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

Study on Investigational Treatment for Chronic Lung Allograft Dysfunction in Adults

Recruiting
18 years or above
All
Phase 3
180 participants needed
1 Location

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lung Transplant Rejection
  • Age: 18 years or above
  • Gender: All

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.

This study investigates chronic lung allograft dysfunction. It includes adult participants who have had a bilateral lung transplant.

This study evaluates the effectiveness and safety of an investigational medication. It is compared with a placebo, and participants also receive standard treatments.

  • Who can participate: Adults who are at least 18 years old and have had a bilateral lung transplant more than a year ago can participate. They must have chronic lung allograft dysfunction at Stage 1 or 2 and have been treated with azithromycin for at least 8 weeks.
  • Study details: Participants will take the investigational medication or a placebo along with their standard treatment. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines and visits: The study will last up to 31 weeks for participants not entering the OLE period and up to 57 weeks for those entering the OLE period. The study requires up to 10 visits for participants not entering the OLE period and up to 16 visits for those entering the OLE period.
Updated on 11 Jun 2026. Study ID: NCT06082037

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