
| mL/min/1.73 m^2 | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo |
|---|---|---|---|
| DB Period: Change From Baseline in Clinical Chemistry Parameter: Glomerular Filtration Rate at Week 24 | -4.76 ± 11.414 | -6.88 ± 11.749 | 3.36 ± 10.229 |
Blood samples were collected at specified timepoints to assess clinical chemistry parameters. Change from Baseline in clinical chemistry parameter: glomerular filtration rate at Week 52 was reported in this outcome measure. Participants who received placebo in DB period and re-randomized into OLE period, OLE period Baseline was defined as valid and last non-missing value obtained prior to participant receiving first dose of belumosudil in OLE period. Participants who received belumosudil in DB period and continued belumosudil in OLE period, Baseline value was defined as valid and last non-missing value obtained within 29 days prior to participant receiving first study medication in DB period.
| mL/min/1.73 m^2 | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|
| OLE Period: Change From Baseline in Clinical Chemistry Parameter: Glomerular Filtration Rate at Week 52 | -26.60 | -16.40 | -0.40 | -9.70 ± 13.152 |
Collected over For DB period: From Day 1 (Week 0) up to Week 28; for OLE period: from Week 29 up to 4 weeks post last study drug administration (i.e., up to Week 56). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB Period: Belumosudil QD | 0/11 (0%) | 2/11 (18.2%) | 10/11 (90.9%) |
| DB Period: Belumosudil BID | 0/12 (0%) | 0/12 (0%) | 11/12 (91.7%) |
| DB Period: Placebo | 0/12 (0%) | 3/12 (25%) | 11/12 (91.7%) |
| OLE Period: Belumosudil QD | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| OLE Period: Placebo/Belumosudil QD | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| OLE Period: Belumosudil BID | 0/10 (0%) | 1/10 (10%) | 9/10 (90%) |
| OLE Period: Placebo/Belumosudil BID | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Event | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|---|---|---|
| Cardiac Failure CongestiveCardiac disorders | 0/11 | 0/12 | 0/12 | 0/10 | 0/5 | 1/10 | 0/6 |
| Pneumonia AspirationRespiratory, thoracic and mediastinal disorders | 0/11 | 0/12 | 0/12 | 0/10 | 0/5 | 1/10 | 0/6 |
| Covid-19Infections and infestations | 1/11 | 0/12 | 0/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| Flank PainMusculoskeletal and connective tissue disorders | 1/11 | 0/12 | 0/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| AnaemiaBlood and lymphatic system disorders | 0/11 | 0/12 | 1/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| Atrial FlutterCardiac disorders | 0/11 | 0/12 | 1/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| Scleroderma Renal CrisisRenal and urinary disorders | 0/11 | 0/12 | 1/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| Pulmonary OedemaRespiratory, thoracic and mediastinal disorders | 0/11 | 0/12 | 1/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| Deep Vein ThrombosisVascular disorders | 0/11 | 0/12 | 1/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| Event | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | OLE Period: Belumosudil QD | OLE Period: Placebo/Belumosudil QD | OLE Period: Belumosudil BID | OLE Period: Placebo/Belumosudil BID |
|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 2/11 | 0/12 | 7/12 | 1/10 | 1/5 | 0/10 | 0/6 |
| NauseaGastrointestinal disorders | 4/11 | 0/12 | 5/12 | 0/10 | 2/5 | 0/10 | 1/6 |
| DiarrhoeaGastrointestinal disorders | 4/11 | 1/12 | 2/12 | 1/10 | 2/5 | 1/10 | 1/6 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/11 | 0/12 | 1/12 | 0/10 | 0/5 | 0/10 | 2/6 |
| PruritusSkin and subcutaneous tissue disorders | 3/11 | 0/12 | 3/12 | 1/10 | 0/5 | 0/10 | 0/6 |
| ConstipationGastrointestinal disorders | 0/11 | 0/12 | 3/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| Raynaud's PhenomenonVascular disorders | 0/11 | 0/12 | 3/12 | 0/10 | 0/5 | 0/10 | 0/6 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/11 | 0/12 | 1/12 | 0/10 | 1/5 | 0/10 | 0/6 |
| ArrhythmiaCardiac disorders | 0/11 | 0/12 | 0/12 | 0/10 | 1/5 | 0/10 | 0/6 |
| VertigoEar and labyrinth disorders | 0/11 | 0/12 | 0/12 | 0/10 | 1/5 | 0/10 | 0/6 |
Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least one dose of the study drug.
| Age, Continuous(years) | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | Total |
|---|---|---|---|---|
| Mean | 52.7 ± 11.99 | 49.7 ± 15.80 | 46.3 ± 10.64 | 49.5 ± 12.91 |
| Sex: Female, Male(Participants) | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | Total |
|---|---|---|---|---|
| Female | 7 | 9 | 10 | 26 |
| Male | 4 | 3 | 2 | 9 |
| Race (NIH/OMB)(Participants) | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 0 | 4 |
| White | 8 | 8 | 11 | 27 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 | 2 |
| Modified Rodnan Skin Score (mRSS)(score on a scale) | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | Total |
|---|---|---|---|---|
| Mean | 26.5 ± 6.47 | 25.2 ± 5.29 | 23.1 ± 4.85 | 24.9 ± 5.57 |
| Percent predicted forced vital capacity (FVC)(percent predicted FVC) | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | Total |
|---|---|---|---|---|
| Mean | 98.6 ± 15.91 | 84.0 ± 15.90 | 86.2 ± 17.75 | 89.3 ± 17.32 |
| Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score(score on a scale) | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | Total |
|---|---|---|---|---|
| Mean | 43.1 ± 17.89 | 58.2 ± 12.59 | 43.0 ± 18.06 | 48.2 ± 17.43 |
| Patient Global Assessment of Participant's Overall Health Using VAS Score(score on a scale) | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | Total |
|---|---|---|---|---|
| Mean | 56.5 ± 22.47 | 58.6 ± 16.92 | 59.6 ± 16.72 | 58.3 ± 18.26 |
| Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score(score on a scale) | DB Period: Belumosudil QD | DB Period: Belumosudil BID | DB Period: Placebo | Total |
|---|---|---|---|---|
| Mean | 1.489 ± 0.719 | 1.396 ± 0.626 | 1.302 ± 0.712 | 1.393 ± 0.670 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Jun 2019 to primary completion in Aug 2022, 37 months.
Results were first posted in Aug 2023, 1 year after primary completion.
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Studies of the drug tested here: Belumosudil