Condition: Lung Transplant Rejection · Sponsor: Sanofi
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.
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free number for US & Canada) · 800-633-1610 · contact-us@sanofi.com
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham- Site Number : 8400026 | Birmingham, Alabama, United States | Recruiting |
| St. Joseph's Hospital and Medical Center- Site Number : 8400019 | Phoenix, Arizona, United States | Recruiting |
| University of California Los Angeles Medical Center- Site Number : 8400020 | Los Angeles, California, United States | Recruiting |
| Stanford University Medical Center- Site Number : 8400008 | Stanford, California, United States | Recruiting |
| Mayo Clinic in Florida- Site Number : 8400031 | Jacksonville, Florida, United States | Recruiting |
| Jackson Memorial Hospital- Site Number : 8400030 | Miami, Florida, United States | Recruiting |
| AdventHealth Orlando- Site Number : 8400023 | Orlando, Florida, United States | Recruiting |
| Tampa General Hospital - Tampa - General Circle- Site Number : 8400015 | Tampa, Florida, United States | Recruiting |
| Emory University Hospital- Site Number : 8400027 | Atlanta, Georgia, United States | Recruiting |
| Northwestern University- Site Number : 8400003 | Chicago, Illinois, United States | Recruiting |
| Loyola University Medical Center- Site Number : 8400025 | Maywood, Illinois, United States | Recruiting |
| University of Iowa- Site Number : 8400032 | Iowa City, Iowa, United States | Recruiting |
+ 67 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06082037