Chronic Graft Versus Host DiseasePhase 4NCT07135973
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
A Phase 4 study testing Belumosudil in people with Chronic Graft Versus Host Disease, run by Sanofi.
Trial summary
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: The study duration will be up to 12 months per participant. The treatment duration will be up to 24 weeks. Read more about this study
- Who is it for?
- Ages 12 years and older
- 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
- 26 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 17 Mar 2028
- Phase
- Phase 4
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent
- Participants who had an allogeneic hematopoietic cell transplantation (HCT)
- Previously received at least 2 prior lines of systemic therapy for cGVHD
- Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
- Had persistent cGVHD manifestations and systemic therapy was indicated
- Karnofsky (if aged ≥ 16 years)/Lansky (if aged <16 years) Performance Score of ≥ 60
- Capable of giving signed informed consent as described in the protocol
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Absolute neutrophil count ≤1.5 X 109/L
- Platelet count ≤ 50 X 109/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (>5 × ULN if due to cGVHD)
- Total bilirubin ≥ 1.5 X ULN
- Glomerular filtration rate (GFR) ≤ 30 mL/min/1.73m3
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- Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening
- FEV1 ≤39% or has lung score of 3
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
About this study
Official title: A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Belumosudil in Indian Participants, 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
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:
- The study duration will be up to 12 months per participant.
- The treatment duration will be up to 24 weeks.
- The number of visits will be 7.
- 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, Rezurock
Pharmaceutical form:Tablet-Route of administration:Oral
| Study group | Role | What they receive |
|---|---|---|
| belumosudil | Experimental | 200 mg taken orally once daily with food for 24 weeks Receives: Drug: Belumosudil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)
Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) during the treatment period (24 weeks)
Measured: From baseline to 24 weeks
Secondary outcomes (12)
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.
Measured: Baseline to end of study i.e. 12 months
Duration of Response (DOR)
Duration of Response (DOR) calculated from time of initial PR or CR until documented progression, death, or new systemic therapy.
Measured: Baseline to end of study i.e. 12 months
Time to Response (TTR)
Measured: Baseline to end of study i.e. 12 months
Response by organ system (including GSR)
Measured: Baseline to end of study i.e. 12 months
Time taken for New Treatment (TTNT) or death
Measured: Baseline to end of study i.e. 12 months
Failure-free survival (FFS)
Measured: Baseline to end of study i.e. 12 months
Overall survival (OS)
Measured: Baseline to end of study i.e. 12 months
Change in Corticosteroid dose.
Measured: Baseline to end of study i.e. 12 months
Change in CNI dose
Measured: Baseline to end of study i.e. 12 months
Symptomatic improvement from baseline during treatment based on 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
Measured: Baseline to end of study i.e. 12 months
Pulmonary Function Test (PFT)
Total lung capacity, Residual volume, Forced expiratory volume, Tidal volume
Measured: 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)
Measured: Baseline to end of study i.e. 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start30 Oct 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135973
- Sponsor's protocol ID
- LPS18471
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2025
- Last updated
- 23 Oct 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