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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT06082037

Registry updated: 2026-09-23
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Description

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.

Interventions

  • Belumosudil (Drug)
    Tablet, Oral
  • Azithromycin (Drug)
    Depends on pharmaceutical presentation, Oral
  • Placebo (Drug)
    Tablet, Oral

Eligibility criteria

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.

Conditions

Lung Transplant Rejection

Locations

  • University of Alabama at Birmingham- Site Number : 8400026 — Birmingham, Alabama, United States
  • St. Joseph's Hospital and Medical Center- Site Number : 8400019 — Phoenix, Arizona, United States
  • University of California Los Angeles Medical Center- Site Number : 8400020 — Los Angeles, California, United States
  • Stanford University Medical Center- Site Number : 8400008 — Stanford, California, United States
  • Mayo Clinic in Florida- Site Number : 8400031 — Jacksonville, Florida, United States
  • Jackson Memorial Hospital- Site Number : 8400030 — Miami, Florida, United States
  • AdventHealth Orlando- Site Number : 8400023 — Orlando, Florida, United States
  • Tampa General Hospital - Tampa - General Circle- Site Number : 8400015 — Tampa, Florida, United States
  • Emory University Hospital- Site Number : 8400027 — Atlanta, Georgia, United States
  • Northwestern University- Site Number : 8400003 — Chicago, Illinois, United States
  • Loyola University Medical Center- Site Number : 8400025 — Maywood, Illinois, United States
  • University of Iowa- Site Number : 8400032 — Iowa City, Iowa, United States
  • University of Maryland School of Medicine - Baltimore- Site Number : 8400009 — Baltimore, Maryland, United States
  • Johns Hopkins Hospital- Site Number : 8400034 — Baltimore, Maryland, United States
  • Brigham & Women's Hospital- Site Number : 8400016 — Boston, Massachusetts, United States
  • University of Michigan Health System - Ann Arbor- Site Number : 8400014 — Ann Arbor, Michigan, United States
  • Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400010 — Grand Rapids, Michigan, United States
  • NYU Perlmutter Cancer Center - Energy Building- Site Number : 8400001 — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai- Site Number : 8400037 — New York, New York, United States
  • Columbia University Irving Medical Center- Site Number : 8400002 — New York, New York, United States
  • Montefiore Medical Center - Moses Campus- Site Number : 8400036 — The Bronx, New York, United States
  • Duke University Medical Center- Site Number : 8400017 — Durham, North Carolina, United States
  • Cleveland Clinic - Cleveland- Site Number : 8400005 — Cleveland, Ohio, United States
  • The Ohio State University- Site Number : 8400028 — Columbus, Ohio, United States
  • Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006 — Philadelphia, Pennsylvania, United States
  • Temple University Hospital- Site Number : 8400007 — Philadelphia, Pennsylvania, United States
  • Vanderbilt University Medical Center- Site Number : 8400018 — Nashville, Tennessee, United States
  • University of Texas - Southwestern Medical Center- Site Number : 8400013 — Dallas, Texas, United States
  • Baylor College of Medicine- Site Number : 8400024 — Houston, Texas, United States
  • Houston Methodist Hospital- Site Number : 8400021 — Houston, Texas, United States
  • University Health System - San Antonio- Site Number : 8400035 — San Antonio, Texas, United States
  • University of Utah Medical Group- Site Number : 8400039 — Salt Lake City, Utah, United States
  • Inova Fairfax Hospital- Site Number : 8400004 — Falls Church, Virginia, United States
  • Investigational Site Number : 0360003 — Darlinghurst, New South Wales, Australia
  • Investigational Site Number : 0360001 — Brisbane, Queensland, Australia
  • Investigational Site Number : 0360002 — Murdoch, Western Australia, Australia
  • Investigational Site Number : 0400001 — Vienna, Austria
  • Investigational Site Number : 0560001 — Leuven, Belgium
  • Investigational Site Number : 0560002 — Yvoir, Belgium
  • Investigational Site Number : 1240002 — Edmonton, Alberta, Canada
  • Investigational Site Number : 1240001 — Vancouver, British Columbia, Canada
  • Investigational Site Number : 1240004 — Toronto, Ontario, Canada
  • Investigational Site Number : 1560004 — Beijing, China
  • Investigational Site Number : 1560002 — Chengdu, China
  • Investigational Site Number : 1560008 — Fuzhou, China
  • Investigational Site Number : 1560007 — Guangzhou, China
  • Investigational Site Number : 1560001 — Hangzhou, China
  • Investigational Site Number : 1560005 — Hefei, China
  • Investigational Site Number : 1560009 — Shanghai, China
  • Investigational Site Number : 1560003 — Wuxi, China
  • Investigational Site Number : 1560006 — Zhengzhou, China
  • Investigational Site Number : 2030002 — Olomouc, Czechia
  • Investigational Site Number : 2030001 — Prague, Czechia
  • Investigational Site Number : 2080001 — Copenhagen, Denmark
  • Investigational Site Number : 2460001 — Helsinki, Finland
  • Investigational Site Number : 2500005 — Le Plessis-Robinson, France
  • Investigational Site Number : 2500006 — Marseille, France
  • Investigational Site Number : 2500004 — Paris, France
  • Investigational Site Number : 2500002 — Pessac, France
  • Investigational Site Number : 2500003 — Saint-Herblain, France
  • Investigational Site Number : 2500007 — Strasbourg, France
  • Investigational Site Number : 2500001 — Suresnes, France
  • Investigational Site Number : 2760003 — Munich, Germany
  • Investigational Site Number : 3480001 — Budapest, Hungary
  • Investigational Site Number : 3760001 — Petah Tikva, Israel
  • Investigational Site Number : 3800001 — Milan, Milano, Italy
  • Investigational Site Number : 3800005 — Padua, Padova, Italy
  • Investigational Site Number : 3800004 — Palermo, Italy
  • Investigational Site Number : 3800003 — Pavia, Italy
  • Investigational Site Number : 3800002 — Siena, Italy
  • Investigational Site Number : 3920001 — Tokyo, Japan
  • Investigational Site Number : 5280001 — Groningen, Netherlands
  • Investigational Site Number : 4100004 — Yangsan, Gyeongsangnam-do, South Korea
  • Investigational Site Number : 4100002 — Seoul, Seoul-teukbyeolsi, South Korea
  • Investigational Site Number : 4100001 — Seoul, Seoul-teukbyeolsi, South Korea
  • Investigational Site Number : 4100003 — Seoul, Seoul-teukbyeolsi, South Korea
  • Investigational Site Number : 7240001 — Santander, Cantabria, Spain
  • Investigational Site Number : 7240003 — Barcelona, Catalunya [Cataluña], Spain
  • Investigational Site Number : 7240002 — A Coruña, Galicia [Galicia], Spain
  • Investigational Site Number : 7240005 — Majadahonda, Madrid, Spain
  • Investigational Site Number : 7240004 — Valencia, Spain
  • Investigational Site Number : 7520001 — Gothenburg, Sweden
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record