Trial Outcomes & Findings for Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213 (NCT NCT05305989)

Last Updated: 2025-05-02

Results Overview

DOR is defined as time from first documentation of response to time of first documentation of deterioration from best response (e.g., complete response \[CR\] to partial response \[PR\], or PR to Lack of response \[LR\]). As per the 2014 National Institutes of Health (NIH) Consensus Development Project for clinical trials in cGVHD criteria: CR was defined as resolution of all manifestations of cGVHD in each organ or site.PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site.LR included response status of mixed, unchanged, or progression.Mixed LR was defined as complete or partial response in at least 1 organ accompanied by progression in another organ. Unchanged LR was defined as outcomes that did not meet criteria for CR, PR, progression or mixed response. Progression LR was defined as progression in at least 1 organ or site without a response in any other organ or site. Confidence interval (CI) is calculated using Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

Results posted on

2025-05-02

Participant Flow

This study was conducted at 8 sites in the United States from 23-Feb-2022 to 06-Jun-2024.

A total of 23 participants with chronic graft-versus-host-disease (cGVHD) who were previously treated with belumosudil in study KD025-208 (NCT02841995) or study KD025-213 (NCT03640481) were enrolled in this study.

Participant milestones

Participant milestones
Measure	Belumosudil 200 mg QD Participants received belumosudil 200 milligrams (mg) tablet orally once a day (QD) until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID Participants received belumosudil 200 mg tablet orally twice a day (BID) until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Overall Study STARTED	13	9	1
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	13	9	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Belumosudil 200 mg QD Participants received belumosudil 200 milligrams (mg) tablet orally once a day (QD) until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID Participants received belumosudil 200 mg tablet orally twice a day (BID) until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Overall Study Other	3	2	0
Overall Study Sponsor decision	2	1	0
Overall Study Protocol Violation	0	1	0
Overall Study Investigator decision	1	2	0
Overall Study Progression of cGVHD (progression requiring addition of new systemic therapy for cGVHD)	3	0	0
Overall Study Adverse Event	1	1	0
Overall Study Enrolled but never dosed	3	2	1

Baseline Characteristics

Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belumosudil 200 mg QD n=13 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Total n=23 Participants Total of all reporting groups
Age, Customized 24-74 years	13 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized White or Caucasian	12 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

Population: Responder population included participants in the full analysis set that achieved a partial or complete response at any post-baseline response assessment. Only those participants who achieved CR or PR are reported.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=8 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=8 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Duration of Response (DOR)	NA months Interval 5.55 to NA indicates that median and upper limit of confidence interval (CI) were not estimable due to insufficient number of participants with events at study closure.	NA months Interval 5.78 to NA indicates that median and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.	—

PRIMARY outcome

Timeframe: Baseline (Day 1) up to 23 months

Population: The full analysis set included all participants enrolled in the study.

The questionnaire asked participants to indicate the degree of bother that they experienced due to symptoms in 7 domains potentially affected by cGVHD. It consists of 30 items of 7 domains: skin, eyes and mouth, breathing, eating and digestion, muscles and joints, energy, and mental and emotional. Each question was rated/scored as 0-not at all, 1-slightly, 2-moderately, 3-quite a bit, 4-extremely with lower values representing better outcome. A domain score was calculated for each domain by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing, ranged from 0-100. A higher score indicated more bothersome symptoms. A 7-point difference on the total score of cGVHD symptom scale was found to be clinically meaningful.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=13 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Number of Participants With a >=7 Point Reduction (7PtR) From Baseline and >=7 Point Reduction From Baseline on 2 Consecutive Post-Baseline Assessments as Assessed by Lee Symptom Scale (LSS) >=7PtR From Baseline	8 Participants	2 Participants	0 Participants
Number of Participants With a >=7 Point Reduction (7PtR) From Baseline and >=7 Point Reduction From Baseline on 2 Consecutive Post-Baseline Assessments as Assessed by Lee Symptom Scale (LSS) >=7PtR From Baseline on 2 Consecutive Post-Baseline Assessment	8 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to 23 months

Population: The full analysis set included all participants enrolled in the study. Only those participants with \>=7PtR from Baseline are included in the analysis.

