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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06082037

Public ClinicalTrials.gov record NCT06082037. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 12:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06082037
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
180 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 9, 2023
Primary completion
Jan 28, 2029
Completion
Sep 30, 2030
Last update posted
Jun 28, 2026

2023 – 2030

United States locations

U.S. sites
32
U.S. states
17
U.S. cities
27
Facility City State ZIP Site status
University of Alabama at Birmingham- Site Number : 8400026 Birmingham Alabama 35233 Recruiting
St. Joseph's Hospital and Medical Center- Site Number : 8400019 Phoenix Arizona 85013 Recruiting
University of California Los Angeles Medical Center- Site Number : 8400020 Los Angeles California 90095 Recruiting
Stanford University Medical Center- Site Number : 8400008 Stanford California 94305 Recruiting
Mayo Clinic in Florida- Site Number : 8400031 Jacksonville Florida 32224 Recruiting
Jackson Memorial Hospital- Site Number : 8400030 Miami Florida 33136 Recruiting
AdventHealth Orlando- Site Number : 8400023 Orlando Florida 32803 Recruiting
Tampa General Hospital - Tampa - General Circle- Site Number : 8400015 Tampa Florida 33606 Recruiting
Emory University Hospital- Site Number : 8400027 Atlanta Georgia 30324 Recruiting
Northwestern University- Site Number : 8400003 Chicago Illinois 60611 Recruiting
Loyola University Medical Center- Site Number : 8400025 Maywood Illinois 60153 Recruiting
University of Iowa- Site Number : 8400032 Iowa City Iowa 52242 Recruiting
University of Maryland School of Medicine - Baltimore- Site Number : 8400009 Baltimore Maryland 21201 Recruiting
Johns Hopkins Hospital- Site Number : 8400034 Baltimore Maryland 21287 Recruiting
Brigham & Women's Hospital- Site Number : 8400016 Boston Massachusetts 02115 Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400014 Ann Arbor Michigan 48109 Recruiting
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400010 Grand Rapids Michigan 49503 Recruiting
NYU Perlmutter Cancer Center - Energy Building- Site Number : 8400001 New York New York 10016 Recruiting
Icahn School of Medicine at Mount Sinai- Site Number : 8400037 New York New York 10029 Recruiting
Columbia University Irving Medical Center- Site Number : 8400002 New York New York 10032 Recruiting
Montefiore Medical Center - Moses Campus- Site Number : 8400036 The Bronx New York 10467 Recruiting
Duke University Medical Center- Site Number : 8400017 Durham North Carolina 27710 Recruiting
Cleveland Clinic - Cleveland- Site Number : 8400005 Cleveland Ohio 44195 Recruiting
The Ohio State University- Site Number : 8400028 Columbus Ohio 43210 Recruiting
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006 Philadelphia Pennsylvania 19104 Recruiting
Temple University Hospital- Site Number : 8400007 Philadelphia Pennsylvania 19140 Recruiting
Vanderbilt University Medical Center- Site Number : 8400018 Nashville Tennessee 37232 Recruiting
University of Texas - Southwestern Medical Center- Site Number : 8400013 Dallas Texas 75390 Recruiting
Baylor College of Medicine- Site Number : 8400024 Houston Texas 77030 Recruiting
Houston Methodist Hospital- Site Number : 8400021 Houston Texas 77030 Recruiting
University Health System - San Antonio- Site Number : 8400035 San Antonio Texas 78229 Recruiting
Inova Fairfax Hospital- Site Number : 8400004 Falls Church Virginia 22042 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06082037, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 28, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06082037 live on ClinicalTrials.gov.

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