Chronic Graft Versus Host DiseasePhase 3NCT07771439
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
A Phase 3 study testing Belumosudil and Best available therapy (BAT) in people with Chronic Graft Versus Host Disease, run by Sanofi at 3 sites in 2 countries.
Trial summary
Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No)… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- Belumosudil and Best available therapy (BAT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Oct 2026to 2 Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant must be at least 12 years of age at the time of signing the informed consent.
- Participants who have undergone allo-HCT.
- Participants with active moderate to severe cGVHD at the time of enrollment, defined using the NIH Consensus diagnosis and staging criteria for which the physician believes a new line of systemic therapy is required.
- Participant receiving systemic CNI and/or CS must be on a stable dose/regimen (prednisone equivalent <1 mg/kg/day for CS) for at least 2 weeks prior to randomization.
- cGVHD is refractory to, or has recurred following, at least 2 prior lines of systemic treatment. Participants must have received a minimum of 2 and a maximum of 5 prior systemic therapies for cGVHD.
- Participant must have received ruxolitinib for the treatment of cGVHD unless the Investigator believes treatment with ruxolitinib for cGVHD was not suitable for the participant.
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- Participants and/or their LAR must accept to be treated with 1 of the following BAT options as recommended to them by the Investigator on Cycle 1 Day 1:
- ECP,
- Low-dose MTX,
- MMF,
- Rituximab,
- mTOR inhibitors (sirolimus, everolimus)
- Imatinib,
- Ibrutinib,
- Proteasome inhibitors,
- Pentostatin.
- Body weight ≥ 30 kg I 09. Life expectancy of > 6 months.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease or post-transplant lymphoproliferative disease after most recent allo-HCT.
- Participants who meet any of the following criteria regarding systemic cGVHD treatments:
- Participants who newly initiated any systemic cGVHD treatment within 14 days prior to the date of randomization.
- Participants receiving systemic ruxolitinib treatment who are unable to meet the following requirements:
- Ruxolitinib must be tapered and discontinued within 14 days following the first dose of belumosudil or BAT (allowing for a maximum overlap period of up to 14 days with belumosudil or BAT treatment).
- No dose increases of ruxolitinib are permitted from 14 days prior to the date of randomization until permanent discontinuation of ruxolitinib (dose reductions and discontinuations are permitted during this period).
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- Participants receiving other systemic cGVHD treatment (apart from CS and CNI) including investigational treatments who have not completed a washout period of at least 14 days or 5 half-lives (whichever is shorter) prior to the first dose of belumosudil or BAT treatment.
- Note: Topical and organ-specific treatment for cGVHD and other supportive agents are allowed.
- Participant has had previous exposure to belumosudil.
- Participants with a Karnofsky Performance Scale (KPS) score <60 (if aged ≥16 years) or Lansky Performance Score of <60 (if aged <16 years).
- Clinically uncontrolled chronic or ongoing infectious disease requiring antibiotic, antiviral, or antifungal treatment within 14 days prior to the date of randomization.
- Impairment of GI function (unrelated to cGVHD) or GI disease (unrelated to cGVHD) that may significantly alter the absorption of belumosudil (such as ulcerative disease, malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or small bowel resection).
- Administration of live or live-attenuated vaccines is prohibited within 28 days or 5 elimination half-lives of the respective vaccine, whichever is longer, prior to study treatment administration and until study intervention discontinuation.
- Has a forced expiratory volume in the first second (FEV1) ≤39% or has lung score of 3 according to 2014 NIH consensus diagnostic and staging criteria.
- Has any of the following lab results:
- Absolute neutrophil count <1.5 × 10⁹/L (for participants aged <18 years) or <1.0 × 109/L (for participants aged ≥18 years). The use of G-CSF is not allowed within 7 days before the screening hematological test.
- Platelet count <50 × 10⁹/L (for participants aged <18 years) or <25 × 109/L (for participants aged ≥18 years). Platelet transfusions are not allowed within 72 hours before the screening hematological test.
