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A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Sponsor: Sanofi
Summary
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.
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study, Followed by Open-label Extensions, to Evaluate the Efficacy of Oral Belumosudil in Adult Participants With Chronic Lung Allograft Dysfunction (CLAD) Following Bilateral Lung Transplantation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2023-10-10
Completion Date
2030-10-01
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Belumosudil
Tablet, Oral
Azithromycin
Depends on pharmaceutical presentation, Oral
Placebo
Tablet, Oral
Locations (80)
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
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
Baylor University Medical Center- Site Number : 8400011
Dallas, Texas, 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
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 : 2500002
Pessac, France
Investigational Site Number : 2500003
Saint-Herblain, France
Investigational Site Number : 2500001
Suresnes, France
Investigational Site Number : 2760003
Munich, Germany
Investigational Site Number : 3480001
Budapest, Hungary
Investigational Site Number : 2500004
Mumbai, India
Investigational Site Number : 3760001
Petah Tikva, Israel
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano-Site Number : 3800001
Milan, Milano, Italy
Investigational Site Number : 3800005
Padua, Padova, Italy
IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)-Site Number : 3800004
Palermo, Italy
Fondazione IRCCS Policlinico San Matteo-Site Number : 3800003
Pavia, Italy
Azienda Ospedaliera Universitaria Senese UOC Malattie Respiratorie e Trapianto Polmonare-Site Number : 3800002
Siena, Italy
Brigham & Women's Hospital- Site Number : 8400016
Joso-Shi, Massachusetts, Japan
Investigational Site Number : 5280001
Groningen, Netherlands
Investigational Site Number : 5780001
Oslo, Norway
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 : 7240002
A Coruña, A Coruña [La Coruña], Spain
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001
Santander, Cantabria, Spain
Investigational Site Number : 7240004
Valencia, Spain
Investigational Site Number : 7520001
Gothenburg, Sweden