A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
- Conditions
- Lung Transplant Rejection
- Interventions
- Registration Number
- NCT06082037
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Belumosudil + Azithromycin Azithromycin Participants will receive 200 mg belumosudil orally once daily Belumosudil + Azithromycin Belumosudil Participants will receive 200 mg belumosudil orally once daily Placebo + Azithromycin Azithromycin Participants will receive placebo orally once daily Placebo + Azithromycin Placebo Participants will receive placebo orally once daily
- Primary Outcome Measures
Name Time Method Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1) Baseline to Week 26
- Secondary Outcome Measures
Name Time Method Change from baseline to Week 26 in EQ-5D-5L Baseline to Week 26 Visual analogue scale and individual dimensions
Response rate at Week 26 Baseline to Week 26 Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline
Absolute change from baseline to Week 26 in FEV1 Baseline to Week 26 Absolute change from baseline to Week 26 in percent predicted FEV1 Baseline to Week 26 Percent change from baseline to Week 26 in forced vital capacity (FVC) Baseline to Week 26 Absolute change from baseline to Week 26 in FVC Baseline to Week 26 Absolute change from baseline to Week 26 in percent predicted FVC Baseline to Week 26 Time to CLAD progression during the double-blind treatment period Baseline to Week 26 Defined as the first of the following events: \>10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death
Percent change from baseline to Week 26 in 6-minute walk distance Baseline to Week 26 Time to re-transplantation or death Up to 7 days after the administration of last dose of study drug Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1 Baseline to Week 26 Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile V2.1 (domain scores)
Number of participants with adverse events (AEs) and serious adverse events (SAEs) Up to 7 days after the administration of last dose of study drug Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions
Absolute change from baseline to Week 26 in 6-minute walk distance Baseline to Week 26 Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ) Baseline to Week 26 Total score and scores by domain
Trial Locations
- Locations (78)
University of Alabama at Birmingham- Site Number : 8400026
🇺🇸Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center- Site Number : 8400019
🇺🇸Phoenix, Arizona, United States
University of California Los Angeles Medical Center- Site Number : 8400020
🇺🇸Los Angeles, California, United States
Stanford Hospital- Site Number : 8400008
🇺🇸Stanford, California, United States
Mayo Clinic Hospital Jacksonville- Site Number : 8400031
🇺🇸Jacksonville, Florida, United States
Jackson Memorial Hospital- Site Number : 8400030
🇺🇸Miami, Florida, United States
AdventHealth Orlando- Site Number : 8400023
🇺🇸Orlando, Florida, United States
Tampa General Hospital - Tampa - General Circle- Site Number : 8400015
🇺🇸Tampa, Florida, United States
Emory University Hospital- Site Number : 8400027
🇺🇸Atlanta, Georgia, United States
Northwestern University- Site Number : 8400003
🇺🇸Chicago, Illinois, United States
Scroll for more (68 remaining)University of Alabama at Birmingham- Site Number : 8400026🇺🇸Birmingham, Alabama, United States