NCT07135973Not yet recruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 30 Oct 2026
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Sanofi
- NCT number
- NCT07135973
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 26
- From 30 Oct 2026 to the primary completion date, 30 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening
Lab values
- 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
Other
- Participants are excluded from the study if any of the following criteria apply:
- 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.
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.