Trial · NCT02841995
A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
NCT02841995, Phase 2, Completed, Kadmon, a Sanofi Company; results first posted 2023-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease. Trials, record NCT02841995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02841995
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
- NCT number
- NCT02841995
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Kadmon, a Sanofi Company
- Conditions
- Graft vs Host Disease
- Interventions
- Belumosudil (KD025)
- First posted
- 2016-07-22
- Last updated
- 2023-06-28
- Results first posted
- 2023-06-28
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Response (OR) | 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 64.2 months) | OR was defined as the percentage of participants with complete response (CR) or partial response (PR). The OR determination of chronic graft versus host disease (cGVHD) was based on cGVHD response assessment performed by clinicians as per the 2014 National Institutes of Health (NIH) Consensus Development Project for Clinical Trials in cGVHD criteria. CR was defined as the resolution of all manifestations 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; and cGVHD progression was defined as the clinically meaningful worsening in 1 or more organs regardless of improvement in other organs. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months) | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) 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 were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study drug up to 28 days after the last dose of study drug). TEAEs included both SAEs and non-SAEs. |
| Secondary | Number of Participants With Best Overall Response (BOR) | 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 64.2 months) | BOR was defined as the participants with either a CR or PR or lack of response (LOR), where LOR included the response status of unchanged (LOR-U), mixed (LOR-M), or progression (LOR-P). BOR was assessed per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria. CR was defined as the resolution of all manifestations 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; LOR-M was defined as CR or PR in at least one organ accompanied by progression in another organ, LOR-U was defined as outcomes that did not meet the criteria for CR, PR, progression or mixed response, LOR-P was defined as progression in at least one organ or site without a response in any other organ or site. |
| Secondary | Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment | From Baseline up to end of treatment (i.e., up to 64.2 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 gastrointestinal (GI) track, lower GI tract, liver, lungs, and joints and fascia plus GSR. End of treatment (EOT) visit was performed within 3 days after participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. 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. Only those categories in which at least 1 participant had data were reported. |
| Secondary | Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report | From Baseline up to end of treatment (i.e., up to 64.2 months) | cGVHD symptom severity was self-reported by participants. Participants were asked to rate their disease symptom severity over the last week on the following questions: skin itching at its worst, moth dryness at its worst, mouth pain at its worst, mouth sensitivity at its worst, main compliant on eyes, symptom severity on eyes. Severity rating was done on a 0 to 10-point numeric rating scare, where score 0 indicated 'not at all severe cGVHD symptoms' and score 10 indicated 'most severe cGVHD symptoms possible'. EOT visit was performed within 3 days after participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. Maximal improvement from Baseline was calculated as the lowest symptom severity score on scheduled visits minus the symptom severity score at Baseline with possible ranges from -10 to 10. The lower the number means the better improvement in cGVHD symptoms. |
| Secondary | Failure-free Survival (FFS) | From first dose of study drug to either start of another new systemic treatment for cGVHD, relapse of the underlying disease or death or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Failure-free survival was defined as the time (in months) from first dose of study drug to either the start of another new systemic treatment for cGVHD, relapse of the underlying disease or death. If no such events happened, FFS was censored by last response assessment or long term follow up assessment, whichever was the latest and available. Kaplan-Meier survival method was used for the analysis. |
| Secondary | Change From Baseline in Corticosteroids Dose | Baseline up to end of treatment (i.e., anytime up to 64.2 months) | Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. EOT visit was performed within 3 days after the participant's last dose of study drug. |
| Secondary | Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage | Baseline up to end of treatment (i.e., anytime up to 64.2 months) | Calcineurin inhibitors included systemic tacrolimus and cyclosporine. Number of participants who took CNI at Baseline and had reduction and discontinuation in CNI use as compared to Baseline during the study are reported in this outcome measure. EOT visit was performed within 3 days after the participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. |
| Secondary | Duration of Response (DOR) | From the date of first response until documented disease progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | The DOR was defined as the time (in weeks) from first documentation of response to the time of first documentation of deterioration from best response (e.g., CR to PR, or PR to LR). LOR included the response status of unchanged (LOR-U), mixed (LOR-M), or progression (LOR-P). Per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria; CR was defined as the resolution of all manifestations 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; LOR-M was defined as CR or PR in at least one organ accompanied by progression in another organ, LOR-U was defined as outcomes that did not meet the criteria for CR, PR, progression or mixed response, LOR-P was defined as progression in at least one organ or site without a response in any other organ or site. Kaplan-Meier was used for the analysis. |
