Trial · NCT05305989
Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213
NCT05305989, Phase 2, Completed, Kadmon, a Sanofi Company; results first posted 2025-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213. Trials, record NCT05305989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05305989
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213
- NCT number
- NCT05305989
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Kadmon, a Sanofi Company
- Conditions
- Chronic Graft-versus-host-disease
- Interventions
- Belumosudil 200 mg QD, Belumosudil 200 mg BID, Belumosudil 400 mg QD
- First posted
- 2022-03-31
- Last updated
- 2025-05-02
- Results first posted
- 2025-05-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Response (DOR) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | 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. |
| Primary | 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) | Baseline (Day 1) up to 23 months | 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. |
| Primary | Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale | Baseline (Day 1) up to 23 months | 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. |
| Primary | Time to Next Treatment (TTNT) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | 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. |
| Primary | Failure-Free Survival (FFS) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | 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. |
| Primary | Overall Survival (OS) | From first dose of study drug (Day 1) to the date of death due to any cause, up to approximately 24 months | 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. |
| Primary | Percentage of Participants With Complete Response (CR) and Partial Response (PR) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | 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. |
| Primary | Number of Participants With Best Response by Organ System | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | 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. |
| Primary | Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | Baseline (Day 1) and Month 23 | 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 \[NCT03640481\]). |
| Primary | Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment | From Baseline (Day 1) up to 23 months | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Response (DOR) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | 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. | months | MEDIAN |
| PRIMARY | 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) | Baseline (Day 1) up to 23 months | The full analysis set included all participants enrolled in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale | Baseline (Day 1) up to 23 months | The full analysis set included all participants enrolled in the study. Only those participants with \>=7PtR from Baseline are included in the analysis. | weeks | MEAN |
| PRIMARY | Time to Next Treatment (TTNT) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | The full analysis set included all participants enrolled in the study. | months | MEDIAN |
| PRIMARY | Failure-Free Survival (FFS) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | The full analysis set included all participants enrolled in the study. | months | MEDIAN |
| PRIMARY | Overall Survival (OS) | From first dose of study drug (Day 1) to the date of death due to any cause, up to approximately 24 months | The full analysis set included all participants enrolled in the study. | months | MEDIAN |
| PRIMARY | Percentage of Participants With Complete Response (CR) and Partial Response (PR) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | The full analysis set included all participants enrolled in the study. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Best Response by Organ System | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | The full analysis set included all participants enrolled in the study. Only those participants with data collected for each specified category are reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | Baseline (Day 1) and Month 23 | The full analysis set included all participants enrolled in the study. Only those participants with data collected at specified timepoints are reported. | percent change | MEDIAN |
| PRIMARY | Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment | From Baseline (Day 1) up to 23 months | The full analysis set included all participants enrolled in the study. Only those categories in which at least 1 participant had data are reported. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group93
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Response (DOR) | Belumosudil 200 mg QD | NA | 95% Confidence Interval 5.55 to NA | months | |
| Duration of Response (DOR) | Belumosudil 200 mg BID | NA | 95% Confidence Interval 5.78 to NA | months | |
| 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) | Belumosudil 200 mg QD | >=7PtR From Baseline | 8 | 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) | Belumosudil 200 mg BID | >=7PtR From Baseline | 2 | 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) | Belumosudil 400 mg QD | >=7PtR From Baseline | 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) | Belumosudil 200 mg QD | >=7PtR From Baseline on 2 Consecutive Post-Baseline Assessment | 8 | 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) | Belumosudil 200 mg BID | >=7PtR From Baseline on 2 Consecutive Post-Baseline Assessment | 1 | 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) | Belumosudil 400 mg QD | >=7PtR From Baseline on 2 Consecutive Post-Baseline Assessment | 0 | Participants | |
| Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale | Belumosudil 200 mg QD | 67.2 | Standard Deviation 26.8 | weeks | |
| Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale | Belumosudil 200 mg BID | 49.5 | Standard Deviation 54.2 | weeks |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belumosudil 200 mg QD | 13 | |
| Overall Study | STARTED | Belumosudil 200 mg BID | 9 | |
| Overall Study | STARTED | Belumosudil 400 mg QD | 1 | |
| Overall Study | COMPLETED | Belumosudil 200 mg QD | 0 | |
| Overall Study | COMPLETED | Belumosudil 200 mg BID | 0 | |
| Overall Study | COMPLETED | Belumosudil 400 mg QD | 0 | |
| Overall Study | NOT COMPLETED | Belumosudil 200 mg QD | 13 | |
| Overall Study | NOT COMPLETED | Belumosudil 200 mg BID | 9 | |
| Overall Study | NOT COMPLETED | Belumosudil 400 mg QD | 1 |
Source ClinicalTrials.gov
Adverse events228
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Covid-19 | Infections and infestations | Belumosudil 200 mg QD | 1 | 13 | 1 |
| other | Covid-19 | Infections and infestations | Belumosudil 200 mg BID | 0 | 9 | 0 |
| other | Covid-19 | Infections and infestations | Belumosudil 400 mg QD | 0 | 1 | 0 |
| other | Conjunctivitis | Infections and infestations | Belumosudil 200 mg QD | 0 | 13 | 0 |
| other | Conjunctivitis | Infections and infestations | Belumosudil 200 mg BID | 2 | 9 | 2 |
| other | Conjunctivitis | Infections and infestations | Belumosudil 400 mg QD | 0 | 1 | 0 |
| other | Ear Infection | Infections and infestations | Belumosudil 200 mg QD | 1 | 13 | 1 |
| other | Ear Infection | Infections and infestations | Belumosudil 200 mg BID | 0 | 9 | 0 |
| other | Ear Infection | Infections and infestations | Belumosudil 400 mg QD | 0 | 1 | 0 |
| other | Fungal Infection | Infections and infestations | Belumosudil 200 mg QD | 1 | 13 | 1 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belumosudil 200 mg QD | 0 | 13 |
| Total, all-cause mortality | Belumosudil 200 mg BID | 0 | 9 |
| Total, all-cause mortality | Belumosudil 400 mg QD | 0 | 1 |
| Total, other adverse events | Belumosudil 200 mg QD | 8 | 13 |
| Total, other adverse events | Belumosudil 200 mg BID | 7 | 9 |
| Total, other adverse events | Belumosudil 400 mg QD | 0 | 1 |
| Total, serious adverse events | Belumosudil 200 mg QD | 4 | 13 |
| Total, serious adverse events | Belumosudil 200 mg BID | 2 | 9 |
| Total, serious adverse events | Belumosudil 400 mg QD | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05305989/results?page=2