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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Belumosudil + Azithromycin 		Participants will receive 200 mg belumosudil orally once daily
  • Drug: Belumosudil
    Tablet, Oral
    Other names:
    • REZUROCK
  • Drug: Azithromycin
    Depends on pharmaceutical presentation, Oral
Placebo Comparator
Placebo + Azithromycin 		Participants will receive placebo orally once daily
  • Drug: Azithromycin
    Depends on pharmaceutical presentation, Oral
  • Drug: Placebo
    Tablet, Oral

Recruiting Locations

University of Alabama at Birmingham- Site Number : 8400026
Birmingham, Alabama 35233

St. Joseph's Hospital and Medical Center- Site Number : 8400019
Phoenix, Arizona 85013

University of California Los Angeles Medical Center- Site Number : 8400020
Los Angeles, California 90095

Stanford University Medical Center- Site Number : 8400008
Stanford, California 94305

Mayo Clinic in Florida- Site Number : 8400031
Jacksonville, Florida 32224

Jackson Memorial Hospital- Site Number : 8400030
Miami, Florida 33136

AdventHealth Orlando- Site Number : 8400023
Orlando, Florida 32803

Tampa General Hospital - Tampa - General Circle- Site Number : 8400015
Tampa, Florida 33606

Emory University Hospital- Site Number : 8400027
Atlanta, Georgia 30324

Northwestern University- Site Number : 8400003
Chicago, Illinois 60611

Loyola University Medical Center- Site Number : 8400025
Maywood, Illinois 60153

University of Iowa- Site Number : 8400032
Iowa City, Iowa 52242

University of Maryland School of Medicine - Baltimore- Site Number : 8400009
Baltimore, Maryland 21201

Johns Hopkins Hospital- Site Number : 8400034
Baltimore, Maryland 21287

Brigham & Women's Hospital- Site Number : 8400016
Boston, Massachusetts 02115

University of Michigan Health System - Ann Arbor- Site Number : 8400014
Ann Arbor, Michigan 48109

Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400010
Grand Rapids, Michigan 49503

NYU Perlmutter Cancer Center - Energy Building- Site Number : 8400001
New York, New York 10016

Icahn School of Medicine at Mount Sinai- Site Number : 8400037
New York, New York 10029

Columbia University Irving Medical Center- Site Number : 8400002
New York, New York 10032

Montefiore Medical Center - Moses Campus- Site Number : 8400036
The Bronx, New York 10467

Duke University Medical Center- Site Number : 8400017
Durham, North Carolina 27710

Cleveland Clinic - Cleveland- Site Number : 8400005
Cleveland, Ohio 44195

The Ohio State University- Site Number : 8400028
Columbus, Ohio 43210

Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006
Philadelphia, Pennsylvania 19104

Temple University Hospital- Site Number : 8400007
Philadelphia, Pennsylvania 19140

Vanderbilt University Medical Center- Site Number : 8400018
Nashville, Tennessee 37232

University of Texas - Southwestern Medical Center- Site Number : 8400013
Dallas, Texas 75390

Baylor College of Medicine- Site Number : 8400024
Houston, Texas 77030

Houston Methodist Hospital- Site Number : 8400021
Houston, Texas 77030

University Health System - San Antonio- Site Number : 8400035
San Antonio, Texas 78229

Inova Fairfax Hospital- Site Number : 8400004
Falls Church, Virginia 22042

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610
contact-us@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.