- ALT and/or AST >3 × ULN (>5 × ULN if abnormalities are due to cGVHD).
- Total bilirubin >1.5 × ULN (>3 × ULN if Gilbert's syndrome or due to cGVHD).
- eGFR <30 mL/min/1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged <18 years).
- Participants with active viral diseases
- Diagnosed or treated for another malignancy other than the underlying disease allo-HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy.
- Hepatic impairment classified as Child-Pugh C or worse, with the exception of transient liver impairment attributable to GVHD.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
3 sites in 2 countries
Spain2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7240008
Madrid, Madrid, Comunidad de, 28034
- Recruiting
Investigational Site Number : 7240009
Madrid, 28007
Netherlands1 site, 1 recruiting
- Recruiting
Investigational Site Number : 5280001
Amsterdam, 1081 HV
About this study
Official title: A Parallel Group, Phase 3, Randomized, Open-label, 2-arm Study to Demonstrate the Superiority of Belumosudil Versus Best Available Therapy (BAT) in Participants at Least 12 Years of Age With Chronic Graft Versus Host Disease (cGVHD) Refractory to or Recurrent After 2 to 5 Prior Lines of Systemic Therapy
Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation. The study will target patients post-ruxolitinib treatment, except where Investigators deemed ruxolitinib treatment for cGVHD not suitable. In the BAT arm, the study doctor will select one BAT based on clinical judgement, local availability etc. prior to randomization.
Participants randomized to the BAT arm will have the option to cross-over to open-label belumosudil treatment upon meeting predefined criteria.
Read more
Study details include:
- The study duration will be defined as 3 years from LPI.
- Individual participant duration on study will consist of:
- Up to 28 days for screening.
- Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD (except change from BAT to belumosudil during the cross-over), experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first.
- Thirty days of post treatment safety follow-up.
- Follow-up for cGVHD status as applicable.
- Long-term follow-up until death or end of study, whichever occurs first.
- Conditions
- Chronic Graft Versus Host Disease
- Being tested
- Belumosudil, Best available therapy (BAT)
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
Also called SAR445761
Pharmaceutical form:Tablet-Route of administration:oral
Best available therapy (BAT)Other
Participants will receive BAT based on the Investigator's judgment
| Study group | Role | What they receive |
|---|---|---|
| Belumosudil | Experimental | Participants will receive belumosudil Receives: Drug: Belumosudil |
| best available therapy(BAT) | Other | Participants will receive BAT based on the Investigator's judgment Receives: Other: Best available therapy (BAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate at 24 weeks defined as the proportion of participants who achieve an overall response (PR or CR) without the requirement of new systemic therapy as per NIH consensus response criteria (2014) at Week 24.
Measured: at week 24
Secondary outcomes (17)
Time from the date of randomization to the date of start of new systemic treatment for cGVHD, relapse or recurrence of underlying disease, or death, whichever occurs first.
Measured: Until the end of study, up to approximately 3 years from Last Participant In
Proportion of participants achieving at least 6-point reduction from baseline in the modified Lee cGVHD Symptom Scale score at Week 24.
Measured: at 24 week
Proportion of participants who achieve an overall response (CR or PR) within up to 24 weeks and without the requirement of new systemic therapy as per NIH consensus response criteria (2014).
Measured: up to 24 weeks
Proportion of participants who achieve an overall response (CR or PR) based on NIH consensus response criteria (2014) at any time until start of new systemic therapy for cGVHD.
Measured: Until the end of study, up to approximately 3 years from Last Participant In
The time from first response of PR or CR until documented progression, new systemic treatment for cGVHD, or death, whichever occurs first.
Measured: Until the end of study, up to approximately 3 years from Last Participant In
Time from randomization to the first response (either CR or PR) per NIH consensus response criteria (2014) for cGVHD.
Measured: Until the end of study, up to approximately 3 years from Last Participant In
Time from the date of randomization to the date of starting a new systemic therapy for cGVHD.
