A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Investigation of an Investigational Medication for Lung Function Decline in Transplant Recipients
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 in treating chronic lung allograft dysfunction (CLAD) in adults who have had a lung transplant. Participants in this study must have had their transplant at least a year ago and must be experiencing progression of CLAD despite azithromycin therapy.
Participants will receive either the investigational medication or a placebo, in addition to their regular treatment, which includes azithromycin and other immunosuppressive drugs. The study uses a double-blind method, meaning neither the participants nor the researchers know who is receiving the investigational medication. This helps to ensure unbiased results.
- Who can participate: Adults 18 years or older who are at least one year post-bilateral lung transplantation and have CLAD Stage 1 or 2 can participate. They must have had azithromycin treatment for at least 8 weeks prior to joining the study.
- Study details: Participants will take either the investigational medication or a placebo, alongside their current treatment. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
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