Trial · NCT03919799
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
NCT03919799, Phase 2, Terminated, Kadmon, a Sanofi Company; results first posted 2023-08-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis. Trials, record NCT03919799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03919799
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
- NCT number
- NCT03919799
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Kadmon, a Sanofi Company
- Conditions
- System; Sclerosis, Diffuse Cutaneous Systemic Sclerosis
- Interventions
- Belumosudil (KD025), Placebo
- First posted
- 2019-04-18
- Last updated
- 2023-08-30
- Results first posted
- 2023-08-30
- Limitations and caveats
- The study was terminated early by the Sponsor due to slow enrollment and strategic consideration and was not driven due to any safety concerns.
Source ClinicalTrials.gov
Registered outcomes71
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | DB Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 24 | 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). |
| Secondary | OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52 | 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. |
| Secondary | DB Period: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | Baseline, 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. |
| Secondary | DB Period: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 | Baseline, 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. |
| Secondary | DB Period: Change From Baseline in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | Baseline, 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. |
| Secondary | DB Period: Change From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | Baseline, 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. |
| Secondary | DB Period: Change From Baseline in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24 | Baseline, 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. |
| Secondary | DB Period: Percentage Improvement in Modified Rodnan Skin Score at Week 24 | Baseline, 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. |
| Secondary | DB Period: Percentage Improvement in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 24 | Baseline, 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. |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 registered outcomesOutcomes71
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Week 24 | Analysis was performed on mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 24 | Week 24 | Analysis was performed on mITT population. LOCF method was used to handle missing data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52 | Week 52 | Analysis was performed on mITT population. | score on a scale | MEAN |
| SECONDARY | DB Period: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. 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. | percent predicted FVC | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Patient Global Assessment of Participant's Overall Health Using Visual Analogue Scale Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Change From Baseline in Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) Total Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Percentage Improvement in Modified Rodnan Skin Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. 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. | percentage improvement | LEAST_SQUARES_MEAN |
| SECONDARY | DB Period: Percentage Improvement in Physician Global Assessment of Participant's Overall Health Using Visual Analogue Scale (VAS) Score at Week 24 | Baseline, Week 24 | Analysis was performed on mITT population. 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. | percentage improvement | LEAST_SQUARES_MEAN |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 outcomesResults by group1,768
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | DB Period: Belumosudil QD | 6 | Participants | ||
| 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 | DB Period: Belumosudil BID | 3 | Participants | ||
| 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 | DB Period: Placebo | 7 | Participants | ||
| DB Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 24 | DB Period: Belumosudil QD | 14.30 | 95% Confidence Interval 9.47 to 19.12 | score on a scale | |
| DB Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 24 | DB Period: Belumosudil BID | 10.16 | 95% Confidence Interval 5.41 to 14.91 | score on a scale | |
| DB Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 24 | DB Period: Placebo | 14.34 | 95% Confidence Interval 10.04 to 18.64 | score on a scale | |
| OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52 | OLE Period: Belumosudil QD | 87.46 | Standard Deviation 27.376 | score on a scale | |
| OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52 | OLE Period: Placebo/Belumosudil QD | 7.16 | Standard Deviation 8.749 | score on a scale | |
| OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52 | OLE Period: Belumosudil BID | 64.37 | Standard Deviation 41.950 | score on a scale | |
| OLE Period: Combined Response Index in Diffuse Cutaneous Systemic Sclerosis Score at Week 52 | OLE Period: Placebo/Belumosudil BID | 11.62 | Standard Deviation 19.282 | score on a scale |
1 to 10 of 1,768Source ClinicalTrials.gov
See all 1,768 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DB Period (28 Weeks) | STARTED | Belumosudil QD/Belumosudil QD | 12 | |
| DB Period (28 Weeks) | STARTED | Belumosudil BID/Belumosudil BID | 12 | |
| DB Period (28 Weeks) | STARTED | DB Period: Placebo | 12 | |
| DB Period (28 Weeks) | STARTED | OLE Period: Placebo/Belumosudil QD | 0 | |
| DB Period (28 Weeks) | STARTED | OLE Period: Placebo/Belumosudil BID | 0 | |
| DB Period (28 Weeks) | Treated | Belumosudil QD/Belumosudil QD | 11 | |
| DB Period (28 Weeks) | Treated | Belumosudil BID/Belumosudil BID | 12 | |
| DB Period (28 Weeks) | Treated | DB Period: Placebo | 12 | |
| DB Period (28 Weeks) | Treated | OLE Period: Placebo/Belumosudil QD | 0 | |
| DB Period (28 Weeks) | Treated | OLE Period: Placebo/Belumosudil BID | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events1,043
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 | DB Period: Belumosudil QD | 0 | 11 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | DB Period: Belumosudil BID | 0 | 12 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | DB Period: Placebo | 1 | 12 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: Belumosudil QD | 0 | 10 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: Placebo/Belumosudil QD | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: Belumosudil BID | 0 | 10 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: Placebo/Belumosudil BID | 1 | 6 | 1 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | DB Period: Belumosudil QD | 0 | 11 | 0 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | DB Period: Belumosudil BID | 0 | 12 | 0 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | DB Period: Placebo | 0 | 12 | 0 |
1 to 10 of 1,043Source ClinicalTrials.gov
See all 1,043 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB Period: Belumosudil QD | 0 | 11 |
| Total, all-cause mortality | DB Period: Belumosudil BID | 0 | 12 |
| Total, all-cause mortality | DB Period: Placebo | 0 | 12 |
| Total, all-cause mortality | OLE Period: Belumosudil QD | 0 | 10 |
| Total, all-cause mortality | OLE Period: Placebo/Belumosudil QD | 0 | 5 |
| Total, all-cause mortality | OLE Period: Belumosudil BID | 0 | 10 |
| Total, all-cause mortality | OLE Period: Placebo/Belumosudil BID | 0 | 6 |
| Total, other adverse events | DB Period: Belumosudil QD | 10 | 11 |
| Total, other adverse events | DB Period: Belumosudil BID | 11 | 12 |
| Total, other adverse events | DB Period: Placebo | 11 | 12 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40088930 | DERIVED |
Source PubMed
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.
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