Measured: Until the end of study, up to approximately 3 years from Last Participant In
Proportion of participants who achieve CR or PR based on NIH consensus criteria (2014) at any time point in each involved organ and before the start of new systemic therapy for cGVHD.
Measured: Until the end of study, up to approximately 3 years from Last Participant In
The time from the date of randomization to the date of death from any cause.
Measured: Until the end of study, up to approximately 3 years from Last Participant In
Proportion of participants with >50% reduction from baseline in daily CS dose at Week 24.
Measured: at Week 24
Proportion of participants with discontinuation of CS at Week 24.
Measured: at Week 24
Proportion of participants with >50% reduction from baseline in daily CNI dose at Week 24.
Measured: at Week 24
Proportion of participants with discontinuation of CNI at Week 24.
Measured: at Week 24
Incidence of TEAEs, SAEs, and AESIs.
Measured: From first dose of study treatment until 30 days after last dose (up to 3.3 years)
The cumulative incidence of relapse or recurrence of the underlying disease at any time during the study.
Measured: Until the end of study, up to approximately 3 years from Last Participant In
Belumosudil plasma concentrations.
Measured: at Cycle 1 Day 15, Cycle 2 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. A cycle is defined as a 28-day period
Change from baseline in SF-36v2 domain scores and composite Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Measured: From Cycle 1 Day 1 to End of Treatment Visit (up to 3.3 years). A cycle is defined as a 28-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start12 Oct 2026
- Primary completion14 Sep 2029 (estimated)
- Study completion2 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771439
- Sponsor's protocol ID
- EFC22965
- Other IDs
- 2026-525913-30
- Status last verified
- Nov 2026
- First submitted
- 4 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group, Phase 3, Randomized, Open-label, 2-arm Study to Demonstrate the Superiority of Belumosudil Versus Best Available Therapy (BAT) in Participants at Least 12 Years of Age With Chronic Graft Versus Host Disease (cGVHD) Refractory to or Recurrent After 2 to 5 Prior Lines of Systemic Therapy
- ClinicalTrials.gov ID
- NCT07771439
- Acronym / sponsor ID
- EFC22965
- Conditions
- Chronic Graft Versus Host Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- 14 Sep 2029 (estimated)
- Study completion
- 2 Mar 2032 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation. The study will target patients post-ruxolitinib treatment, except where Investigators deemed ruxolitinib treatment for cGVHD not suitable. In the BAT arm, the study doctor will select one BAT based on clinical judgement, local availability etc. prior to randomization.
Participants randomized to the BAT arm will have the option to cross-over to open-label belumosudil treatment upon meeting predefined criteria.
Study details include:
- The study duration will be defined as 3 years from LPI.
- Individual participant duration on study will consist of:
- Up to 28 days for screening.
- Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD (except change from BAT to belumosudil during the cross-over), experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first.
- Thirty days of post treatment safety follow-up.
- Follow-up for cGVHD status as applicable.
- Long-term follow-up until death or end of study, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belumosudil | Experimental | Drug: BelumosudilParticipants will receive belumosudil |
| best available therapy(BAT) | Other | Other: Best available therapy (BAT)Participants will receive BAT based on the Investigator's judgment |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Participant must be at least 12 years of age at the time of signing the informed consent.
- Participants who have undergone allo-HCT.
- Participants with active moderate to severe cGVHD at the time of enrollment, defined using the NIH Consensus diagnosis and staging criteria for which the physician believes a new line of systemic therapy is required.
- Participant receiving systemic CNI and/or CS must be on a stable dose/regimen (prednisone equivalent <1 mg/kg/day for CS) for at least 2 weeks prior to randomization.
- cGVHD is refractory to, or has recurred following, at least 2 prior lines of systemic treatment. Participants must have received a minimum of 2 and a maximum of 5 prior systemic therapies for cGVHD.
Key exclusion criteria (24 listed)
- Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease or post-transplant lymphoproliferative disease after most recent allo-HCT.
