Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Oral Belumosudil in Adults With Chronic Lung Allograft Dysfunction After Bilateral Lung Transplant, Followed by Open-label Extensions
Led by Sanofi · Updated on 2026-06-02
180
Participants Needed
80
Research Sites
87 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
M
Meiji Seika Pharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of belumosudil compared with placebo in adults with chronic lung allograft dysfunction (CLAD) who are at least one year after a bilateral lung transplant. This phase 3, double-blind, randomized, placebo-controlled study includes participants of both genders aged 18 years and older who continue to have worsening CLAD despite azithromycin therapy. The study is conducted across multiple countries and centers to gather comprehensive data on treatment outcomes. Participants will be randomly assigned to receive either 200 mg of belumosudil orally once daily or a placebo, both alongside azithromycin and the standard immunosuppression regimen. The treatment period lasts up to 26 weeks for those not entering the open-label extension (OLE) and up to 52 weeks for those who do. Participants entering the long-term OLE will continue treatment and study visits every 12 weeks according to protocol. Participants will attend up to 10 visits during the initial phase or up to 16 visits if they enter the OLE. Assessments include lung function tests such as forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), 6-minute walk distance, and quality of life questionnaires like the Saint George Respiratory Questionnaire (SGRQ). Researchers will monitor changes in these measures, track adverse events, and evaluate the time to CLAD progression, re-transplantation, or death. Study participation may continue for several months with ongoing safety monitoring.
CONDITIONS
Brief Title
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is at least 1 year post bilateral lung transplant at screening
- Participants have CLAD Stage 1 or 2 with FEV1 from greater than 50% to 80% of post-transplant baseline at screening and randomization
- Participants have received at least 8 weeks of azithromycin (250 mg/day or more, at least 3 times a week) before randomization
- Adults aged 18 years or older
You will not qualify if you...
- FEV1 is 50% or less of post-transplant baseline value (CLAD Stage 3 or 4)
- Lung function decline caused by non-CLAD reasons such as acute lung rejection (greater than A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive oral tablets of belumosudil or placebo daily along with azithromycin to treat chronic lung allograft dysfunction.
Regular visits during the 26-week treatment period
Duration - Up to 7 days after treatment ends
Participants are monitored for safety and outcomes up to 7 days after the last dose of study drug.
1 follow-up visit
Trial Site Locations
Total: 80 locations
1
University of Alabama at Birmingham- Site Number : 8400026
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
St. Joseph's Hospital and Medical Center- Site Number : 8400019
Phoenix, Arizona, United States, 85013
Actively Recruiting
3
University of California Los Angeles Medical Center- Site Number : 8400020
Los Angeles, California, United States, 90095
Actively Recruiting
4
Stanford University Medical Center- Site Number : 8400008
Stanford, California, United States, 94305
Actively Recruiting
5
Mayo Clinic in Florida- Site Number : 8400031
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Jackson Memorial Hospital- Site Number : 8400030
Miami, Florida, United States, 33136
Actively Recruiting
7
AdventHealth Orlando- Site Number : 8400023
Orlando, Florida, United States, 32803
Actively Recruiting
8
Tampa General Hospital - Tampa - General Circle- Site Number : 8400015
Tampa, Florida, United States, 33606
Actively Recruiting
9
Emory University Hospital- Site Number : 8400027
Atlanta, Georgia, United States, 30324
Actively Recruiting
10
Northwestern University- Site Number : 8400003
Chicago, Illinois, United States, 60611
Actively Recruiting
11
Loyola University Medical Center- Site Number : 8400025
Maywood, Illinois, United States, 60153
Actively Recruiting
12
University of Iowa- Site Number : 8400032
Iowa City, Iowa, United States, 52242
Actively Recruiting
13
University of Maryland School of Medicine - Baltimore- Site Number : 8400009
Baltimore, Maryland, United States, 21201
Actively Recruiting
14
Johns Hopkins Hospital- Site Number : 8400034
Baltimore, Maryland, United States, 21287
Actively Recruiting
15
Brigham & Women's Hospital- Site Number : 8400016
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
University of Michigan Health System - Ann Arbor- Site Number : 8400014
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
17
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400010
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
18
NYU Perlmutter Cancer Center - Energy Building- Site Number : 8400001
New York, New York, United States, 10016
Actively Recruiting
19
Icahn School of Medicine at Mount Sinai- Site Number : 8400037
New York, New York, United States, 10029
Actively Recruiting
20
Columbia University Irving Medical Center- Site Number : 8400002
New York, New York, United States, 10032
Actively Recruiting
21
Montefiore Medical Center - Moses Campus- Site Number : 8400036
The Bronx, New York, United States, 10467
Actively Recruiting
22
Duke University Medical Center- Site Number : 8400017
Durham, North Carolina, United States, 27710
Actively Recruiting
23
