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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Lung transplant rejection
Date of first enrollment	09/03/2026
Target sample size	180
Countries of recruitment	Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,China,Japan,Czechia,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Drug: Belumosudil (REZUROCK) Pharmaceutical form: Tablet, Route of administration: Oral Drug: Azithromycin Pharmaceutical form: Depends on pharmaceutical presentation, Route of administration: Oral Drug: Placebo Pharmaceutical form: Tablet, Route of administration: Oral Study Arms: - Experimental: Belumosudil + Azithromycin Participants will receive 200 mg belumosudil orally once daily - -Interventions: Belumosudil, Azithromycin - Placebo Comparator: Placebo + Azithromycin Participants will receive placebo orally once daily - - Interventions: Placebo, Azithromycin

Outcome(s)

Primary Outcome

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

Secondary Outcome

1. Response rate at Week 26 [Time Frame: Baseline to Week 26] Defined as the proportion of participants with <=10% decline in FEV1 at Week 26 compared with baseline. 2. Absolute change from baseline to Week 26 in FEV1 [Time Frame: Baseline to Week 26] 3. Absolute change from baseline to Week 26 in percent predicted FEV1 [Time Frame: Baseline to Week 26] 4. Percent change from baseline to Week 26 in forced vital capacity (FVC) [Time Frame: Baseline to Week 26] 5. Absolute change from baseline to Week 26 in FVC [Time Frame: Baseline to Week 26] 6. Absolute change from baseline to Week 26 in percent predicted FVC [Time Frame: Baseline to Week 26] 7. Time to CLAD progression during the double-blind treatment period [Time Frame: Baseline to Week 26] 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. 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.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude criteria	Participants are excluded from the study if any of the following criteria apply: - FEV1 <=50% of the post-transplant baseline value (CLAD 3 and 4). - Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia.