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

NCT06082037 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: EFC17801U1111-1280-67772023-503462-23
• Study Type: interventional
• Target: 180
• Locations: 20 countries
• Sites: 78

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

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)

  Baseline to Week 26

Secondary Outcomes (14)

• Response rate at Week 26

  Baseline to Week 26

• Absolute change from baseline to Week 26 in FEV1

  Baseline to Week 26

• Absolute change from baseline to Week 26 in percent predicted FEV1

  Baseline to Week 26

• Percent change from baseline to Week 26 in forced vital capacity (FVC)

  Baseline to Week 26

• Absolute change from baseline to Week 26 in FVC

  Baseline to Week 26

Study Arms (2)

Belumosudil + Azithromycin

EXPERIMENTAL

Participants will receive 200 mg belumosudil orally once daily

Drug: Belumosudil; Drug: Azithromycin

Placebo + Azithromycin

PLACEBO COMPARATOR

Participants will receive placebo orally once daily

Drug: Azithromycin; Drug: Placebo

Interventions

Azithromycin DRUG

Depends on pharmaceutical presentation, Oral

Belumosudil + Azithromycin; Placebo + Azithromycin

Placebo DRUG

Tablet, Oral

Placebo + Azithromycin

Belumosudil DRUG

Tablet, Oral

Also known as: REZUROCK

Belumosudil + Azithromycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Meiji Seika Pharma Co., Ltd.: collaborator

Study Sites (79)

University of Alabama at Birmingham- Site Number : 8400026

Birmingham, Alabama, 35233, United States

RECRUITING

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

Phoenix, Arizona, 85013, United States

RECRUITING

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

Los Angeles, California, 90095, United States

RECRUITING

Stanford University Medical Center- Site Number : 8400008

Stanford, California, 94305, United States

RECRUITING

Mayo Clinic in Florida- Site Number : 8400031

Jacksonville, Florida, 32224, United States

RECRUITING

Jackson Memorial Hospital- Site Number : 8400030

Miami, Florida, 33136, United States

RECRUITING

AdventHealth Orlando- Site Number : 8400023

Orlando, Florida, 32803, United States

RECRUITING

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

Tampa, Florida, 33606, United States

RECRUITING

Emory University Hospital- Site Number : 8400027

Atlanta, Georgia, 30324, United States

RECRUITING

Northwestern University- Site Number : 8400003

Chicago, Illinois, 60611, United States

RECRUITING

Loyola University Medical Center- Site Number : 8400025

Maywood, Illinois, 60153, United States

RECRUITING

University of Iowa- Site Number : 8400032

Iowa City, Iowa, 52242, United States

RECRUITING

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

Baltimore, Maryland, 21201, United States

RECRUITING

Johns Hopkins Hospital- Site Number : 8400034

Baltimore, Maryland, 21287, United States

RECRUITING

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

Ann Arbor, Michigan, 48109, United States

RECRUITING

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

Grand Rapids, Michigan, 49503, United States

RECRUITING

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

New York, New York, 10016, United States

RECRUITING

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

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical Center- Site Number : 8400002

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center - Moses Campus- Site Number : 8400036

The Bronx, New York, 10467, United States

RECRUITING

Duke University Medical Center- Site Number : 8400017

Durham, North Carolina, 27710, United States

RECRUITING

Cleveland Clinic - Cleveland- Site Number : 8400005

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University- Site Number : 8400028

Columbus, Ohio, 43210, United States

RECRUITING

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

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Temple University Hospital- Site Number : 8400007

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Vanderbilt University Medical Center- Site Number : 8400018

Nashville, Tennessee, 37232, United States

RECRUITING

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

Dallas, Texas, 75390, United States

RECRUITING

Baylor College of Medicine- Site Number : 8400024

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Hospital- Site Number : 8400021

Houston, Texas, 77030, United States

RECRUITING

University Health System - San Antonio- Site Number : 8400035

San Antonio, Texas, 78229, United States

RECRUITING

Inova Fairfax Hospital- Site Number : 8400004

Falls Church, Virginia, 22042, United States

RECRUITING

Investigational Site Number : 0360003

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Investigational Site Number : 0360001

