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This is a single group, Phase 4, single-arm post-marketing study for treatment.
The purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants (aged from 12 to less than 18) with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies.
Participants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belumosudil | Experimental | Participants will receive belumosudil 200 mg tablets orally QD in 28-day cycles until clinically significant progression of cGVHD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belumosudil | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of belumosudil at specified time points | At Day 1 and Day 29(±3) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Overall response rate (ORR, including complete response [CR] and partial response [PR]), which will be assessed by the investigator according to the NIH Consensus Criteria (2014) at any time before the start of new systemic treatment for cGVHD. | Up to 18 month |
| 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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 1560001 | Beijing | 100045 | China | |||
| Investigational Site Number : 1560002 |
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| Label | URL |
|---|---|
| ACT18369 Plain Language Results Summary | View source |
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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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Duration of response (DoR): time from the date of the first response to the date of cGVHD progression as defined by 2014 NIH consensus response criteria, start of new systemic treatment for cGVHD, or death, whichever occurs first. DOR is determined only for participants who achieved overall response (PR or CR) as per 2014 NIH consensus response criteria. |
| Up to 18 month |
| System organ response rate | System organ response rate: proportion of participants who achieve an overall response (CR or PR) for each of the nine individual organs (Skin, Eyes, Mouth, Esophagus, Upper GI, Lower GI, Liver, Lungs, and Joints and fascia) as per 2014 NIH consensus response criteria at any time before the start of new systemic treatment for cGVHD | Up to 18 month |
| Number and proportion of participants with dose reduction in corticosteroid during the treatment period | Up to 18 month |
| Failure-free survival (FFS) | Failure-free survival (FFS): time from the date of the first administration of IMP to 1) the date of initiation of new systemic treatment for cGVHD, or 2) date of death, or 3) date of recurrent underlying disease, whichever occurs first | Up to 18 month |
| Overall survival (OS) | Overall survival (OS): time from the date of the first administration of IMP to the date of death due to any cause | Up to 18 month |
| Change in cGVHD severity based on physician-reported overall cGVHD activity | Up to 18 month |
| Change in symptom activity assessed based on patient-reported cGVHD activity | Up to 18 month |
| Modified Lee cGVHD Symptom Scale change | The scale contains 30 items grouped in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Patients report how "bothered" they feel about each symptom using a five-point Likert scale from "not at all" (0) to "extremely" (4). A higher score indicating worse symptoms, reporting score will be normalizing to a 0 to 100 scale. | Up to 18 month |
| Number and proportion of participants with calcineurin inhibitor (CNI) dose reduction or discontinuation during the treatment period | Up to 18 month |
| Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and adverse events of special interest (AESIs) | Up to 18 month |
| Shanghai |
| 200127 |
| China |
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000718240 | belumosudil |
| C000619755 | KD025 |
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