A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Launched by SANOFI · Oct 7, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called belumosudil to see how effective it is in treating adults who have chronic lung allograft dysfunction (CLAD) after receiving a lung transplant. The trial involves giving some participants belumosudil while others receive a placebo (a non-active treatment), alongside standard care and a medication called azithromycin. This study aims to find out if belumosudil can help improve lung function and overall health in people who are showing signs of worsening CLAD even while on azithromycin.
To participate, individuals must be at least 18 years old, have had a bilateral lung transplant for at least a year, and have been receiving azithromycin for at least eight weeks. Participants will visit the study site up to ten times over approximately 31 weeks, with some possibly extending their participation for up to 57 weeks. During this time, they will be monitored for their health and response to treatment. This trial is currently recruiting participants, and it’s important to note that those with certain other lung issues or recent treatments for CLAD may not qualify.
Gender
ALL
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
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Petah Tikva, , Israel
Leuven, , Belgium
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Helsinki, , Finland
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Copenhagen, , Denmark
München, , Germany
Pessac, , France
Petah Tikva, , Israel
Pavia, , Italy
Wien, , Austria
Budapest, , Hungary
Zhengzhou, , China
Santander, Cantabria, Spain
Milano, , Italy
Barcelona, Barcelona [Barcelona], Spain
Groningen, , Netherlands
Murdoch, Western Australia, Australia
La Coruña, A Coruña [La Coruña], Spain
Orlando, Florida, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Godinne, , Belgium
Siena, , Italy
Saint Herblain, , France
Olomouc, , Czechia
Valencia, , Spain
Ann Arbor, Michigan, United States
Palermo, , Italy
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
Birmingham, Alabama, United States
New York, New York, United States
Dallas, Texas, United States
Marseille, , France
Hangzhou, , China
Durham, North Carolina, United States
Praha 5, , Czechia
Budapest, , Hungary
Atlanta, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Darlinghurst, New South Wales, Australia
Chermside, Queensland, Australia
La Plessis Robinson, , France
Paris, , France
Oslo, , Norway
Phoenix, Arizona, United States
Los Angeles, California, United States
Stanford, California, United States
Miami, Florida, United States
Tampa, Florida, United States
Maywood, Illinois, United States
Bronx, New York, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Falls Church, Virginia, United States
Vancouver, British Columbia, Canada
Praha 5 Motol, , Czechia
Suresnes, , France
Palermo, , Italy
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Stanford, California, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Bronx, New York, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Falls Church, Virginia, United States
Sydney, New South Wales, Australia
Brisbane, Queensland, Australia
Murdoch, Western Australia, Australia
Vienna, , Austria
Yvoir, , Belgium
Guangzhou, , China
Wuxi, , China
Olomouc, , Czechia
Prague, , Czechia
Le Plessis Robinson, , France
Marseille, , France
Paris, , France
Pessac, , France
Saint Herblain, , France
Suresnes, , France
Munich, , Germany
Petah Tikva, , Israel
Milan, , Italy
Groningen, , Netherlands
Oslo, , Norway
A Coruña, A Coruña [La Coruña], Spain
Jacksonville, Florida, United States
Baltimore, Maryland, United States
New York, New York, United States
Toronto, Ontario, Canada
Chengdu, , China
Edmonton, Alberta, Canada
New York, New York, United States
San Antonio, Texas, United States
Milano, Lombardia, Italy
Pavia, Lombardia, Italy
Palermo, Sicilia, Italy
Siena, Toscana, Italy
Nashville, Tennessee, United States
Hefei, , China
Houston, Texas, United States
Beijing, , China
Nashville, Tennessee, United States
Dallas, Texas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Bronx, New York, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fuzhou, , China
Yangsan Si, Gyeongsangnam Do, Korea, Republic Of
Barcelona, , Spain
A Coruña, , Spain
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported