A Phase 3 interventional study of Belumosudil and Azithromycin in Lung Transplant Rejection, sponsored by Sanofi. Recruiting at 85 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy.
Study details include:
The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE.
The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE.
The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE.
For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.
Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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.
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.
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 200 mg belumosudil orally once daily
Drug: Belumosudil · Drug: Azithromycin
Participants will receive placebo orally once daily
Drug: Azithromycin · Drug: Placebo
Tablet, Oral
Also known as: REZUROCK
Depends on pharmaceutical presentation, Oral
Tablet, Oral
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline to Week 26
Response rate at Week 26
Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in FEV1
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in percent predicted FEV1
Time frame: Baseline to Week 26
Percent change from baseline to Week 26 in forced vital capacity (FVC)
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in FVC
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in percent predicted FVC
Time frame: Baseline to Week 26
Time to CLAD progression during the double-blind treatment period
Defined as the first of the following events: \>10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death
Time frame: Baseline to Week 26
Time to re-transplantation or death
Time frame: Up to 7 days after the administration of last dose of study drug
Percent change from baseline to Week 26 in 6-minute walk distance
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in 6-minute walk distance
Time frame: Baseline to Week 26
Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)
Total score and scores by domain
Time frame: Baseline to Week 26
Change from baseline to Week 26 in EQ-5D-5L
Visual analogue scale and individual dimensions
Time frame: Baseline to Week 26
Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile V2.1 (domain scores)
Time frame: Baseline to Week 26
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions
Time frame: Up to 7 days after the administration of last dose of study drug
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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
Started Oct 2023 (actual). Primary completion is estimated for Jan 2029, 63 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Belumosudil