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RecruitingPhase 3

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

Sanofi · with Meiji Seika Pharma Co., Ltd. · NCT06082037

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
180
US sites recruiting
32
Study start
October 10, 2023
Record last updated
September 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Belumosudil; Azithromycin; Placebo

Conditions: Lung Transplant Rejection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • University of Alabama at Birmingham- Site Number : 8400026

    Birmingham, AL 35233

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

    Phoenix, AZ 85013

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

    Los Angeles, CA 90095

  • Stanford University Medical Center- Site Number : 8400008

    Stanford, CA 94305

  • Mayo Clinic in Florida- Site Number : 8400031

    Jacksonville, FL 32224

  • Jackson Memorial Hospital- Site Number : 8400030

    Miami, FL 33136

  • AdventHealth Orlando- Site Number : 8400023

    Orlando, FL 32803

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

    Tampa, FL 33606

  • Emory University Hospital- Site Number : 8400027

    Atlanta, GA 30324

  • Northwestern University- Site Number : 8400003

    Chicago, IL 60611

  • Loyola University Medical Center- Site Number : 8400025

    Maywood, IL 60153

  • University of Iowa- Site Number : 8400032

    Iowa City, IA 52242

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

    Baltimore, MD 21201

  • Johns Hopkins Hospital- Site Number : 8400034

    Baltimore, MD 21287

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

    Ann Arbor, MI 48109

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

    Grand Rapids, MI 49503

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

    New York, NY 10016

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

    New York, NY 10029

  • Columbia University Irving Medical Center- Site Number : 8400002

    New York, NY 10032

  • Montefiore Medical Center - Moses Campus- Site Number : 8400036

    The Bronx, NY 10467

  • Duke University Medical Center- Site Number : 8400017

    Durham, NC 27705

  • Cleveland Clinic - Cleveland- Site Number : 8400005

    Cleveland, OH 44195

  • The Ohio State University- Site Number : 8400028

    Columbus, OH 43210

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

    Philadelphia, PA 19104

  • Temple University Hospital- Site Number : 8400007

    Philadelphia, PA 19140

  • Vanderbilt University Medical Center- Site Number : 8400018

    Nashville, TN 37232

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

    Dallas, TX 75390

  • Baylor College of Medicine- Site Number : 8400024

    Houston, TX 77030

  • Houston Methodist Hospital- Site Number : 8400021

    Houston, TX 77030

  • University Health System - San Antonio- Site Number : 8400035

    San Antonio, TX 78229

  • University of Utah Medical Group- Site Number : 8400039

    Salt Lake City, UT 84102

  • Inova Fairfax Hospital- Site Number : 8400004

    Falls Church, VA 22042

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free number for US & Canada) · 800-633-1610 · contact-us@sanofi.com
A Study to Test How Effective Belumosudil Tablets Are for Treating… (NCT06082037) | Bored Studies