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A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction

RecruitingPhase 3Ages 18 Years - anyAllSanofi
NCT06082037 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Belumosudil
  • Azithromycin
  • Placebo
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Where

82 sites
University of Alabama at Birmingham- Site Number : 8400026
Birmingham, United States
St. Joseph's Hospital and Medical Center- Site Number : 8400019
Phoenix, United States
University of California Los Angeles Medical Center- Site Number : 8400020
Los Angeles, United States
Stanford University Medical Center- Site Number : 8400008
Stanford, United States
Mayo Clinic in Florida- Site Number : 8400031
Jacksonville, United States
Jackson Memorial Hospital- Site Number : 8400030
Miami, United States
AdventHealth Orlando- Site Number : 8400023
Orlando, United States
Tampa General Hospital - Tampa - General Circle- Site Number : 8400015
Tampa, United States

…and 74 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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