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

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.

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.