A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chroni… (NCT07135973) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
26 participantsStarted 2026-08-10
Plain-language 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.
* The number of visits will be 7.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)
Timeframe: From baseline to 24 weeks
Trial details
NCT IDNCT07135973
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-08-30
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)