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

Study on the Efficacy and Safety of an Investigational Medication for Lung Transplant Patients with CLAD

Recruiting
18 years or above
All
Phase 3
180 participants needed
9 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, Lung Transplant Rejections
  • 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 03 Dec 2024. Study ID: NCT06082037

This study investigates the effectiveness and safety of an investigational medication compared to a placebo in people who have had a lung transplant. The purpose is to see if the investigational medication can help with a condition called CLAD, which stands for chronic lung allograft dysfunction. CLAD is a problem that can happen after a lung transplant where the lungs do not work as well as they should. All participants will continue their regular treatment with azithromycin and other standard medicines to prevent the body from rejecting the new lungs.

Participants in the study will be divided into two groups, called study arms. One group will receive the investigational medication, and the other group will receive a placebo, which is a substance that looks like the investigational medication but does not contain any active medicine. This will be done to compare the effects of the investigational medication with no treatment. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the investigational medication and who is receiving the placebo until the study ends.

  • Who can participate: Adults who are at least 18 years old and have had a bilateral lung transplant at least 1 year ago can participate. They must have CLAD and have been on azithromycin for at least 8 weeks. Participants should not have lung problems due to other causes or have received other treatments for CLAD.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. They will continue their usual treatment with azithromycin and other standard medicines to prevent organ rejection. The study is double-blind, so neither participants nor doctors will know who is receiving the investigational medication until the study is completed.

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