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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

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

Obara Kentaro

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

clinical-trials-jp@sanofi.com

Clinical Study Unit

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

+81-3-6301-3670

clinical-trials-jp@sanofi.com

Recruiting

Mar. 09, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.

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.

Both

Lung transplant rejection

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

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

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.

+81-3-5800-8743

Feb. 03, 2026

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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