The questionnaire asked participants to indicate the degree of bother that they experienced due to symptoms in 7 domains potentially affected by cGVHD. It consisted of 30 items of 7 domains: skin, eyes and mouth, breathing, eating and digestion, muscles and joints, energy, and mental and emotional. Each question was rated/scored as 0-not at all, 1-slightly, 2-moderately, 3-quite a bit, 4-extremely with lower values representing better outcome. A domain score was calculated for each domain by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing, ranged from 0-100. A higher score indicated more bothersome symptoms. A 7-point difference on the total score of cGVHD symptom scale was found to be clinically meaningful. Mean of duration of \>=7PtR is presented.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=8 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=2 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale	67.2 weeks Standard Deviation 26.8	49.5 weeks Standard Deviation 54.2	—

PRIMARY outcome

Timeframe: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

Population: The full analysis set included all participants enrolled in the study.

The TTNT was measured as the time from first treatment to the time of new systemic cGVHD treatment, censored by last response assessment or long term follow up assessment, whichever was the latest and available. TTNT was analyzed by the Kaplan-Meier survival method.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=13 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Time to Next Treatment (TTNT)	NA months NA indicates that median, lower and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.	NA months Interval 5.14 to NA indicates that median and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.	NA months NA indicates that median, lower and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.

PRIMARY outcome

Timeframe: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

Population: The full analysis set included all participants enrolled in the study.

FFS was defined as the absence of new cGVHD systemic therapy, non-relapse mortality and recurrent malignancy (i.e. underlying disease) and was censored by last response assessment or long term follow up assessment, whichever was the latest and available. Kaplan-Meier method was used for the analysis.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=13 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Failure-Free Survival (FFS)	NA months NA indicates that median, lower and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.	NA months Interval 8.8 to NA indicates that median and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.	NA months NA indicates that median, lower and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.

PRIMARY outcome

Timeframe: From first dose of study drug (Day 1) to the date of death due to any cause, up to approximately 24 months

Population: The full analysis set included all participants enrolled in the study.

OS was defined as time from first dose of belumosudil to the date of death due to any cause. CI was calculated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=13 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Overall Survival (OS)	NA months NA indicates that median, lower and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.	NA months NA indicates that median, lower and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.	NA months NA indicates that median, lower and upper limit of CI were not estimable due to insufficient number of participants with events at study closure.

PRIMARY outcome

Timeframe: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

Population: The full analysis set included all participants enrolled in the study.

As per the 2014 NIH Consensus Development Project for clinical trials in cGVHD criteria: CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=13 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Percentage of Participants With Complete Response (CR) and Partial Response (PR) CR	30.8 percentage of participants	11.1 percentage of participants	0 percentage of participants
Percentage of Participants With Complete Response (CR) and Partial Response (PR) PR	30.8 percentage of participants	77.8 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

Population: The full analysis set included all participants enrolled in the study. Only those participants with data collected for each specified category are reported.

The best response (CR, PR) for individual organs (skin, eyes, mouth, esophagus, upper gastrointestinal \[GI\], lower GI, liver, lungs, joints and fascia) was summarized. As per the 2014 NIH Consensus Development Project for clinical trials in cGVHD criteria, CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=10 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=8 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Number of Participants With Best Response by Organ System Skin	6 Participants	5 Participants	0 Participants
Number of Participants With Best Response by Organ System Eyes	6 Participants	4 Participants	0 Participants
Number of Participants With Best Response by Organ System Mouth	4 Participants	3 Participants	0 Participants
Number of Participants With Best Response by Organ System Esophagus	1 Participants	2 Participants	0 Participants
Number of Participants With Best Response by Organ System Upper GI	0 Participants	0 Participants	0 Participants
Number of Participants With Best Response by Organ System Lower GI	0 Participants	1 Participants	0 Participants
Number of Participants With Best Response by Organ System Liver	1 Participants	0 Participants	0 Participants
Number of Participants With Best Response by Organ System Lungs	1 Participants	3 Participants	0 Participants
Number of Participants With Best Response by Organ System Joints and Fascia	5 Participants	7 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Month 23

Population: The full analysis set included all participants enrolled in the study. Only those participants with data collected at specified timepoints are reported.

