A Phase 4 interventional study of Belumosudil in Chronic Graft Versus Host Disease, sponsored by Sanofi. Completed at 2 sites in China. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
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.
376 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 104 are open to participants now.
This study's enrollment of 6 is below the median of 35 across 296 interventional studies indexed under Bronchiolitis Obliterans Syndrome.
Browse Bronchiolitis Obliterans Syndrome studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Participants will receive belumosudil 200 mg tablets orally QD in 28-day cycles until clinically significant progression of cGVHD
Drug: Belumosudil
Pharmaceutical form: Tablet Route of administration: Oral
Also known as: SAR445761/ KD025, Rezurock
Plasma concentrations of belumosudil at specified time points
Time frame: At Day 1 and Day 29(±3)
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.
Time frame: Up to 18 month
Duration of response (DoR)
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.
Time frame: 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
Time frame: Up to 18 month
Number and proportion of participants with dose reduction in corticosteroid during the treatment period
Time frame: 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
Time frame: 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
Time frame: Up to 18 month
Change in cGVHD severity based on physician-reported overall cGVHD activity
Time frame: Up to 18 month
Change in symptom activity assessed based on patient-reported cGVHD activity
Time frame: 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.
Time frame: Up to 18 month
Number and proportion of participants with calcineurin inhibitor (CNI) dose reduction or discontinuation during the treatment period
Time frame: Up to 18 month
Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and adverse events of special interest (AESIs)
Time frame: Up to 18 month
Plan to share: Yes — 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
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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