A Phase 2 interventional study of Belumosudil in Chronic Graft Versus Host Disease, sponsored by Kadmon, a Sanofi Company. Withdrawn. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Kadmon, a Sanofi Company (part of Sanofi) · Phase 2, Interventional, and Treatment
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Among 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome — 7 open to participants now, 8 under way, 2 of them phase 3. belumosudil · Bronchiolitis Obliterans Syndrome.
Among the 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome, this one is the 14th largest by enrollment, is one of 2 that started in 2025, is one of 8 in phase 2, and was the 4th registered.
714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.
Browse Bronchiolitis Obliterans Syndrome studies →7 of the 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome are open now, in 12 countries. Recruiting first, the newest first:
Sanofi · Sites in Netherlands, Spain
Ages 12+
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
Sanofi · Sites in United States, Belgium, Canada and 10 more countries
Ages 1–18
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
belumosudil: first FDA approval 2021 (REZUROCK), first EMA approval 2026. What it is approved for, and how studies give it, is on its page →
Of the 100 Bronchiolitis Obliterans Syndrome studies recruiting now, 45 (45%) set no upper age limit and 45 (45%) stop at 75 or younger; 25 take children under 18; 12 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 34 across the 14 interventional studies. Of the 4 that completed or were terminated, 3 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 14 have an industry lead sponsor. The 7 most frequent:
This study is registered under Kadmon, a Sanofi Company, one of the names counted as Sanofi. Under that name alone:
Kadmon, a Sanofi Company is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
11 studies in Bronchiolitis Obliterans Syndrome by Sanofi: 4 open now, 5 under way, 2 of them phase 3. Of 5 finished, 3 (60%) have results posted.
Among the 11 studies in Bronchiolitis Obliterans Syndrome by Sanofi, this one is the 11th largest by enrollment, is one of 2 that started in 2025, is one of 5 in phase 2, and was the 5th registered.
Sanofi’s Bronchiolitis Obliterans Syndrome studies by the year they started, since 2006.
3 of the studies testing belumosudil in Bronchiolitis Obliterans Syndrome that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07726914SanofiStudy to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants | 2027-01-26 |
| NCT05922761Dana-Farber Cancer InstituteBElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) | 2027-06-30 |
| NCT07135973SanofiA Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD) | 2027-08-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome, from their registry updates:
Among Sanofi’s 11 in Bronchiolitis Obliterans Syndrome:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above.
The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days.
Up to 4 weeks for screening, treatment until clinically significant progression of disease, 4 weeks of safety follow-up and then long-term follow-up every 12 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive belumosudil orally, once daily (QD) or twice daily (BID) if they are taking strong CYP3A4 inducers or proton pump inhibitors.
Drug: Belumosudil
Pharmaceutical form: Tablet; Route of administration: Oral
Also known as: KD025, SAR445761, Rezurock
Number of participants with treatment emergent adverse events and serious adverse events
Safety will be assessed by monitoring adverse events, physical Examinations, clinical laboratory evaluations, vital sign measurements, and ECG parameters.
Time frame: Up to approximately 48 months
Number of participants with clinically significant laboratory abnormalities
Time frame: Up to approximately 12 months
Change from baseline in systolic and diastolic blood pressure
Time frame: Baseline; up to approximately 12 months
Change from baseline in heart rate
Time frame: Baseline; up to approximately 12 months
Change from baseline in corrected QT interval using Fridericia's formula (QTc[F])
Time frame: Baseline; up to approximately 12 months
Overall Response Rate (ORR)
The ORR is defined as the proportion of participants meeting the overall response criteria assessment of Complete Response (CR) or Partial Response (PR) as defined by the 2014 NIH Consensus Development Project on Clinical Trials in cGVHD at any post-baseline response assessment.
Time frame: Up to approximately 12 months
Duration of Response (DOR)
Assessments of DOR includes * The time from first response to progression, death, or new systemic therapy for cGVHD * Time from initial response to start of additional systemic cGVHD therapy or death
Time frame: Up to approximately 12 months
Change from baseline in the Lee Symptom Scale Score: Number of participants with a ≥ 7-point reduction
Changes in symptom burden/bother will be assessed using the Lee Symptom Scale, a symptom scale designed for individuals with chronic Graft Versus Host Disease (cGVHD). The questionnaire asks participants to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by cGVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician's assessment.
Time frame: Baseline; up to approximately 12 months
Change from baseline in the Lee Symptom Scale Score: Number of participants with a ≥ 7-point reduction on 2 consecutive assessments
Changes in symptom burden/bother will be assessed using the Lee Symptom Scale, a symptom scale designed for individuals with chronic Graft Versus Host Disease (cGVHD). The questionnaire asks participants to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by cGVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician's assessment.
Time frame: Baseline; up to approximately 12 months
Change from baseline in the Lee Symptom Scale Score: Duration of a ≥ 7 point reduction
Changes in symptom burden/bother will be assessed using the Lee Symptom Scale, a symptom scale designed for individuals with chronic Graft Versus Host Disease (cGVHD). The questionnaire asks participants to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by cGVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician's assessment.
Time frame: Baseline; up to approximately 12 months
Response rate by organ system
The response rate for the nine individual organs (skin, eyes, mouth, esophagus, upper GI, lower GI, liver, lungs, and joints and fascia) will be assessed by the clinician.
Time frame: Up to approximately 12 months
Time to Response (TTR)
TTR defined as the time from the first dose of belumosudil to the first documented cGVHD response.
Time frame: Up to approximately 12 months
Time to Next Treatment (TTNT)
TTNT defined as the time from the first dose of belumosudil to the start of additional systemic cGVHD therapy.
Time frame: Up to approximately 12 months
Number of participants who have a best response of PR and CR
CR is defined as resolution of all manifestations of cGVHD in each organ or site. PR is defined as Improvement in at least 1 organ or site without progression in any other organ or site.
Time frame: Up to approximately 12 months
Change from baseline in corticosteroid dose
The prednisone equivalent dose of corticosteroids (mg/kg/day) during the study will be analyzed. The change in systemic corticosteroid dose over time will be determined.
Time frame: Baseline; up to approximately 12 months
Change from baseline in calcineurin inhibitor dose
The change in calcineurin inhibitor dose over time will be determined.
Time frame: Baseline; up to approximately 12 months
Failure-free survival (FFS)
FFS defined as the absence of new cGVHD systemic therapy, non-relapse mortality and recurrent malignancy. Median FFS (from first dose of belumosudil) will be analyzed.
Time frame: Up to approximately 12 months
Overall survival (OS)
OS defined as time from first dose of belumosudil to the date of death due to any cause.
Time frame: Up to approximately 12 months
Change from baseline in cGVHD global severity rating using the Clinician-Reported Global cGVHD Activity Assessment
Patient-reported outcome
Time frame: Baseline; up to approximately 12 months
Change from baseline in symptom activity as based on cGVHD Activity Assessment Patient Self-Report
Patient-reported outcome
Time frame: Baseline; up to approximately 12 months
Plasma belumosudil concentrations
Time frame: Day 1 of Cycles 2, 3, 5, and 7 (1 Cycle = 28 days)
No study locations are listed for this record.
Plan to share: 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
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Aug 2026, 14 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Belumosudil
Bronchiolitis Obliterans Syndrome →