A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study, Followed by Open-label Extensions, to Evaluate the Efficacy of Oral Belumosudil in Adult Participants With Chronic Lung Allograft Dysfunction (CLAD) Following Bilateral Lung Transplantation

Status: Recruiting
Location: See all (77) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham- Site Number : 8400026
RECRUITING
Birmingham
Arizona
St. Joseph's Hospital and Medical Center- Site Number : 8400019
RECRUITING
Phoenix
California
University of California Los Angeles Medical Center- Site Number : 8400020
RECRUITING
Los Angeles
Stanford Hospital- Site Number : 8400008
RECRUITING
Stanford
Florida
Mayo Clinic Hospital Jacksonville- Site Number : 8400031
RECRUITING
Jacksonville
Jackson Memorial Hospital- Site Number : 8400030
RECRUITING
Miami
AdventHealth Orlando- Site Number : 8400023
RECRUITING
Orlando
Tampa General Hospital - Tampa - General Circle- Site Number : 8400015
RECRUITING
Tampa
Georgia
Emory University Hospital- Site Number : 8400027
RECRUITING
Atlanta
Iowa
University of Iowa- Site Number : 8400032
RECRUITING
Iowa City
Illinois
Northwestern University- Site Number : 8400003
RECRUITING
Chicago
Loyola University Medical Center- Site Number : 8400025
RECRUITING
Maywood
Massachusetts
Children's Hospital Boston/Brigham & Women's Hospital (CHB/BWH) - Adult Cystic Fibrosis Program- Site Number : 8400016
RECRUITING
Boston
Maryland
Johns Hopkins Hospital- Site Number : 8400034
RECRUITING
Baltimore
University of Maryland Medical Center (UMMC) - UMMC Midtown Campus location- Site Number : 8400009
RECRUITING
Baltimore
Michigan
University of Michigan Health System - Ann Arbor- Site Number : 8400014
RECRUITING
Ann Arbor
Corewell Health- Site Number : 8400010
RECRUITING
Grand Rapids
North Carolina
Duke University Medical Center- Site Number : 8400017
RECRUITING
Durham
New York
Columbia University Medical Center - New York- Site Number : 8400002
RECRUITING
New York
Icahn School of Medicine at Mount Sinai- Site Number : 8400037
RECRUITING
New York
NYU Langone Medical Center- Site Number : 8400001
RECRUITING
New York
Montefiore Medical Center - Moses Campus- Site Number : 8400036
RECRUITING
The Bronx
Ohio
Cleveland Clinic - Cleveland- Site Number : 8400005
RECRUITING
Cleveland
The Ohio State University- Site Number : 8400028
RECRUITING
Columbus
Pennsylvania
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006
RECRUITING
Philadelphia
Temple University Hospital- Site Number : 8400007
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center- Site Number : 8400018
RECRUITING
Nashville
Texas
Baylor University Medical Center- Site Number : 8400011
RECRUITING
Dallas
University of Texas - Southwestern Medical Center- Site Number : 8400013
RECRUITING
Dallas
Baylor College of Medicine- Site Number : 8400024
RECRUITING
Houston
Houston Methodist Hospital- Site Number : 8400021
RECRUITING
Houston
University Health System - San Antonio- Site Number : 8400035
RECRUITING
San Antonio
Virginia
Inova Fairfax Hospital- Site Number : 8400004
RECRUITING
Falls Church
Other Locations
Australia
Investigational Site Number : 0360001
RECRUITING
Brisbane
Investigational Site Number : 0360002
RECRUITING
Murdoch
Investigational Site Number : 0360003
RECRUITING
Sydney
Austria
Investigational Site Number : 0400001
RECRUITING
Vienna
Belgium
Investigational Site Number : 0560001
RECRUITING
Leuven
Investigational Site Number : 0560002
RECRUITING
Yvoir
Canada
Investigational Site Number : 1240002
RECRUITING
Edmonton
Investigational Site Number : 1240004
RECRUITING
Toronto
Investigational Site Number : 1240001
RECRUITING
Vancouver
China
Investigational Site Number : 1560004
RECRUITING
Beijing
Investigational Site Number : 1560002
RECRUITING
Chengdu
Investigational Site Number : 1560008
RECRUITING
Fuzhou
Investigational Site Number : 1560007
RECRUITING
Guangzhou
Investigational Site Number : 1560001
RECRUITING
Hangzhou
Investigational Site Number : 1560005
RECRUITING
Hefei
Investigational Site Number : 1560009
RECRUITING
Shanghai
Investigational Site Number : 1560003
RECRUITING
Wuxi
Investigational Site Number : 1560006
RECRUITING
Zhengzhou
Denmark
Investigational Site Number : 2080001
RECRUITING
Copenhagen
Finland
Investigational Site Number : 2460001
RECRUITING
Helsinki
France
Investigational Site Number : 2500005
RECRUITING
Le Plessis-robinson
Investigational Site Number : 2500006
RECRUITING
Marseille
Investigational Site Number : 2500004
RECRUITING
Paris
Investigational Site Number : 2500002
RECRUITING
Pessac
Investigational Site Number : 2500003
RECRUITING
Saint-herblain
Investigational Site Number : 2500001
RECRUITING
Suresnes
Germany
Investigational Site Number : 2760003
RECRUITING
Munich
Hungary
Investigational Site Number : 3480001
RECRUITING
Budapest
Israel
Investigational Site Number : 3760001
RECRUITING
Petah Tikva
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano-Site Number : 3800001
RECRUITING
Milan
Investigational Site Number : 3800005
RECRUITING
Padua
IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)-Site Number : 3800004
RECRUITING
Palermo
Fondazione IRCCS Policlinico San Matteo-Site Number : 3800003
RECRUITING
Pavia
Azienda Ospedaliera Universitaria Senese UOC Malattie Respiratorie e Trapianto Polmonare-Site Number : 3800002
RECRUITING
Siena
Netherlands
Investigational Site Number : 5280001
RECRUITING
Groningen
Norway
Investigational Site Number : 5780001
RECRUITING
Oslo
Republic of Korea
Investigational Site Number : 4100001
RECRUITING
Seoul
Investigational Site Number : 4100002
RECRUITING
Seoul
Investigational Site Number : 4100003
RECRUITING
Seoul
Investigational Site Number : 4100004
RECRUITING
Yangsan
Spain
Investigational Site Number : 7240002
RECRUITING
A Coruña
Investigational Site Number : 7240003
RECRUITING
Barcelona
Investigational Site Number : 7240001
RECRUITING
Santander
Investigational Site Number : 7240004
RECRUITING
Valencia
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2028-06-02
Participants
Target number of participants: 180
Treatments
Experimental: Belumosudil + Azithromycin
Participants will receive 200 mg belumosudil orally once daily
Placebo_comparator: Placebo + Azithromycin
Participants will receive placebo orally once daily
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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