Recruiting

Phase 3

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

Sponsor:

Sanofi

Code:

NCT06082037

Conditions

Lung Transplant Rejection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Belumosudil

Azithromycin

Placebo

Study Details

Brief 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.

Conditions

Lung Transplant Rejection

Study ID

NCT06082037

Start date

Oct 10, 2023

Status verified date

Sep, 2026

Completion date

Oct 1, 2030

Anticipated

Primary completion date

Jan 29, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Belumosudil + Azithromycin

Participants will receive 200 mg belumosudil orally once daily

placebo comparator: Placebo + Azithromycin

Participants will receive placebo orally once daily

Interventions

Belumosudil

Tablet, Oral

Azithromycin

Depends on pharmaceutical presentation, Oral

Placebo

Tablet, Oral

Primary outcome measure

Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to Week 26 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free number for US & Canada)

800-633-1610 contact-us@sanofi.com

Locations

University of Alabama at Birmingham- Site Number : 8400026

Recruiting

Birmingham, Alabama, United States, 35233

St. Joseph's Hospital and Medical Center- Site Number : 8400019

Recruiting

Phoenix, Arizona, United States, 85013

University of California Los Angeles Medical Center- Site Number : 8400020

Recruiting

Los Angeles, California, United States, 90095

Stanford University Medical Center- Site Number : 8400008

Recruiting

Stanford, California, United States, 94305

Mayo Clinic in Florida- Site Number : 8400031

Recruiting

Jacksonville, Florida, United States, 32224

Jackson Memorial Hospital- Site Number : 8400030

Recruiting

Miami, Florida, United States, 33136

AdventHealth Orlando- Site Number : 8400023

Recruiting

Orlando, Florida, United States, 32803

Tampa General Hospital - Tampa - General Circle- Site Number : 8400015

Recruiting

Tampa, Florida, United States, 33606

Emory University Hospital- Site Number : 8400027

Recruiting

Atlanta, Georgia, United States, 30324

Northwestern University- Site Number : 8400003

Recruiting

Chicago, Illinois, United States, 60611

Loyola University Medical Center- Site Number : 8400025

Recruiting

Maywood, Illinois, United States, 60153

University of Iowa- Site Number : 8400032

Recruiting

Iowa City, Iowa, United States, 52242

University of Maryland School of Medicine - Baltimore- Site Number : 8400009

Recruiting

Baltimore, Maryland, United States, 21201

Johns Hopkins Hospital- Site Number : 8400034

Recruiting

Baltimore, Maryland, United States, 21287

University of Michigan Health System - Ann Arbor- Site Number : 8400014

Recruiting

Ann Arbor, Michigan, United States, 48109

Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400010

Recruiting

Grand Rapids, Michigan, United States, 49503

NYU Perlmutter Cancer Center - Energy Building- Site Number : 8400001

Recruiting

New York, New York, United States, 10016

Icahn School of Medicine at Mount Sinai- Site Number : 8400037

Recruiting

New York, New York, United States, 10029

Columbia University Irving Medical Center- Site Number : 8400002

Recruiting

New York, New York, United States, 10032

Montefiore Medical Center - Moses Campus- Site Number : 8400036

Recruiting

The Bronx, New York, United States, 10467

Duke University Medical Center- Site Number : 8400017

Recruiting

Durham, North Carolina, United States, 27705

Cleveland Clinic - Cleveland- Site Number : 8400005

Recruiting

Cleveland, Ohio, United States, 44195

The Ohio State University- Site Number : 8400028

Recruiting

Columbus, Ohio, United States, 43210

Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Temple University Hospital- Site Number : 8400007

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Vanderbilt University Medical Center- Site Number : 8400018

Recruiting

Nashville, Tennessee, United States, 37232

University of Texas - Southwestern Medical Center- Site Number : 8400013

Recruiting

Dallas, Texas, United States, 75390

Baylor College of Medicine- Site Number : 8400024

Recruiting

Houston, Texas, United States, 77030

Houston Methodist Hospital- Site Number : 8400021

Recruiting

Houston, Texas, United States, 77030

University Health System - San Antonio- Site Number : 8400035

Recruiting

San Antonio, Texas, United States, 78229

University of Utah Medical Group- Site Number : 8400039

Recruiting

Salt Lake City, Utah, United States, 84102

Inova Fairfax Hospital- Site Number : 8400004

Recruiting

Falls Church, Virginia, United States, 22042

Investigational Site Number : 1240002

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Investigational Site Number : 1240001

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Investigational Site Number : 1240004

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

Sanofi

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Sanofi on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.