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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Lung Transplant Rejection

In brief

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.

Key facts

Study ID

NCT06082037

Run by

Sanofi

People needed

180

Starts

2023-10-10

Expected to finish

2030-10-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• St. Joseph's Hospital and Medical Center- Site Number : 8400019 — Phoenix, Arizona, United States (enrolling)
• University of California Los Angeles Medical Center- Site Number : 8400020 — Los Angeles, California, United States (enrolling)
• Stanford University Medical Center- Site Number : 8400008 — Stanford, California, United States (enrolling)
• Mayo Clinic in Florida- Site Number : 8400031 — Jacksonville, Florida, United States (enrolling)
• Jackson Memorial Hospital- Site Number : 8400030 — Miami, Florida, United States (enrolling)
• AdventHealth Orlando- Site Number : 8400023 — Orlando, Florida, United States (enrolling)
• Tampa General Hospital - Tampa - General Circle- Site Number : 8400015 — Tampa, Florida, United States (enrolling)
• Emory University Hospital- Site Number : 8400027 — Atlanta, Georgia, United States (enrolling)
• Northwestern University- Site Number : 8400003 — Chicago, Illinois, United States (enrolling)
• Loyola University Medical Center- Site Number : 8400025 — Maywood, Illinois, United States (enrolling)
• University of Iowa- Site Number : 8400032 — Iowa City, Iowa, United States (enrolling)
• University of Maryland School of Medicine - Baltimore- Site Number : 8400009 — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins Hospital- Site Number : 8400034 — Baltimore, Maryland, United States (enrolling)
• Brigham & Women's Hospital- Site Number : 8400016 — Boston, Massachusetts, United States (enrolling)
• University of Michigan Health System - Ann Arbor- Site Number : 8400014 — Ann Arbor, Michigan, United States (enrolling)
• Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400010 — Grand Rapids, Michigan, United States (enrolling)
• NYU Perlmutter Cancer Center - Energy Building- Site Number : 8400001 — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai- Site Number : 8400037 — New York, New York, United States (enrolling)
• Columbia University Irving Medical Center- Site Number : 8400002 — New York, New York, United States (enrolling)
• Montefiore Medical Center - Moses Campus- Site Number : 8400036 — The Bronx, New York, United States (enrolling)
• Duke University Medical Center- Site Number : 8400017 — Durham, North Carolina, United States (enrolling)
• Cleveland Clinic - Cleveland- Site Number : 8400005 — Cleveland, Ohio, United States (enrolling)
• The Ohio State University- Site Number : 8400028 — Columbus, Ohio, United States (enrolling)
• Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006 — Philadelphia, Pennsylvania, United States (enrolling)
• University of Alabama at Birmingham- Site Number : 8400026 — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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