Trial · NCT03640481
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
NCT03640481, Phase 2, Terminated, Kadmon, a Sanofi Company; results first posted 2024-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy. Trials, record NCT03640481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03640481
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
- NCT number
- NCT03640481
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 159 participants, actual
- Lead sponsor
- Kadmon, a Sanofi Company
- Conditions
- Chronic Graft-versus-host-disease
- Interventions
- Belumosudil (KD025)
- First posted
- 2018-08-21
- Last updated
- 2024-12-12
- Results first posted
- 2024-12-12
- Limitations and caveats
- The sponsor decided to prematurely terminate the study due to the challenges encountered in recruiting adolescent participants. This decision was made without any safety concerns.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | The ORR was defined as the percentage of participants with a best response meeting the overall response criteria assessment of complete response (CR) or partial response (PR) at any post-baseline response assessment. CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. Responses were assessed by the 2014 National Institutes of Health (NIH) Consensus Development Project on Clinical Trials in cGVHD. |
| Secondary | Duration of Response (DOR) | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | DOR is defined as the time from first documentation of response to the time of first documentation of deterioration from best response (e.g., CR to PR, or PR to Lack of response \[LR\]). CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. LR included the response status of mixed, unchanged, or progression. Mixed LR was defined as complete or partial response in at least one organ accompanied by progression in another organ. Unchanged LR was defined as outcomes that did not meet the criteria for complete response, partial response, progression or mixed response. Progression LR-P was defined as progression in at least one organ or site without a response in any other organ or site. Confidence interval (CI) is calculated using Kaplan-Meier method. |
| Secondary | Number of Participants With Improvement (>=7-Point Reduction [7-PtR] From Baseline) as Assessed by Lee Symptom Scale (LSS) Score | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | The questionnaire asked participants to indicate the degree of bother that they experienced due to symptoms in 7 domains potentially affected by chronic GVHD. 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 is scored 0, 1, 2, 3 or 4. 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 summary score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing. A higher score indicated more bothersome symptoms. A 7-point difference on the summary score of cGVHD symptom scale was found to be clinically meaningful. |
| Secondary | Number of Participants With Best Response by Organ System | From date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | The best response (CR, PR) for individual organs (skin, eyes, mouth, esophagus, upper gastrointestinal \[GI\], lower GI, liver, lungs, joints and fascia) were summarized. CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. |
| Secondary | Percentage of Participants With Best Response of PR and CR | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | PR was defined as the improvement in at least one organ or site without progression in any other organ or site. CR was defined as resolution of all manifestations of cGVHD in each organ or site. Responses were assessed by the 2014 NIH Consensus Development Project on Clinical Trials in cGVHD. |
| Secondary | Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms | 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. |
| Secondary | Percentage of Participants With Reduction and Discontinuation of Calcineurin Inhibitor Dose | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | Calcineurin inhibitors include systemic tacrolimus and cyclosporine. Percentage of participants with reduction and discontinuation of calcineurin inhibitor dose is presented. |
| Secondary | Failure-Free Survival (FFS) | From first dose of study drug to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | 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. |
| Secondary | Overall Survival (OS) | From first dose of study drug to date of death from any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | OS was defined as time from first dose of belumosudil to the date of death due to any cause. |
| Secondary | Number of Participants With Best Response of Global Severity Rating Score as Based on the Clinician-Reported Global cGVHD Activity Assessment | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | The Clinician-reported global cGVHD Activity Assessment is a 0-10 point numeric rating scale with a score of 0 indicating "cGVHD symptoms not at all severe" and a score of 10 being "most severe cGVHD symptoms possible". Higher scores indicated worse symptoms. Best response was defined as PR+CR. PR was defined as the improvement in at least one organ or site without progression in any other organ or site. CR was defined as resolution of all manifestations of cGVHD in each organ or site. Participants were categorized in 3 categories at baseline based on the global severity scores of \<6, =6-7 and \>7 and number of participants with best response for them is reported. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | Responder population included participants in the mITT population that achieved a partial or complete response at any post-baseline response assessment. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Improvement (>=7-Point Reduction [7-PtR] From Baseline) as Assessed by Lee Symptom Scale (LSS) Score | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Best Response by Organ System | From date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. Only those participants with data collected for each specified category are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Best Response of PR and CR | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | Baseline (Day 1) and 40.5 months for adult arms; Baseline (Day 1) and 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. Only those participants with data collected at specified timepoints are reported. | Percent change | MEDIAN |
