A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Study of an Investigational Study Drug for Chronic Lung Allograft Dysfunction After 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The purpose of this research study is to learn about the effects and safety of an investigational study drug for adults who have chronic lung allograft dysfunction (CLAD), a long-term worsening of lung function after a lung transplant. This study is for people who are at least one year after a double (bilateral) lung transplant and whose CLAD is getting worse even though they have been taking azithromycin.
Participants will receive either the investigational study drug or a placebo. A placebo looks like the investigational study drug but does not contain active medication. Both are given along with azithromycin and the person’s usual anti-rejection (immunosuppression) medicines.
Who can participate:
Adults with chronic lung allograft dysfunction after a double lung transplant may be able to participate if they:
- Are 18 years old or older
- Are at least one year after a double (bilateral) lung transplant
- Have CLAD stage 1 or 2 (mild to moderate loss of lung function compared with their best level after transplant)
- Have taken azithromycin for at least eight weeks before joining the study
Study timeline and visits:
Participation lasts up to 31 weeks for people who do not continue into a longer study period, and up to 57 weeks for people who do. There will be up to 10 visits for people who do not continue into a longer study period, and up to 16 visits for people who do. Some participants may continue longer, with visits about every 12 weeks.
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