Testing the effectiveness of belumosudil for treating lung transplant rejection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial is a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of belumosudil tablets in adult participants with chronic lung allograft dysfunction (CLAD) who are at least one year post bilateral lung transplant. Participants will receive either belumosudil or a placebo, alongside azithromycin and standard immunosuppressive therapy. The study will last up to 31 weeks for those not entering the open-label extension period, with multiple visits scheduled throughout the trial. The goal is to determine if belumosudil can improve lung function in patients experiencing progressive CLAD despite existing treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham- Site Number : 8400026
  Birmingham, Alabama, United States Recruiting
• St. Joseph's Hospital and Medical Center- Site Number : 8400019
  Phoenix, Arizona, United States Recruiting
• University of California Los Angeles Medical Center- Site Number : 8400020
  Los Angeles, California, United States Recruiting
• Stanford University Medical Center- Site Number : 8400008
  Stanford, California, United States Recruiting
• Mayo Clinic in Florida- Site Number : 8400031
  Jacksonville, Florida, United States Recruiting
• Jackson Memorial Hospital- Site Number : 8400030
  Miami, Florida, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free number for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hyperpolarized xenon-129 MRI signatures to detect and manage acute cellular rejection after lung transplant

  We will see if hyperpolarized xenon-129 MRI can detect early acute cellular rejection in recent lung transplant recipients and guide targeted bronchoscopic sampling.

  Recruiting Phase 2 University of Virginia · Charlottesville, Virginia · NCT07046910

• Comparing biopsy methods for lung transplant rejection diagnosis

  This study tests which of two methods for taking lung tissue samples works better for diagnosing rejection in lung transplant patients.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT06824402

• Research on improving outcomes for lung transplant donors and recipients

  This study is trying to see how different donor and medical practices affect the health of lung transplant patients and donors, while also looking for blood markers that might predict complications after the surgery.

  Recruiting at 19 sites Duke University · Los Angeles, California and 18 other locations · NCT06399302

• Evaluating extracorporeal photopheresis for subclinical lung transplant rejection

  This study is testing if a light-based treatment called extracorporeal photopheresis can help lung transplant patients who have early signs of rejection feel better and improve their health.

  Recruiting Medical University of Vienna · Vienna and 6 other locations · NCT06112951

• Identifying biomarkers for lung transplant dysfunction

  This study is trying to find specific markers in the body that can help doctors understand and manage problems after lung transplants for patients at Foch Hospital.

  Recruiting Hopital Foch · Suresnes · NCT04837339

• Evaluating new diagnostic methods for lung transplant rejection

  This study is testing a new diagnostic tool to see if it can better identify lung transplant rejection in patients who are having problems with their transplanted lungs.

  Recruiting at 4 sites University of Alberta · Phoenix, Arizona and 10 other locations · NCT02812290

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.