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.
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
At a glance
Conditions
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.
Study leadership
- Clinical Sciences & Operations · STUDY_DIRECTOR · Sanofi
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)Baseline to Week 26