A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Study of an Investigational Medication for Chronic Lung Allograft Dysfunction
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 adult participants with chronic lung allograft dysfunction (CLAD). Participants in this study must have had a bilateral lung transplant at least one year prior and must be experiencing progressive CLAD despite being on azithromycin therapy. The investigational medication and placebo will be given along with azithromycin and standard immunosuppressive treatments.
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. This is a double-blind study, meaning neither the participants nor the researchers will know who is receiving the investigational medication or the placebo. Participants will undergo regular assessments to monitor lung function and overall health. The study includes several visits to the research center for these assessments.
- Who can participate: Participants must be at least 18 years old and have undergone bilateral lung transplantation at least one year prior to the study. They should have CLAD Stage 1 or 2 with specific lung function criteria and must have been on azithromycin therapy for at least 8 weeks.
- Study details: Participants will take either the investigational medication or a placebo, which looks like the investigational medicine but does not contain any medicine. They will continue their standard azithromycin and immunosuppressive treatments. Regular assessments will be conducted to evaluate the effectiveness and safety of the treatments.
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