- Participants who meet any of the following criteria regarding systemic cGVHD treatments:
- Ruxolitinib must be tapered and discontinued within 14 days following the first dose of belumosudil or BAT (allowing for a maximum overlap period of up to 14 days with belumosudil or BAT treatment).
- No dose increases of ruxolitinib are permitted from 14 days prior to the date of randomization until permanent discontinuation of ruxolitinib (dose reductions and discontinuations are permitted during this period).
- Note: Topical and organ-specific treatment for cGVHD and other supportive agents are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelumosudilAlso: SAR445761Pharmaceutical form:Tablet-Route of administration:oral | Drug | Belumosudil |
| Best available therapy (BAT)Participants will receive BAT based on the Investigator's judgment | Other | best available therapy(BAT) |
Primary outcome
Overall response rate
Time frame: at week 24
Overall response rate at 24 weeks defined as the proportion of participants who achieve an overall response (PR or CR) without the requirement of new systemic therapy as per NIH consensus response criteria (2014) at Week 24.
17 secondary outcomes
Time from the date of randomization to the date of start of new systemic treatment for cGVHD, relapse or recurrence of underlying disease, or death, whichever occurs first.
Time frame: Until the end of study, up to approximately 3 years from Last Participant In
Proportion of participants achieving at least 6-point reduction from baseline in the modified Lee cGVHD Symptom Scale score at Week 24.
Time frame: at 24 week
Proportion of participants who achieve an overall response (CR or PR) within up to 24 weeks and without the requirement of new systemic therapy as per NIH consensus response criteria (2014).
Time frame: up to 24 weeks
Proportion of participants who achieve an overall response (CR or PR) based on NIH consensus response criteria (2014) at any time until start of new systemic therapy for cGVHD.
Time frame: Until the end of study, up to approximately 3 years from Last Participant In
The time from first response of PR or CR until documented progression, new systemic treatment for cGVHD, or death, whichever occurs first.
Time frame: Until the end of study, up to approximately 3 years from Last Participant In
Time from randomization to the first response (either CR or PR) per NIH consensus response criteria (2014) for cGVHD.
Time frame: Until the end of study, up to approximately 3 years from Last Participant In
Time from the date of randomization to the date of starting a new systemic therapy for cGVHD.
Time frame: Until the end of study, up to approximately 3 years from Last Participant In
Proportion of participants who achieve CR or PR based on NIH consensus criteria (2014) at any time point in each involved organ and before the start of new systemic therapy for cGVHD.
Time frame: Until the end of study, up to approximately 3 years from Last Participant In
The time from the date of randomization to the date of death from any cause.
Time frame: Until the end of study, up to approximately 3 years from Last Participant In
Proportion of participants with >50% reduction from baseline in daily CS dose at Week 24.
Time frame: at Week 24
Proportion of participants with discontinuation of CS at Week 24.
Time frame: at Week 24
Proportion of participants with >50% reduction from baseline in daily CNI dose at Week 24.
Time frame: at Week 24
Proportion of participants with discontinuation of CNI at Week 24.
Time frame: at Week 24
Incidence of TEAEs, SAEs, and AESIs.
Time frame: From first dose of study treatment until 30 days after last dose (up to 3.3 years)
The cumulative incidence of relapse or recurrence of the underlying disease at any time during the study.
Time frame: Until the end of study, up to approximately 3 years from Last Participant In
Belumosudil plasma concentrations.
Time frame: at Cycle 1 Day 15, Cycle 2 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. A cycle is defined as a 28-day period
Change from baseline in SF-36v2 domain scores and composite Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Time frame: From Cycle 1 Day 1 to End of Treatment Visit (up to 3.3 years). A cycle is defined as a 28-day period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- For EU sites click here and navigate to 'Locations and contact points'Link provided by the sponsor.
- EFC22965 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Belumosudil and Best available therapy (BAT) in people with Chronic Graft Versus Host Disease, run by Sanofi at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: at week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.