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New hope for lung transplant patients: drug may slow chronic rejection

NCT ID NCT06082037

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 30, 2026 · Updated 4 times

Summary

This Phase 3 trial tests an oral drug called belumosudil in adults who have chronic lung allograft dysfunction (CLAD) after a bilateral lung transplant. CLAD is a form of chronic rejection that slowly worsens lung function. The study compares belumosudil to a placebo, both given alongside standard care including azithromycin. About 180 participants will be followed for up to 57 weeks to see if the drug can slow the decline in lung function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Belumosudil (also known as REZUROCK)
What this could lead to
If it works, this could provide a new treatment option to slow lung function decline in lung transplant patients with CLAD.
What could go wrong
This is a Phase 3 trial, but belumosudil is tested on top of standard care. It may not show significant benefit over placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

bronchiolitis obliterans syndrome transplant rejection transplant-related bronchiolitis obliterans

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung transplant rejection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    79 sites in 19 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AdventHealth Orlando- Site Number : 8400023

    RECRUITING

    Orlando, Florida, 32803, United States

  • Azienda Ospedaliera Universitaria Senese UOC Malattie Respiratorie e Trapianto Polmonare-Site Number : 3800002

    RECRUITING

    Siena, 53100, Italy

  • Baylor College of Medicine- Site Number : 8400024

    RECRUITING

    Houston, Texas, 77030, United States

  • Brigham & Women's Hospital- Site Number : 8400016

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic - Cleveland- Site Number : 8400005

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center- Site Number : 8400002

    RECRUITING

    New York, New York, 10032, United States

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

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Duke University Medical Center- Site Number : 8400017

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University Hospital- Site Number : 8400027

    RECRUITING

    Atlanta, Georgia, 30324, United States

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano-Site Number : 3800001

    RECRUITING

    Milan, Milano, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo-Site Number : 3800003

    RECRUITING

    Pavia, 27100, Italy

  • Houston Methodist Hospital- Site Number : 8400021

    RECRUITING

    Houston, Texas, 77030, United States

  • IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)-Site Number : 3800004

    RECRUITING

    Palermo, 90133, Italy

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

    RECRUITING

    New York, New York, 10029, United States

  • Inova Fairfax Hospital- Site Number : 8400004

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Investigational Site Number : 0360001

    RECRUITING

    Brisbane, Queensland, 4032, Australia

  • Investigational Site Number : 0360002

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Investigational Site Number : 0360003

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Investigational Site Number : 0400001

    RECRUITING

    Vienna, 1090, Austria

  • Investigational Site Number : 0560001

    RECRUITING

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    RECRUITING

    Yvoir, 5530, Belgium

  • Investigational Site Number : 1240001

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Investigational Site Number : 1240002

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • Investigational Site Number : 1240004

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Investigational Site Number : 1560001

    RECRUITING

    Hangzhou, 310009, China

  • Investigational Site Number : 1560002

    RECRUITING

    Chengdu, 610072, China

  • Investigational Site Number : 1560003

    RECRUITING

    Wuxi, 214023, China

  • Investigational Site Number : 1560004

    RECRUITING

    Beijing, 100029, China

  • Investigational Site Number : 1560005

    RECRUITING

    Hefei, 230001, China

  • Investigational Site Number : 1560006

    RECRUITING

    Zhengzhou, 450052, China

  • Investigational Site Number : 1560007

    RECRUITING

    Guangzhou, 510163, China

  • Investigational Site Number : 1560008

    RECRUITING

    Fuzhou, 350001, China

  • Investigational Site Number : 1560009

    RECRUITING

    Shanghai, 200433, China

  • Investigational Site Number : 2030001

    RECRUITING

    Prague, 150 06, Czechia

  • Investigational Site Number : 2030002

    RECRUITING

    Olomouc, 779 00, Czechia

  • Investigational Site Number : 2080001

    RECRUITING

    Copenhagen, 2100, Denmark

  • Investigational Site Number : 2460001

    RECRUITING

    Helsinki, 00029, Finland

  • Investigational Site Number : 2500001

    RECRUITING

    Suresnes, 92151, France

  • Investigational Site Number : 2500002

    RECRUITING

    Pessac, 33604, France

  • Investigational Site Number : 2500003

    RECRUITING

    Saint-Herblain, 44800, France

  • Investigational Site Number : 2500004

    RECRUITING

    Paris, 75018, France

  • Investigational Site Number : 2500005

    RECRUITING

    Le Plessis-Robinson, 92350, France

  • Investigational Site Number : 2500006

    RECRUITING

    Marseille, 13915, France

  • Investigational Site Number : 2760003

    RECRUITING

    Munich, 81337, Germany

  • Investigational Site Number : 3480001

    RECRUITING

    Budapest, 1085, Hungary

  • Investigational Site Number : 3760001

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Investigational Site Number : 3800005

    RECRUITING

    Padua, Padova, 35128, Italy

  • Investigational Site Number : 3920001

    RECRUITING

    Tokyo, 113-8654, Japan

  • Investigational Site Number : 4100001

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100002

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100003

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100004

    RECRUITING

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Investigational Site Number : 5280001

    RECRUITING

    Groningen, 9713 GR, Netherlands

  • Investigational Site Number : 7240001

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    A Coruña, A Coruña [La Coruña], 15006, Spain

  • Investigational Site Number : 7240003

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240004

    RECRUITING

    Valencia, 46026, Spain

  • Investigational Site Number : 7520001

    RECRUITING

    Gothenburg, 413 45, Sweden

  • Jackson Memorial Hospital- Site Number : 8400030

    RECRUITING

    Miami, Florida, 33136, United States

  • Johns Hopkins Hospital- Site Number : 8400034

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Loyola University Medical Center- Site Number : 8400025

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Mayo Clinic in Florida- Site Number : 8400031

    RECRUITING

    Jacksonville, Florida, 32224, United States

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

    RECRUITING

    The Bronx, New York, 10467, United States

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

    RECRUITING

    New York, New York, 10016, United States

  • Northwestern University- Site Number : 8400003

    RECRUITING

    Chicago, Illinois, 60611, United States

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

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Stanford University Medical Center- Site Number : 8400008

    RECRUITING

    Stanford, California, 94305, United States

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

    RECRUITING

    Tampa, Florida, 33606, United States

  • Temple University Hospital- Site Number : 8400007

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Ohio State University- Site Number : 8400028

    RECRUITING

    Columbus, Ohio, 43210, United States

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

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Alabama at Birmingham- Site Number : 8400026

    RECRUITING

    Birmingham, Alabama, 35233, United States

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

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Iowa- Site Number : 8400032

    RECRUITING

    Iowa City, Iowa, 52242, United States

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

    RECRUITING

    Baltimore, Maryland, 21201, United States

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

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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

    RECRUITING

    Dallas, Texas, 75390, United States

  • Vanderbilt University Medical Center- Site Number : 8400018

    RECRUITING

    Nashville, Tennessee, 37232, United States

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