Trial · NCT02688647
A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis
NCT02688647, Phase 2, Completed, Kadmon Corporation, LLC; results first posted 2022-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis. Trials, record NCT02688647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02688647
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis
- NCT number
- NCT02688647
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Kadmon Corporation, LLC
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Belumosudil, BSC
- First posted
- 2016-02-23
- Last updated
- 2022-09-08
- Results first posted
- 2022-09-08
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Mean Changes in FVC From Baseline to Week 24 | 24 weeks | Changes in the mean Forced Vital Capacity (FVC) from baseline at Week 24. Normal FVC-- Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy females 20 to 60 years: 3.25 to 3.75 L |
| Primary | Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24 | 24 weeks | Changes in the mean Forced Vital Capacity (FVC)% Predicted from baseline at Week 24. Normal FVC%: 80% to 120% |
| Primary | Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC had the option of crossing over at 24 weeks. | Percentage of subjects with non-serious TEAEs by relationship to treatment with belumosudil, BSC, or belumosudil and BSC. Severity of TEAEs were measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 22.1 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal). |
| Primary | Safety: Percentages of Subjects With SAEs Related to Study Treatment | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC and crossing over also up to 24 weeks of BSC. | Percentage of subjects with serious TEAEs by relationship to treatment with belumosudil and/or BSC. Investigators assessed whether events were related to treatment as possibly, probably, or definitely related. |
| Primary | Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil | Percentage of subjects with treatment-emergent adverse events (TEAEs) leading to subjects discontinuing from treatment. Investigators assessed whether TEAEs leading to discontinuation were related to study drug (possibly, probably, or definitely), belumosudil 400 mg PO QD. |
| Primary | Safety: Percentages of Subjects With Deaths Related to Study Treatment | Up to 96 weeks (Weeks 24, 8, and 96) of treatment with belumosudil. Subjects randomized to BSC also had the option of crossing over to treatment with belumosudil at 24 weeks. | Percentage of subjects with deaths by relationship to treatment with belumosudil, BSC, or belumosudil and BSC. Investigators assessed whether events were related to treatment as possibly, probably, or definitely related. |
| Secondary | Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- | 24 weeks | Changes in the mean Forced Vital Capacities (FVC) at Week 24 by Gender/Age/Physiology (GAP) Stage and by the previous use of pirfenidone and/or nintedanib prior to the study for Belumosudil-WC compared to BSC-NC. Normal FVC--Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy famles 20 to 60 years: 3.25 to 3.75 L GAP is measured by points as follows: (G) Gender: Female = 0 points; Male = 1 point (A) Age: ≤ 60 years = 0 points; 61-65 years = 1 point; \> 65 years = 2 points (P) Physiology: * FVC% Predicted: \> 75% = 0 points; 50-75% = 1 point; ≤ 50% = 2 points * DLCO% (diffusing lung capacity of carbon monoxide by % predicted) Predicted: \> 55% = 0 points; 36-55% = 1 point, ≤ 35% = 2 points; cannot perform = 3 points GAP Stage: * Stage I Index = 0 to 3 points * Stage II Index= 4 to 5 points * Stage III Index = 6 to 8 points |
| Secondary | Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT | Up to 96 weeks (Weeks 24, 48, and 96) | Changes in the mean Forced Vital Capacity (FVC) from baseline at Weeks 48 and 96, and End-of-Treatment (EOT) Normal FVC: Healthy males 20 to 60 years: 4.75 to 5.25 L; healthy females 20 to 60 years: 3.25 to 3.75 L |
| Secondary | Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT | Up to 96 weeks (Weeks 24, 48, and 96) | Change in the mean ratio of Forced Expiratory Volume in 1 Second (FEV1) divided by the Forced Vital Capacity (FVC) at Week 24, Week 48, Week 96, and End-of-Treatment (EOT) Normal FEV1: 80% to 120% FEV1/FVC = Within 5% of predicted ratio |
| Secondary | Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- | 24 weeks | Changes in the mean Forced Vital Capacities (FVC)% Predicted at Week 24 by Gender/Age/Physiology (GAP) Stage and by the previous use of pirfenidone and/or nintedanib prior to the study for Belumosudil-WC compared to BSC-NC. GAP is measured by points as follows: (G) Gender: Female = 0 points; Male = 1 point (A) Age: ≤ 60 years = 0 points; 61-65 years = 1 point; \> 65 years = 2 points (P) Physiology: * FVC% Predicted: \> 75% = 0 points; 50-75% = 1 point; ≤ 50% = 2 points * DLCO% (diffusing lung capacity of carbon monoxide by % predicted) Predicted: \> 55% = 0 points; 36-55% = 1 point, ≤ 35% = 2 points; cannot perform = 3 points GAP Stage: * Stage I = 0 to 3 points * Stage II = 4 to 5 points * Stage III = 6 to 8 points |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy: Mean Changes in FVC From Baseline to Week 24 | 24 weeks | Analysis was performed using randomized population. Available data for change from baseline at Week 24 have been reported. | mL | MEAN |
