A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Investigational Research Study for Chronic Lung Allograft Dysfunction Post Lung Transplant
Study Overview
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Lung Transplant Rejection
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Age: 18 years or above
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Gender: All
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
This study investigates the effectiveness and safety of an investigational medication compared to a placebo for treating chronic lung allograft dysfunction (CLAD) in adults. Participants will have already undergone a bilateral lung transplant and will be receiving a standard treatment regimen including azithromycin and immunosuppression therapies.
Participants in the study will be randomly assigned to one of two study arms: one receiving the investigational medication and the other receiving a placebo. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the investigational medication or the placebo. Participants will continue with their standard care regimen while being monitored for changes in lung function and overall health.
- Who can participate: Adults who are at least one year post bilateral lung transplantation, aged 18 or older, and have CLAD Stage 1 or 2 with FEV1 between 50% and 80% of their post-transplant baseline are eligible. They must have been on azithromycin therapy for at least 8 weeks prior to the study.
- Study details: Participants will continue their standard treatment regimen and will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
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