Brisbane, Queensland, 4032, Australia

RECRUITING

Investigational Site Number : 0360002

Murdoch, Western Australia, 6150, Australia

RECRUITING

Investigational Site Number : 0400001

Vienna, 1090, Austria

RECRUITING

Investigational Site Number : 0560001

Leuven, 3000, Belgium

RECRUITING

Investigational Site Number : 0560002

Yvoir, 5530, Belgium

RECRUITING

Investigational Site Number : 1240002

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Investigational Site Number : 1240001

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Investigational Site Number : 1240004

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Investigational Site Number : 1560004

Beijing, 100029, China

RECRUITING

Investigational Site Number : 1560002

Chengdu, 610072, China

RECRUITING

Investigational Site Number : 1560008

Fuzhou, 350001, China

RECRUITING

Investigational Site Number : 1560007

Guangzhou, 510163, China

RECRUITING

Investigational Site Number : 1560001

Hangzhou, 310009, China

RECRUITING

Investigational Site Number : 1560005

Hefei, 230001, China

RECRUITING

Investigational Site Number : 1560009

Shanghai, 200433, China

RECRUITING

Investigational Site Number : 1560003

Wuxi, 214023, China

RECRUITING

Investigational Site Number : 1560006

Zhengzhou, 450052, China

RECRUITING

Investigational Site Number : 2030002

Olomouc, 779 00, Czechia

RECRUITING

Investigational Site Number : 2030001

Prague, 150 06, Czechia

RECRUITING

Investigational Site Number : 2080001

Copenhagen, 2100, Denmark

RECRUITING

Investigational Site Number : 2460001

Helsinki, 00290, Finland

RECRUITING

Investigational Site Number : 2500005

Le Plessis-Robinson, 92350, France

RECRUITING

Investigational Site Number : 2500006

Marseille, 13915, France

RECRUITING

Investigational Site Number : 2500002

Pessac, 33604, France

RECRUITING

Investigational Site Number : 2500003

Saint-Herblain, 44800, France

RECRUITING

Investigational Site Number : 2500001

Suresnes, 92151, France

RECRUITING

Investigational Site Number : 2760003

Munich, 81337, Germany

RECRUITING

Investigational Site Number : 3480001

Budapest, 1085, Hungary

RECRUITING

Investigational Site Number : 2500004

Mumbai, 400026, India

RECRUITING

Investigational Site Number : 3760001

Petah Tikva, 4941492, Israel

RECRUITING

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

Milan, Milano, 20122, Italy

RECRUITING

Investigational Site Number : 3800005

Padua, Padova, 35128, Italy

RECRUITING

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

Palermo, 90127, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo-Site Number : 3800003

Pavia, 27100, Italy

RECRUITING

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

Siena, 53100, Italy

RECRUITING

Brigham & Women's Hospital- Site Number : 8400016

Joso-Shi, Massachusetts, 3030005, Japan

RECRUITING

Investigational Site Number : 5280001

Groningen, 9713 GR, Netherlands

RECRUITING

Investigational Site Number : 5780001

Oslo, 0372, Norway

RECRUITING

Investigational Site Number : 4100004

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 03080, South Korea

RECRUITING

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03722, South Korea

RECRUITING

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, 06351, South Korea

RECRUITING

Investigational Site Number : 7240002

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

RECRUITING

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Investigational Site Number : 7240001

Santander, Cantabria, 39008, Spain

RECRUITING

Investigational Site Number : 7240004

Valencia, 46026, Spain

RECRUITING

Investigational Site Number : 7520001

Gothenburg, 413 45, Sweden

RECRUITING

Related Links

• EFC17801 Plain Language Results Summary

MeSH Terms

Interventions

belumosudil; Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 13, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): January 29, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CZ (2); ES (4); DE (1); IN (1); IL (1); FR (5); KR (4); CN (9); DK (1); FI (1); NO (1); US (31); BE (2); IT (5); JP (1); SE (1); HU (1); NL (1); AU (3); CA (3)