| PRIMARY | Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24 | 24 weeks | Analysis was performed using randomized population. Available data for change from baseline at Week 24 have been reported. | % of predicted | MEAN |
| PRIMARY | Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC had the option of crossing over at 24 weeks. | All subjects treated in study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Percentages of Subjects With SAEs Related to Study Treatment | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC and crossing over also up to 24 weeks of BSC. | All subjects treated in study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil | Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil | Subjects who received belumosudil 400 mg PO QD were included. Subjects who only received BSC and did not cross over to treatment with belumosudil were not included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Percentages of Subjects With Deaths Related to Study Treatment | Up to 96 weeks (Weeks 24, 8, and 96) of treatment with belumosudil. Subjects randomized to BSC also had the option of crossing over to treatment with belumosudil at 24 weeks. | All subjects treated in study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- | 24 weeks | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | mL | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT | Up to 96 weeks (Weeks 24, 48, and 96) | All randomized subjects | mL | MEAN |
| SECONDARY | Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT | Up to 96 weeks (Weeks 24, 48, and 96) | All randomized subjects | Units | MEAN |
| SECONDARY | Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- | 24 weeks | The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment. | % of predicted | GEOMETRIC_LEAST_SQUARES_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group375
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | Belumosudil-R | Baseline | 2608.2 | Standard Deviation 829.6 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | BSC-R | Baseline | 2516.7 | Standard Deviation 741.8 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | Belumosudil-WC | Baseline | 2608.8 | Standard Deviation 840.4 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | BSC-NC | Baseline | 2516.7 | Standard Deviation 741.8 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | Total | Baseline | 2569.3 | Standard Deviation 794.3 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | Belumosudil-R | At Week 24 | 2626.8 | Standard Deviation 886.9 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | BSC-R | At Week 24 | 2438.1 | Standard Deviation 757.1 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | Belumosudil-WC | At Week 24 | 2617.4 | Standard Deviation 890.8 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | BSC-NC | At Week 24 | 2436.8 | Standard Deviation 784.5 | mL |
| Efficacy: Mean Changes in FVC From Baseline to Week 24 | Total | At Week 24 | 2533.7 | Standard Deviation 832.7 | mL |
1 to 10 of 375Source ClinicalTrials.gov
See all 375 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment Period (24 Weeks) | STARTED | Belumosudil-R | 52 | |
| Initial Treatment Period (24 Weeks) | STARTED | BSC-R | 24 | |
| Initial Treatment Period (24 Weeks) | Treated | Belumosudil-R | 51 | |
| Initial Treatment Period (24 Weeks) | Treated | BSC-R | 24 | |
| Initial Treatment Period (24 Weeks) | COMPLETED | Belumosudil-R | 51 | |
| Initial Treatment Period (24 Weeks) | COMPLETED | BSC-R | 18 | |
| Initial Treatment Period (24 Weeks) | NOT COMPLETED | Belumosudil-R | 1 | |
| Initial Treatment Period (24 Weeks) | NOT COMPLETED | BSC-R | 6 | |
| Post Switch Treatment Period (72 Weeks) | STARTED | Belumosudil-R | 51 | |
| Post Switch Treatment Period (72 Weeks) | STARTED | BSC-R | 17 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,010
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 | Dyspnea | Respiratory, thoracic and mediastinal disorders | Belumosudil-R | 19 | 51 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | BSC-R | 5 | 24 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Belumosudil-WC | 21 | 68 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | BSC-NC | 4 | 24 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Total | 24 | 75 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Belumosudil-R | 14 | 51 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | BSC-R | 8 | 24 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Belumosudil-WC | 14 | 68 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | BSC-NC | 8 | 24 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Total | 22 | 75 |
1 to 10 of 1,010Source ClinicalTrials.gov
See all 1,010 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belumosudil-R | 7 | 51 |
| Total, all-cause mortality | BSC-R | 3 | 24 |
| Total, all-cause mortality | Belumosudil-WC | 9 | 68 |
| Total, all-cause mortality | BSC-NC | 1 | 24 |
| Total, all-cause mortality | Total | 10 | 75 |
| Total, other adverse events | Belumosudil-R | 50 | 51 |
| Total, other adverse events | BSC-R | 23 | 24 |
| Total, other adverse events | Belumosudil-WC | 67 | 68 |
| Total, other adverse events | BSC-NC | 19 | 24 |
| Total, other adverse events | Total | 73 | 75 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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.
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GET https://conductscience.org/api/trials/v1/NCT02688647
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