Belumosudil for Chronic Lung Allograft Dysfunction

This study is testing a medication called belumosudil to see how well it works for adults who have chronic lung allograft dysfunction (CLAD), a type of lung transplant rejection. You might be able to join if you are at least 18 years old, had a bilateral lung transplant over a year ago, and have CLAD that is still progressing despite taking azithromycin. The study will compare belumosudil to a placebo (an inactive pill) to see if belumosudil can improve your lung function. We'll measure this by looking at changes in your forced expiratory volume in 1 second (FEV1) over 26 weeks. The study's current status is unclear, and it plans to enroll 180 participants.

Study design
This is a Phase 3, double-blind, randomized study comparing belumosudil to a placebo, both given with azithromycin and standard care. It plans to enroll 180 participants.
What's involved
You would take either belumosudil or a placebo, along with azithromycin. The study duration is up to 31 weeks, or up to 57 weeks if you enter an extension period.
Compensation
Not stated in the trial record.
Follow-up
Your lung function will be measured from the start of the study up to Week 26 to see how it changes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06082037

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Sanofi
~180 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:BelumosudilAzithromycinPlacebo

At a glance

Recruiting sites
79 of 79 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
Measured over Baseline to Week 26
Lung Transplant Rejection

NCT06082037

Where you'd take part

This study runs at 79 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Azienda Ospedaliera Universitaria Senese UOC Malattie Respiratorie e Trapianto Polmonare-Site Number : 3800002

    Siena, Italystudy coordinator listed

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano-Site Number : 3800001

    Milan, Milano, Italystudy coordinator listed

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo-Site Number : 3800003

    Pavia, Italystudy coordinator listed

    Recruiting

  • IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)-Site Number : 3800004

    Palermo, Italystudy coordinator listed

    Recruiting

  • AdventHealth Orlando- Site Number : 8400023

    Orlando, Floridano site contact published

    Recruiting

  • Baylor College of Medicine- Site Number : 8400024

    Houston, Texasno site contact published

    Recruiting

  • Brigham & Women's Hospital- Site Number : 8400016

    Boston, Massachusettsno site contact published

    Recruiting

  • Cleveland Clinic - Cleveland- Site Number : 8400005

    Cleveland, Ohiono site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Clinical Sciences & Operations · STUDY_DIRECTOR · Sanofi
Trial Transparency email recommended (Toll free number for US & Canada)
Email the study team

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Eligibility criteria

Inclusion

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

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
  • Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)Baseline to Week 26