| Secondary | Time-to-Response (TTR) | From first dose of study drug treatment to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Time-to-response was measured as the time (in weeks) from first dose of study drug to the time of first documentation of response. Response was defined as the participants achieving a PR or CR at any post-baseline response assessment. Per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria; CR was defined as the resolution of all manifestations in each organ or site and PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Overall Response (OR) | 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 64.2 months) | Analysis was performed on mITT population. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months) | Analysis was performed on safety population which included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Best Overall Response (BOR) | 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 64.2 months) | Analysis was performed on mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment | From Baseline up to end of treatment (i.e., up to 64.2 months) | Analysis was performed on mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report | From Baseline up to end of treatment (i.e., up to 64.2 months) | Analysis was performed on mITT population. Only those categories in which at least 1 participant had data were reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Failure-free Survival (FFS) | From first dose of study drug to either start of another new systemic treatment for cGVHD, relapse of the underlying disease or death or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on mITT population. | months | MEDIAN |
| SECONDARY | Change From Baseline in Corticosteroids Dose | Baseline up to end of treatment (i.e., anytime up to 64.2 months) | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | milligrams per kilogram per day | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage | Baseline up to end of treatment (i.e., anytime up to 64.2 months) | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants who had taken CNI at Baseline and with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | From the date of first response until documented disease progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on responder population which included participants who received at least 1 dose of study medication and achieved a PR or CR response at any post-baseline response assessment. | weeks | MEDIAN |
| SECONDARY | Time-to-Response (TTR) | From first dose of study drug treatment to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on responder population. | weeks | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group881
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Response (OR) | Cohort 1: Belumosudil 200 mg QD | 64.7 | 95% Confidence Interval 38.3 to 85.8 | percentage of participants | |
| Percentage of Participants With Overall Response (OR) | Cohort 2: Belumosudil 200 mg BID | 68.8 | 95% Confidence Interval 41.3 to 89.0 | percentage of participants | |
| Percentage of Participants With Overall Response (OR) | Cohort 3: Belumosudil 400 mg QD | 57.1 | 95% Confidence Interval 34.0 to 78.2 | percentage of participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | Cohort 1: Belumosudil 200 mg QD | TEAE | 17 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | Cohort 2: Belumosudil 200 mg BID | TEAE | 16 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | Cohort 3: Belumosudil 400 mg QD | TEAE | 20 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | Cohort 1: Belumosudil 200 mg QD | TESAE | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | Cohort 2: Belumosudil 200 mg BID | TESAE | 6 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | Cohort 3: Belumosudil 400 mg QD | TESAE | 13 | Participants | |
| Number of Participants With Best Overall Response (BOR) | Cohort 1: Belumosudil 200 mg QD | CR | 0 | Participants |
1 to 10 of 881Source ClinicalTrials.gov
See all 881 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Belumosudil 200 mg QD | 17 | |
| Overall Study | STARTED | Cohort 2: Belumosudil 200 mg BID | 16 | |
| Overall Study | STARTED | Cohort 3: Belumosudil 400 mg QD | 21 | |
| Overall Study | COMPLETED | Cohort 1: Belumosudil 200 mg QD | 0 | |
| Overall Study | COMPLETED | Cohort 2: Belumosudil 200 mg BID | 0 | |
| Overall Study | COMPLETED | Cohort 3: Belumosudil 400 mg QD | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1: Belumosudil 200 mg QD | 17 | |
| Overall Study | NOT COMPLETED | Cohort 2: Belumosudil 200 mg BID | 16 | |
| Overall Study | NOT COMPLETED | Cohort 3: Belumosudil 400 mg QD | 21 |
Source ClinicalTrials.gov
Adverse events726
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 | Anaemia | Blood and lymphatic system disorders | Cohort 1 200 mg QD | 5 | 17 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 200 mg BID | 4 | 16 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 400 mg QD | 0 | 21 | 0 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Cohort 1 200 mg QD | 1 | 17 | 1 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Cohort 2 200 mg BID | 0 | 16 | 0 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Cohort 3 400 mg QD | 0 | 21 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 1 200 mg QD | 1 | 17 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 2 200 mg BID | 0 | 16 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 3 400 mg QD | 1 | 21 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1 200 mg QD | 0 | 17 | 0 |
1 to 10 of 726Source ClinicalTrials.gov
See all 726 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 200 mg QD | 5 | 17 |
| Total, all-cause mortality | Cohort 2 200 mg BID | 5 | 16 |
| Total, all-cause mortality | Cohort 3 400 mg QD | 9 | 21 |
| Total, other adverse events | Cohort 1 200 mg QD | 17 | 17 |
| Total, other adverse events | Cohort 2 200 mg BID | 16 | 16 |
| Total, other adverse events | Cohort 3 400 mg QD | 19 | 21 |
| Total, serious adverse events | Cohort 1 200 mg QD | 5 | 17 |
| Total, serious adverse events | Cohort 2 200 mg BID | 6 | 16 |
| Total, serious adverse events | Cohort 3 400 mg QD | 13 | 21 |
Source ClinicalTrials.gov
Papers2
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/NCT02841995
GET https://conductscience.org/api/trials/v1/NCT02841995/registered?page=2