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

Investigation of an Investigational Medication for Progressive Lung Disease After Transplant

Recruiting
18 years or above
All
Phase 3
180 participants needed
5 Locations

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
  • Participants who have received at least 8 weeks of azithromycin

Exclusion Criteria:

  • Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection within 4 weeks of screening, airway stenosis, or tracheobronchomalacia
  • Participants who have received other treatments for CLAD

Updated on 16 Jan 2025. Study ID: NCT06082037

This study investigates the effects of an investigational medication compared to a placebo in people who have had a lung transplant and are experiencing a progressive condition called chronic lung allograft dysfunction (CLAD). CLAD is a condition that affects the lungs after a transplant, causing them to not work as well over time. Participants in this study must have already been treated with azithromycin, an antibiotic, but still show signs of CLAD progression.

Participants will be randomly assigned to one of two study arms. One arm will receive the investigational medication along with azithromycin and standard immunosuppressive treatment, while the other arm will receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine, along with azithromycin and standard immunosuppressive treatment. This study is double-blind, meaning neither participants nor researchers will know who receives the investigational medication or placebo.

  • Who can participate: Adults 18 years or older who are at least one year post bilateral lung transplant and have progressive CLAD despite azithromycin treatment can participate. Key eligibility includes having received at least 8 weeks of azithromycin and not having lung function decline due to non-CLAD causes.
  • Study details: Participants will take either the investigational medication or a placebo along with their usual treatments. This is a double-blind study, so neither participants nor researchers will know who is receiving the investigational medication. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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