A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 4

Age range

12 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

26 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• 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

Exclusion Criteria:

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
• 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

Sanofi

Study start

Nov 20, 2026 Estimated

Primary completion

Aug 30, 2027 Estimated

Study completion

Mar 17, 2028 Estimated

First posted

Aug 22, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts