A study to test how effective belumosudil tablets are for treating adult participants with chronic lung allograft dysfunction

A randomized, double-blind, placebo-controlled, parallel group, Phase 3 study, followed by open-label extensions, to evaluate the efficacy of oral belumosudil in adult participants with chronic lung allograft dysfunction (CLAD) following bilateral lung transplantation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250734

Enrollment

180

Registered

2026-02-13

Start date

2026-03-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung transplant rejection

Interventions

Drug: Belumosudil (REZUROCK) Pharmaceutical form: Tablet, Route of administration: Oral Drug: Azithromycin Pharmaceutical form: Depends on pharmaceutical presentation, Route of administration: Ora

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participant >=1 year post bilateral lung transplantation at the time of screening. - Participants presenting with CLAD Stage 1 or 2: Forced expiratory volume in 1 second (FEV1) from >50% to 80% of post-transplant baseline at screening and at randomization. - Participants who have received at least 8 weeks of azithromycin (>=250 mg/day, at least 3 times a week) prior to randomization.

Exclusion criteria

Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - FEV1 A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia.

Design outcomes

Primary

Measure	Time frame
1. Percent change from baseline to Week 26 in FEV1 [Time Frame: Baseline to Week 26]	—

Secondary

Measure	Time frame
1. Response rate at Week 26 [Time Frame: Baseline to Week 26] Defined as the proportion of participants with 10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death. 8. Time to re-transplantation or death [Time Frame: Up to 7 days after the administration of last dose of study drug] 9. Percent change from baseline to Week 26 in 6-minute walk distance [Time Frame: Baseline to Week 26] 10. Absolute change from baseline to Week 26 in 6-minute walk distance [Time Frame: Baseline to Week 26] 11. Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ) [Time Frame: Baseline to Week 26] Total score and scores by domain. 12. Change from baseline to Week 26 in European Quality of Life Group Questionnaire with 5 dimensions and 5 levels (EQ-5D-5L) [Time Frame: Baseline to Week 26] Visual analogue scale and individual dimensions. 13. Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile version 2.1 [Time Frame: Baseline to Week 26] PROMIS-29 profile V2.1 (domain scores). 14. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Time Frame: Up to 7 days after the administration of last dose of study drug] Treatment-emergent adverse events (TEAEs), SAEs, adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions.	—

Measure

Time frame

1. Response rate at Week 26 [Time Frame: Baseline to Week 26] Defined as the proportion of participants with 10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death. 8. Time to re-transplantation or death [Time Frame: Up to 7 days after the administration of last dose of study drug] 9. Percent change from baseline to Week 26 in 6-minute walk distance [Time Frame: Baseline to Week 26] 10. Absolute change from baseline to Week 26 in 6-minute walk distance [Time Frame: Baseline to Week 26] 11. Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ) [Time Frame: Baseline to Week 26] Total score and scores by domain. 12. Change from baseline to Week 26 in European Quality of Life Group Questionnaire with 5 dimensions and 5 levels (EQ-5D-5L) [Time Frame: Baseline to Week 26] Visual analogue scale and individual dimensions. 13. Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile version 2.1 [Time Frame: Baseline to Week 26] PROMIS-29 profile V2.1 (domain scores). 14. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Time Frame: Up to 7 days after the administration of last dose of study drug] Treatment-emergent adverse events (TEAEs), SAEs, adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions.

—

Countries

Australia, Austria, Belgium, Canada, China, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, United States

Contacts

Public ContactUnit Clinical

Sanofi K.K.

clinical-trials-jp@sanofi.com+81-3-6301-3670

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026