| SECONDARY | Percentage of Participants With Reduction and Discontinuation of Calcineurin Inhibitor Dose | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. Only those participants who received CNI at baseline were included in the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Failure-Free Survival (FFS) | From first dose of study drug to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From first dose of study drug to date of death from any cause or data cut-off, whichever occurred first (maximum duration: up to 40.5 months for adult arms and 27.6 months for adolescent arms) | mITT population included all randomized participants who received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Number of Participants With Best Response of Global Severity Rating Score as Based on the Clinician-Reported Global cGVHD Activity Assessment | Baseline (Day 1) up to 40.5 months for adult arms; Baseline (Day 1) up to 27.6 months for adolescent arms | mITT population included all randomized participants who received at least one dose of study drug. Only participants with respective global severity rating score categories of \<6, =6-7 and \>7 assessed at baseline are reported. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Adult Arm A: Belumosudil 200 mg QD | 74.0 | Percentage of participants | ||
| Overall Response Rate (ORR) | Adult Arm B: Belumosudil 200 mg BID | 76.0 | Percentage of participants | ||
| Overall Response Rate (ORR) | Adolescent Arm A: Belumosudil 200 mg QD | 50.0 | Percentage of participants | ||
| Overall Response Rate (ORR) | Adolescent Arm B: Belumosudil 200 mg BID | 100.0 | Percentage of participants | ||
| Duration of Response (DOR) | Adult Arm A: Belumosudil 200 mg QD | 23.9 | 95% Confidence Interval 11.43 to 50.43 | Weeks | |
| Duration of Response (DOR) | Adult Arm B: Belumosudil 200 mg BID | 32.0 | 95% Confidence Interval 20.86 to 53.14 | Weeks | |
| Duration of Response (DOR) | Adolescent Arm A: Belumosudil 200 mg QD | 16.1 | 95% Confidence Interval NA to NA | Weeks | |
| Duration of Response (DOR) | Adolescent Arm B: Belumosudil 200 mg BID | 4.1 | 95% Confidence Interval NA to NA | Weeks | |
| Number of Participants With Improvement (>=7-Point Reduction [7-PtR] From Baseline) as Assessed by Lee Symptom Scale (LSS) Score | Adult Arm A: Belumosudil 200 mg QD | 45 | Participants | ||
| Number of Participants With Improvement (>=7-Point Reduction [7-PtR] From Baseline) as Assessed by Lee Symptom Scale (LSS) Score | Adult Arm B: Belumosudil 200 mg BID | 48 | Participants |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adult Arm A: Belumosudil 200 mg QD | 78 | |
| Overall Study | STARTED | Adult Arm B: Belumosudil 200 mg BID | 78 | |
| Overall Study | STARTED | Adolescent Arm A: Belumosudil 200 mg QD | 2 | |
| Overall Study | STARTED | Adolescent Arm B: Belumosudil 200 mg BID | 1 | |
| Overall Study | COMPLETED | Adult Arm A: Belumosudil 200 mg QD | 0 | |
| Overall Study | COMPLETED | Adult Arm B: Belumosudil 200 mg BID | 0 | |
| Overall Study | COMPLETED | Adolescent Arm A: Belumosudil 200 mg QD | 0 | |
| Overall Study | COMPLETED | Adolescent Arm B: Belumosudil 200 mg BID | 0 | |
| Overall Study | NOT COMPLETED | Adult Arm A: Belumosudil 200 mg QD | 78 | |
| Overall Study | NOT COMPLETED | Adult Arm B: Belumosudil 200 mg BID | 78 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events852
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 | Candida Infection | Infections and infestations | Adult Arm A: Belumosudil 200 mg QD | 5 | 77 | 7 |
| other | Candida Infection | Infections and infestations | Adult Arm B: Belumosudil 200 mg BID | 1 | 75 | 1 |
| other | Candida Infection | Infections and infestations | Adolescent Arm A: Belumosudil 200 mg QD | 0 | 2 | 0 |
| other | Candida Infection | Infections and infestations | Adolescent Arm B: Belumosudil 200 mg BID | 0 | 1 | 0 |
| other | Conjunctivitis | Infections and infestations | Adult Arm A: Belumosudil 200 mg QD | 6 | 77 | 7 |
| other | Conjunctivitis | Infections and infestations | Adult Arm B: Belumosudil 200 mg BID | 2 | 75 | 2 |
| other | Conjunctivitis | Infections and infestations | Adolescent Arm A: Belumosudil 200 mg QD | 0 | 2 | 0 |
| other | Conjunctivitis | Infections and infestations | Adolescent Arm B: Belumosudil 200 mg BID | 1 | 1 | 1 |
| other | Coronavirus Infection | Infections and infestations | Adult Arm A: Belumosudil 200 mg QD | 3 | 77 | 3 |
| other | Coronavirus Infection | Infections and infestations | Adult Arm B: Belumosudil 200 mg BID | 6 | 75 | 7 |
1 to 10 of 852Source ClinicalTrials.gov
See all 852 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adult Arm A: Belumosudil 200 mg QD | 14 | 77 |
| Total, all-cause mortality | Adult Arm B: Belumosudil 200 mg BID | 14 | 75 |
| Total, all-cause mortality | Adolescent Arm A: Belumosudil 200 mg QD | 0 | 2 |
| Total, all-cause mortality | Adolescent Arm B: Belumosudil 200 mg BID | 0 | 1 |
| Total, other adverse events | Adult Arm A: Belumosudil 200 mg QD | 73 | 77 |
| Total, other adverse events | Adult Arm B: Belumosudil 200 mg BID | 73 | 75 |
| Total, other adverse events | Adolescent Arm A: Belumosudil 200 mg QD | 2 | 2 |
| Total, other adverse events | Adolescent Arm B: Belumosudil 200 mg BID | 1 | 1 |
| Total, serious adverse events | Adult Arm A: Belumosudil 200 mg QD | 36 | 77 |
| Total, serious adverse events | Adult Arm B: Belumosudil 200 mg BID | 30 | 75 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03640481
GET https://conductscience.org/api/trials/v1/NCT03640481/results?page=2