Cleveland Clinic - Cleveland- Site Number : 8400005
Cleveland, Ohio, United States, 44195
Actively Recruiting
24
The Ohio State University- Site Number : 8400028
Columbus, Ohio, United States, 43210
Actively Recruiting
25
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
26
Temple University Hospital- Site Number : 8400007
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
27
Vanderbilt University Medical Center- Site Number : 8400018
Nashville, Tennessee, United States, 37232
Actively Recruiting
28
University of Texas - Southwestern Medical Center- Site Number : 8400013
Dallas, Texas, United States, 75390
Actively Recruiting
29
Baylor College of Medicine- Site Number : 8400024
Houston, Texas, United States, 77030
Actively Recruiting
30
Houston Methodist Hospital- Site Number : 8400021
Houston, Texas, United States, 77030
Actively Recruiting
31
University Health System - San Antonio- Site Number : 8400035
San Antonio, Texas, United States, 78229
Actively Recruiting
32
Inova Fairfax Hospital- Site Number : 8400004
Falls Church, Virginia, United States, 22042
Actively Recruiting
33
Investigational Site Number : 0360003
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
34
Investigational Site Number : 0360001
Brisbane, Queensland, Australia, 4032
Actively Recruiting
35
Investigational Site Number : 0360002
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
36
Investigational Site Number : 0400001
Vienna, Austria, 1090
Actively Recruiting
37
Investigational Site Number : 0560001
Leuven, Belgium, 3000
Actively Recruiting
38
Investigational Site Number : 0560002
Yvoir, Belgium, 5530
Actively Recruiting
39
Investigational Site Number : 1240002
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
40
Investigational Site Number : 1240001
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
41
Investigational Site Number : 1240004
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
42
Investigational Site Number : 1560004
Beijing, China, 100029
Actively Recruiting
43
Investigational Site Number : 1560002
Chengdu, China, 610072
Actively Recruiting
44
Investigational Site Number : 1560008
Fuzhou, China, 350001
Actively Recruiting
45
Investigational Site Number : 1560007
Guangzhou, China, 510163
Actively Recruiting
46
Investigational Site Number : 1560001
Hangzhou, China, 310009
Actively Recruiting
47
Investigational Site Number : 1560005
Hefei, China, 230001
Actively Recruiting
48
Investigational Site Number : 1560009
Shanghai, China, 200433
Actively Recruiting
49
Investigational Site Number : 1560003
Wuxi, China, 214023
Actively Recruiting
50
Investigational Site Number : 1560006
Zhengzhou, China, 450052
Actively Recruiting
51
Investigational Site Number : 2030002
Olomouc, Czechia, 779 00
Actively Recruiting
52
Investigational Site Number : 2030001
Prague, Czechia, 150 06
Actively Recruiting
53
Investigational Site Number : 2080001
Copenhagen, Denmark, 2100
Actively Recruiting
54
Investigational Site Number : 2460001
Helsinki, Finland, 00029
Actively Recruiting
55
Investigational Site Number : 2500005
Le Plessis-Robinson, France, 92350
Actively Recruiting
56
Investigational Site Number : 2500006
Marseille, France, 13915
Actively Recruiting
57
Investigational Site Number : 2500004
Paris, France, 75018
Actively Recruiting
58
Investigational Site Number : 2500002
Pessac, France, 33604
Actively Recruiting
59
Investigational Site Number : 2500003
Saint-Herblain, France, 44800
Actively Recruiting
60
Investigational Site Number : 2500001
Suresnes, France, 92151
Actively Recruiting
61
Investigational Site Number : 2760003
Munich, Germany, 81337
Actively Recruiting
62
Investigational Site Number : 3480001
Budapest, Hungary, 1085
Actively Recruiting
63
Investigational Site Number : 3760001
Petah Tikva, Israel, 4941492
Actively Recruiting
64
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano-Site Number : 3800001
Milan, Milano, Italy, 20122
Actively Recruiting
65
Investigational Site Number : 3800005
Padua, Padova, Italy, 35128
Actively Recruiting
66
IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)-Site Number : 3800004
Palermo, Italy, 90133
Actively Recruiting
67
Fondazione IRCCS Policlinico San Matteo-Site Number : 3800003
Pavia, Italy, 27100
Actively Recruiting
68
Azienda Ospedaliera Universitaria Senese UOC Malattie Respiratorie e Trapianto Polmonare-Site Number : 3800002
Siena, Italy, 53100
Actively Recruiting
69
Investigational Site Number : 3920001
Tokyo, Japan, 113-8654
Actively Recruiting
70
Investigational Site Number : 5280001
Groningen, Netherlands, 9713 GR
Actively Recruiting
71
Investigational Site Number : 5780001
Oslo, Norway, 0372
Actively Recruiting
72
Investigational Site Number : 4100004
Yangsan, Gyeongsangnam-do, South Korea, 50612
Actively Recruiting
73
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea, 03080
Actively Recruiting
74
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Actively Recruiting
75
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea, 06351
Actively Recruiting
76
Investigational Site Number : 7240002
A Coruña, A Coruña [La Coruña], Spain, 15006
Actively Recruiting
77
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
78
Investigational Site Number : 7240001
Santander, Cantabria, Spain, 39008
Actively Recruiting
79
Investigational Site Number : 7240004
Valencia, Spain, 46026
Actively Recruiting
80
Investigational Site Number : 7520001
Gothenburg, Sweden, 413 45
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free number for US & Canada)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here