Change in corticosteroid doses was analyzed by using prednisone dose equivalents. If participants were not using prednisone as the systemic corticosteroid, then the prednisone dose equivalent would be determined according to following conversion ratios: 1 mg prednisone is equivalent to: 4.0 mg Hydrocortisone; 0.8 mg Methylprednisolone; 0.15 mg Dexamethasone; 1.0 mg Prednisolone and 0.8 mg Triamcinolone. Baseline was defined as the valid and last non-missing value obtained within 28 days prior to participant receiving the first study drug in parent study (KD025-208 \[NCT02841995\] or KD025-213 \[NCT03640481\]).

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=4 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=2 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction	-50.00 percent change Interval -100.0 to 0.0	0.0 percent change Interval 0.0 to 0.0	—

PRIMARY outcome

Timeframe: From Baseline (Day 1) up to 23 months

Population: The full analysis set included all participants enrolled in the study. Only those categories in which at least 1 participant had data are reported.

The GSR assessment was performed by asking the participants to rate their disease severity of cGVHD symptoms on a 0 to 10-point numeric rating scale, where score 0 indicated 'not at all severe cGVHD symptoms' and score 10 indicated 'most severe cGVHD symptoms possible'. The response was defined using scores from 9 organs: skin, eyes, mouth, esophagus, upper GI track, lower GI tract, liver, lungs, and joints and fascia plus GSR. Baseline was defined as the valid and last non-missing value obtained within 28 days prior to participant receiving the first study drug in parent study (KD025-208 \[NCT02841995\] or KD025-213 \[NCT03640481\]). Maximal improvement from Baseline was calculated as lowest GSR score on scheduled visits minus GSR score at Baseline with possible ranges from -10 to 10. The lower the number means the better improvement in cGVHD symptoms.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=13 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment 0	1 Participants	0 Participants	0 Participants
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment -8	1 Participants	1 Participants	0 Participants
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment -7	0 Participants	1 Participants	0 Participants
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment -6	3 Participants	0 Participants	0 Participants
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment -5	2 Participants	2 Participants	0 Participants
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment -4	0 Participants	1 Participants	0 Participants
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment -3	1 Participants	1 Participants	0 Participants
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment -2	1 Participants	1 Participants	0 Participants
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment -1	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months

Population: The full analysis set included all participants enrolled in the study.

An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant associated with the use of a study drug, whether or not considered drug-related. 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 incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. The severity of each AE was graded using the Common Terminology Criteria for Adverse Events version 4.03 scale. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.

Outcome measures

Outcome measures
Measure	Belumosudil 200 mg QD n=13 Participants Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 Participants Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 Participants Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths TEAEs	8 Participants	7 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths TESAEs	4 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths Grade >=3 TEAEs	3 Participants	4 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths Deaths	0 Participants	0 Participants	0 Participants

Adverse Events

Belumosudil 200 mg QD

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Belumosudil 200 mg BID

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Belumosudil 400 mg QD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Belumosudil 200 mg QD n=13 participants at risk Participants received belumosudil 200 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 200 mg BID n=9 participants at risk Participants received belumosudil 200 mg tablet orally BID until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.	Belumosudil 400 mg QD n=1 participants at risk Participants received belumosudil 400 mg tablet orally QD until cGVHD progression, unacceptable toxicity or up to 2 years at the discretion of the Investigator.
Infections and infestations Covid-19	0.00% 0/13 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	11.1% 1/9 • Number of events 1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.
Infections and infestations Rhinovirus Infection	0.00% 0/13 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	11.1% 1/9 • Number of events 1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.
Metabolism and nutrition disorders Hyponatraemia	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/9 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.
Eye disorders Dacryoadenitis Acquired	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/9 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.
Vascular disorders Superior Vena Cava Syndrome	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/9 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.
Gastrointestinal disorders Tongue Dysplasia	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/9 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.	0.00% 0/1 • From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months Analysis was performed on the full analysis set.

Other adverse events

Additional Information

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