NCT06082037 · Sanofi
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
(ROCKaspire)
What this study is about
This where neither patients nor doctors know which treatment is given, randomly assigned, compared against an inactive treatment, multinational, conducted at multiple hospitals, parallel-group, Phase 3, 2-treatment group$1, study will investigate the effectiveness 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
View original scientific description
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.
Interventions
DRUG
Belumosudil
Tablet, Oral
DRUG
Azithromycin
Depends on pharmaceutical presentation, Oral
DRUG
Placebo
Tablet, Oral
Primary outcome measures
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline to Week 26
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant ≥1 year post bilateral lung transplantation at the time of screening
- Participants presenting with CLAD Stage 1 or 2: 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
- 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
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Los Angeles, California
- Stanford, California
- Jacksonville, Florida
- Miami, Florida
- Orlando, Florida
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Maywood, Illinois
- Iowa City, Iowa
And 15 more locations — see the full list below.
Collaborators
Meiji Seika Pharma Co., Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations