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This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.
Study details include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| belumosudil | Experimental | 200 mg taken orally once daily with food for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belumosudil | Drug | Pharmaceutical form:Tablet-Route of administration:Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) | Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) during the treatment period (24 weeks) | From baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall Response (BoR) | Best overall Response (BoR), defined as the proportion of patients who achieved complete response (CR) or partial response (PR) according to the NIH Consensus Criteria. | Baseline to end of study i.e. 12 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | contact-us@sanofi.com |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| ID | Term |
|---|---|
| C000718240 | belumosudil |
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Duration of Response (DOR) calculated from time of initial PR or CR until documented progression, death, or new systemic therapy. |
| Baseline to end of study i.e. 12 months |
| Time to Response (TTR) | Baseline to end of study i.e. 12 months |
| Response by organ system (including GSR) | Baseline to end of study i.e. 12 months |
| Time taken for New Treatment (TTNT) or death | Baseline to end of study i.e. 12 months |
| Failure-free survival (FFS) | Baseline to end of study i.e. 12 months |
| Overall survival (OS) | Baseline to end of study i.e. 12 months |
| Change in Corticosteroid dose. | Baseline to end of study i.e. 12 months |
| Change in CNI dose | Baseline to end of study i.e. 12 months |
| Symptomatic improvement from baseline during treatment based on modified Lee Symptom Scale | defined as a ≥7-point reduction from baseline in total symptom score on a scale of 0 to 100 which measures the symptoms of chronic GVHD, with higher scores indicating worse symptoms | Baseline to end of study i.e. 12 months |
| Pulmonary Function Test (PFT) | Total lung capacity, Residual volume, Forced expiratory volume, Tidal volume | Baseline to end of study i.e. 12 months |
| Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs) | Baseline to end of study i.e. 12 months |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |