Chronic Graft Versus Host DiseasePhase 4NCT06616415
A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
A Phase 4 study testing Belumosudil in people with Chronic Graft Versus Host Disease, run by Sanofi at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- Belumosudil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesChina
- Study dates
- 4 Dec 2024to 12 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant must be 12 to less than 18 years of age at the time of signing the informed consent.
- Participant has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Has active moderate to severe cGVHD.
- Has received at least one line of prior systemic therapy for cGVHD.
- Participant must receive a corticosteroid therapy for cGVHD with a stable dose for at least 2 weeks prior to the first dose of the IMP.
- Has a Lansky-Play performance score of ≥60.
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- Participants should have an expected survival of longer than 6 months.
- Body weight of 30 kg and above.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Recurrence of hematologic neoplasms (according to the corresponding criteria for recurrence of primary hematologic neoplasms) or post-transplant lymphoproliferative disease at screening.
- Received investigational systemic therapy for cGVHD within 28 days prior to enrollment, unless the prior treatment had been washed out for at least 28 days or 5 half-lives prior to enrollment, whichever is shorter.
- Absolute neutrophil count (ANC) <1.0 × 10^9/L.
- Platelet count <50 × 10^9/L.
- Alanine aminotransferase (ALT) >3× the upper limit of normal (ULN), aspartate aminotransferase (AST) >3 × ULN.
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- Total bilirubin (TBIL) >1.5 × ULN (>3 ULN if Gilbert's syndrome).
- Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m^2 using the revised Bedside Schwartz formula . Revised Schwartz equation: CrCl (mL/min/1.73 m^2) = 0.413 × (height [in cm])/Creatinine (in mg/dL) at screening visit.
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Investigational Site Number : 1560001
Beijing, 100045
Investigational Site Number : 1560002
Shanghai, 200127
About this study
Official title: A Multicenter, Open-label, Single-arm, Phase 4 Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil Mesylate Tablets in Chinese Adolescents (Aged From 12 to Less Than 18 Years) With Chronic Graft-versus-host Disease (cGVHD) Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
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.
- Conditions
- Chronic Graft Versus Host Disease
- Being tested
- Belumosudil
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
Also called SAR445761/ KD025, Rezurock
Pharmaceutical form: Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Belumosudil | Experimental | Participants will receive belumosudil 200 mg tablets orally QD in 28-day cycles until clinically significant progression of cGVHD Receives: Drug: Belumosudil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of belumosudil at specified time points
Measured: At Day 1 and Day 29(±3)
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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
Measured: Up to 18 month
Number and proportion of participants with dose reduction in corticosteroid during the treatment period
Measured: 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
Measured: 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
Measured: Up to 18 month
Change in cGVHD severity based on physician-reported overall cGVHD activity
Measured: Up to 18 month
Change in symptom activity assessed based on patient-reported cGVHD activity
Measured: 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.
Measured: Up to 18 month
Number and proportion of participants with calcineurin inhibitor (CNI) dose reduction or discontinuation during the treatment period
Measured: Up to 18 month
Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and adverse events of special interest (AESIs)
Measured: Up to 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start4 Dec 2024
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616415
- Sponsor's protocol ID
- ACT18369
- Status last verified
- May 2026
- First submitted
- 24 Sep 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Phase 4 Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil Mesylate Tablets in Chinese Adolescents (Aged From 12 to Less Than 18 Years) With Chronic Graft-versus-host Disease (cGVHD) Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
- ClinicalTrials.gov ID
- NCT06616415
- Acronym / sponsor ID
- ACT18369
- Conditions
- Chronic Graft Versus Host Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belumosudil | Experimental | Drug: BelumosudilParticipants will receive belumosudil 200 mg tablets orally QD in 28-day cycles until clinically significant progression of cGVHD |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Participant must be 12 to less than 18 years of age at the time of signing the informed consent.
- Participant has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Has active moderate to severe cGVHD.
- Has received at least one line of prior systemic therapy for cGVHD.
- Participant must receive a corticosteroid therapy for cGVHD with a stable dose for at least 2 weeks prior to the first dose of the IMP.
Key exclusion criteria (9 listed)
- Recurrence of hematologic neoplasms (according to the corresponding criteria for recurrence of primary hematologic neoplasms) or post-transplant lymphoproliferative disease at screening.
- Received investigational systemic therapy for cGVHD within 28 days prior to enrollment, unless the prior treatment had been washed out for at least 28 days or 5 half-lives prior to enrollment, whichever is shorter.
- Absolute neutrophil count (ANC) <1.0 × 10^9/L.
- Platelet count <50 × 10^9/L.
- Alanine aminotransferase (ALT) >3× the upper limit of normal (ULN), aspartate aminotransferase (AST) >3 × ULN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelumosudilAlso: SAR445761/ KD025, RezurockPharmaceutical form: Tablet Route of administration: Oral | Drug | Belumosudil |
Primary outcome
Plasma concentrations of belumosudil at specified time points
Time frame: At Day 1 and Day 29(±3)
11 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 18 month
Duration of response (DoR)
Time frame: Up to 18 month
System organ response rate
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)
Time frame: Up to 18 month
Overall survival (OS)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- ACT18369 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belumosudil in people with Chronic Graft Versus Host Disease, run by Sanofi at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of belumosudil at specified time points (time frame: At Day 1 and Day 29(±3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.