Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Effectiveness of Belumosudil and Azithromycin for Adults with Chronic Lung Rejection After Lung Transplant

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as chronic lung allograft dysfunction (CLAD), which can occur after a person has received a lung transplant. The study is testing a treatment called belumosudil, which is taken as a tablet. The purpose of the study is to evaluate how effective belumosudil is in improving lung function in adults who have developed CLAD after a lung transplant. Participants in the study will be randomly assigned to receive either belumosudil or a placebo, which is a tablet that looks like the treatment but does not contain the active medicine.

During the study, participants will take the tablets by mouth. The study will be conducted in two parts: an initial phase where participants will not know if they are receiving belumosudil or the placebo, followed by an open-label phase where all participants will receive belumosudil. The study will last for several months, and participants will have regular check-ups to monitor their lung function and overall health. Lung function will be measured using a test called forced expiratory volume in 1 second (FEV1), which assesses how much air a person can exhale in one second.

Participants in the study will have already been treated with another medication called azithromycin for at least eight weeks before starting the trial. The study aims to see if belumosudil can help improve lung function and slow down the progression of CLAD. Throughout the study, researchers will also monitor for any side effects or adverse events to ensure the safety of the participants. The results of this study could provide valuable information about the potential benefits of belumosudil for people with CLAD following a lung transplant.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including being at least one year post bilateral lung transplantation and having chronic lung allograft dysfunction (CLAD) Stage 1 or 2.

    Participants must have been on azithromycin treatment for at least 8 weeks prior to joining the study.

  2. Step 2

    Randomization and initial treatment

    Participants are randomly assigned to receive either the study medication, belumosudil, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

    The medication is administered orally in the form of film-coated tablets.

  3. Step 3

    Treatment period

    The primary treatment period lasts for 26 weeks. During this time, lung function is monitored through tests measuring forced expiratory volume in 1 second (FEV1).

    Participants continue to take the assigned medication as directed throughout this period.

  4. Step 4

    Evaluation of primary outcomes

    The main goal is to assess the percent change in FEV1 from the start of the study to Week 26.

    Additional evaluations include the response rate, defined as the proportion of participants with a decline in FEV1 of 10% or less at Week 26 compared to baseline.

  5. Step 5

    Evaluation of secondary outcomes

    Secondary outcomes include changes in lung function, exercise capacity, and quality of life measures.

    Participants' health and any adverse events are monitored throughout the study.

  6. Step 6

    Open-label extension

    After the initial 26-week period, participants may enter an open-label extension phase where all receive the study medication, belumosudil.

    This phase allows for continued monitoring of lung function and overall health.

Who can join the trial?

6 criteria

  • The participant must be at least 1 year past a **bilateral lung transplantation** at the time of screening. This means they have received two new lungs.
  • The participant must have **CLAD Stage 1 or 2**. CLAD stands for Chronic Lung Allograft Dysfunction, which is a condition affecting the lungs after a transplant. Stage 1 or 2 means the condition is in its early stages.
  • The participant's **FEV1** (Forced Expiratory Volume in 1 second) should be between more than 50% and 80% of their best lung function after the transplant, both at the time of screening and when they are randomly assigned to a group in the study. FEV1 is a measure of how much air a person can forcefully exhale in one second.
  • The participant must have taken **azithromycin** for at least 8 weeks before being randomly assigned to a group in the study. Azithromycin is a type of antibiotic, and they should have taken at least 250 mg per day, at least 3 times a week, after being diagnosed with CLAD.
  • Both male and female participants are eligible to join the study.
  • The study includes participants from vulnerable populations, which means it considers people who might need extra care or protection.

Who cannot join the trial?

6 criteria

  • Patients who have not undergone a **bilateral lung transplantation**. This means both lungs have been transplanted.
  • Patients who do not have **Stage 1 or 2 CLAD**. CLAD stands for Chronic Lung Allograft Dysfunction, which is a condition affecting the lungs after a transplant.
  • Patients who are not experiencing **lung transplant rejection**. This is when the body’s immune system attacks the transplanted lung.
  • Patients who are not within the specified **age range**. The study is for certain age groups only.
  • Patients who are not part of the specified **clinical trial groups**. This refers to specific categories or groups of patients that the study is focusing on.
  • Patients who are not considered part of a **vulnerable population**. This term refers to groups of people who might be at higher risk or need special protection in research.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Belumosudil is an oral medication being studied for its potential to improve lung function in adults who have chronic lung allograft dysfunction (CLAD) after receiving a bilateral lung transplant. The trial aims to see if belumosudil can help maintain or improve the ability to breathe by measuring the forced expiratory volume in one second (FEV1), which is a common test to assess lung function.

What is already known about the treatment

Belumosudil – This medication is administered orally and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating chronic lung allograft dysfunction (CLAD) following bilateral lung transplantation. It is primarily indicated for preventing lung transplant rejection. Belumosudil works by inhibiting a specific enzyme involved in immune response regulation, which helps reduce inflammation and prevent organ rejection. It is classified as an immunosuppressant.

Investigated diseases

Lung transplant rejection – This condition occurs when the body's immune system attacks the transplanted lung, viewing it as a foreign object. It can happen at any time after the transplant, but is most common in the first year. The rejection process can lead to inflammation and damage to the lung tissue, affecting its function. Symptoms may include shortness of breath, cough, and a decrease in lung function. Over time, if not managed, it can lead to chronic lung allograft dysfunction, which further impairs lung function. Monitoring and managing this condition is crucial to maintaining the health of the transplanted lung.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503462-23-00Protocol codeEFC17801Estimated enrolment227 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.