Status:
RECRUITING
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Lead Sponsor:
Sanofi
Conditions:
Lung Transplant Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 2 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06082037
Start Date
October 10 2023
End Date
June 2 2028
Last Update
December 9 2025
Active Locations (80)
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1
University of Alabama at Birmingham- Site Number : 8400026
Birmingham, Alabama, United States, 35233
2
St. Joseph's Hospital and Medical Center- Site Number : 8400019
Phoenix, Arizona, United States, 85013
3
University of California Los Angeles Medical Center- Site Number : 8400020
Los Angeles, California, United States, 90095
4
Stanford University Medical Center- Site Number : 8400008
Stanford, California, United States, 94305