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.
Lung Transplant Rejection
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.
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
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University of Alabama at Birmingham- Site Number : 8400026, Birmingham, Alabama, United States, 35233
St. Joseph's Hospital and Medical Center- Site Number : 8400019, Phoenix, Arizona, United States, 85013
University of California Los Angeles Medical Center- Site Number : 8400020, Los Angeles, California, United States, 90095
Stanford Hospital- Site Number : 8400008, Stanford, California, United States, 94305
Mayo Clinic Hospital Jacksonville- Site Number : 8400031, Jacksonville, Florida, United States, 32224
Jackson Memorial Hospital- Site Number : 8400030, Miami, Florida, United States, 33136
AdventHealth Orlando- Site Number : 8400023, Orlando, Florida, United States, 32803
Tampa General Hospital - Tampa - General Circle- Site Number : 8400015, Tampa, Florida, United States, 33606
Emory University Hospital- Site Number : 8400027, Atlanta, Georgia, United States, 30324
Northwestern University- Site Number : 8400003, Chicago, Illinois, United States, 60611
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Sanofi,
Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi
2028-06-02