A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
NCT ID: NCT06082037
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2023-10-10
2028-06-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Belumosudil + Azithromycin
Participants will receive 200 mg belumosudil orally once daily
Belumosudil
Tablet, Oral
Azithromycin
Depends on pharmaceutical presentation, Oral
Placebo + Azithromycin
Participants will receive placebo orally once daily
Azithromycin
Depends on pharmaceutical presentation, Oral
Placebo
Tablet, Oral
Interventions
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Belumosudil
Tablet, Oral
Azithromycin
Depends on pharmaceutical presentation, Oral
Placebo
Tablet, Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Meiji Seika Pharma Co., Ltd.
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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UAB Lung Health Center- Site Number : 8400026
Birmingham, Alabama, United States
St. Joseph's Hospital & Medical Center - Norton Thoracic Research Department- Site Number : 8400019
Phoenix, Arizona, United States
David Geffen School of Medicine at UCLA- Site Number : 8400020
Los Angeles, California, United States
Stanford Health Care - Center for Advance Lung Disease- Site Number : 8400008
Stanford, California, United States
Mayo Clinic- Site Number : 8400031
Jacksonville, Florida, United States
University of Miami - Jackson Memorial Hospital- Site Number : 8400030
Miami, Florida, United States
Advent Health Transplant Institute- Site Number : 8400023
Orlando, Florida, United States
Tampa General Hospital- 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 Hospitals And Clinics- Site Number : 8400032
Iowa City, Iowa, United States
University of Maryland School of Medicine- Site Number : 8400009
Baltimore, Maryland, United States
~Johns Hopkins University School of Medicine- Site Number : 8400034
Baltimore, Maryland, United States
Brigham & Women's Hospital/VA Boston Lung Transplant Program- Site Number : 8400016
Boston, Massachusetts, United States
University of Michigan Hospital - 1500 E Medical Center Dr- Site Number : 8400014
Ann Arbor, Michigan, United States
Corewell Health- Site Number : 8400010
Grand Rapids, Michigan, United States
NYU Langone Medical Center- 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
New York Presbyterian/Columbia University Medical Center- Site Number : 8400002
New York, New York, United States
Montefiore Medical Center- Site Number : 8400036
The Bronx, New York, United States
Duke Lung Transplant Program- Site Number : 8400017
Durham, North Carolina, United States
Cleveland Clinic Foundation- Site Number : 8400005
Cleveland, Ohio, United States
OSU Wexner Medical Center- Site Number : 8400028
Columbus, Ohio, United States
University of Pennsylvania - Harron Lung Center- 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 - Dallas- Site Number : 8400011
Dallas, Texas, United States
UT Southwestern Medical Center- Site Number : 8400013
Dallas, Texas, United States
Baylor University Medical Center - Houston- Site Number : 8400024
Houston, Texas, United States
Houston Methodist Research Institute- Site Number : 8400021
Houston, Texas, United States
UT Health San Antonio - University Hospital- Site Number : 8400035
San Antonio, Texas, United States
Inova Fairfax Medical Campus - IHVI ALD and Lung Transplant Services- Site Number : 8400004
Falls Church, Virginia, United States
Investigational Site Number : 0360003
Darlinghurst, New South Wales, Australia
Investigational Site Number : 0360001
Chermside, Queensland, Australia
Investigational Site Number : 0360002
Murdoch, Western Australia, Australia
Investigational Site Number : 0400001
Vienna, , Austria
Investigational Site Number : 0560002
Godinne, , Belgium
Investigational Site Number : 0560001
Leuven, , 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
Praha 5 - Motol, , Czechia
Investigational Site Number : 2080001
Copenhagen, , Denmark
Investigational Site Number : 2460001
Helsinki, , Finland
Investigational Site Number : 2500005
La 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 : 2500001
Suresnes, , France
Investigational Site Number : 2760003
München, , Germany
Investigational Site Number : 3480001
Budapest, , Hungary
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, , 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
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
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free number for US & Canada)
Role: CONTACT
Facility Contacts
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Related Links
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EFC17801 Plain Language Results Summary
Other Identifiers
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U1111-1280-6777
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-503462-23
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC17801
Identifier Type: -
Identifier Source: org_study_id
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