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

June 1, 2026 updated by: Sanofi

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free number for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • Investigational Site Number : 0360003
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Recruiting
        • Investigational Site Number : 0360001
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Investigational Site Number : 0360002
  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Investigational Site Number : 0400001
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Investigational Site Number : 0560001
      • Yvoir, Belgium, 5530
        • Recruiting
        • Investigational Site Number : 0560002
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Investigational Site Number : 1240002
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Investigational Site Number : 1240001
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Investigational Site Number : 1240004
  • China
      • Beijing, China, 100029
        • Recruiting
        • Investigational Site Number : 1560004
      • Chengdu, China, 610072
        • Recruiting
        • Investigational Site Number : 1560002
      • Fuzhou, China, 350001
        • Recruiting
        • Investigational Site Number : 1560008
      • Guangzhou, China, 510163
        • Recruiting
        • Investigational Site Number : 1560007
      • Hangzhou, China, 310009
        • Recruiting
        • Investigational Site Number : 1560001
      • Hefei, China, 230001
        • Recruiting
        • Investigational Site Number : 1560005
      • Shanghai, China, 200433
        • Recruiting
        • Investigational Site Number : 1560009
      • Wuxi, China, 214023
        • Recruiting
        • Investigational Site Number : 1560003
      • Zhengzhou, China, 450052
        • Recruiting
        • Investigational Site Number : 1560006
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Investigational Site Number : 2030002
      • Prague, Czechia, 150 06
        • Recruiting
        • Investigational Site Number : 2030001
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Investigational Site Number : 2080001
  • Finland
      • Helsinki, Finland, 00029
        • Recruiting
        • Investigational Site Number : 2460001
  • France
      • Le Plessis-Robinson, France, 92350
        • Recruiting
        • Investigational Site Number : 2500005
      • Marseille, France, 13915
        • Recruiting
        • Investigational Site Number : 2500006
      • Paris, France, 75018
        • Recruiting
        • Investigational Site Number : 2500004
      • Pessac, France, 33604
        • Recruiting
        • Investigational Site Number : 2500002
      • Saint-Herblain, France, 44800
        • Recruiting
        • Investigational Site Number : 2500003
      • Suresnes, France, 92151
        • Recruiting
        • Investigational Site Number : 2500001
  • Germany
      • Munich, Germany, 81337
        • Recruiting
        • Investigational Site Number : 2760003
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Investigational Site Number : 3480001
  • Israel
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Investigational Site Number : 3760001
  • Italy
      • Palermo, Italy, 90133
        • Recruiting
        • IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)-Site Number : 3800004
        • Contact:
        • Principal Investigator:
          • Lavinia Martino, Dr.
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo-Site Number : 3800003
        • Contact:
        • Principal Investigator:
          • Federica Briganti, Dr.
      • Siena, Italy, 53100
        • Recruiting
        • Azienda Ospedaliera Universitaria Senese UOC Malattie Respiratorie e Trapianto Polmonare-Site Number : 3800002
        • Contact:
        • Principal Investigator:
          • David Bennett, Dr.
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano-Site Number : 3800001
        • Contact:
        • Principal Investigator:
          • Francesco Blasi, Prof.
    • Padova
      • Padua, Padova, Italy, 35128
        • Recruiting
        • Investigational Site Number : 3800005
  • Japan
      • Tokyo, Japan, 113-8654
        • Recruiting
        • Investigational Site Number : 3920001
  • Netherlands
      • Groningen, Netherlands, 9713 GR
        • Recruiting
        • Investigational Site Number : 5280001
  • Norway
      • Oslo, Norway, 0372
        • Recruiting
        • Investigational Site Number : 5780001
  • South Korea
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Recruiting
        • Investigational Site Number : 4100004
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 03080
        • Recruiting
        • Investigational Site Number : 4100002
      • Seoul, Seoul-teukbyeolsi, South Korea, 06351
        • Recruiting
        • Investigational Site Number : 4100003
      • Seoul, Seoul-teukbyeolsi, South Korea, 03722
        • Recruiting
        • Investigational Site Number : 4100001
  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Investigational Site Number : 7240004
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • Recruiting
        • Investigational Site Number : 7240002
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Investigational Site Number : 7240003
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Investigational Site Number : 7240001
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Investigational Site Number : 7520001
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham- Site Number : 8400026
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • St. Joseph's Hospital and Medical Center- Site Number : 8400019
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles Medical Center- Site Number : 8400020
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center- Site Number : 8400008
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida- Site Number : 8400031
      • Miami, Florida, United States, 33136
        • Recruiting
        • Jackson Memorial Hospital- Site Number : 8400030
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando- Site Number : 8400023
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital - Tampa - General Circle- Site Number : 8400015
    • Georgia
      • Atlanta, Georgia, United States, 30324
        • Recruiting
        • Emory University Hospital- Site Number : 8400027
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University- Site Number : 8400003
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center- Site Number : 8400025
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa- Site Number : 8400032
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland School of Medicine - Baltimore- Site Number : 8400009
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital- Site Number : 8400034
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham & Women's Hospital- Site Number : 8400016
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System - Ann Arbor- Site Number : 8400014
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400010
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai- Site Number : 8400037
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center- Site Number : 8400002
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Perlmutter Cancer Center - Energy Building- Site Number : 8400001
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus- Site Number : 8400036
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center- Site Number : 8400017
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic - Cleveland- Site Number : 8400005
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University- Site Number : 8400028
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital- Site Number : 8400007
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center- Site Number : 8400018
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas - Southwestern Medical Center- Site Number : 8400013
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital- Site Number : 8400021
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine- Site Number : 8400024
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University Health System - San Antonio- Site Number : 8400035
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital- Site Number : 8400004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Placebo
Tablet, Oral
Drug: Azithromycin
Depends on pharmaceutical presentation, Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
Time Frame: Baseline to Week 26
Baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate at Week 26
Time Frame: Baseline to Week 26
Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline
Baseline to Week 26
Absolute change from baseline to Week 26 in FEV1
Time Frame: Baseline to Week 26
Baseline to Week 26
Absolute change from baseline to Week 26 in percent predicted FEV1
Time Frame: Baseline to Week 26
Baseline to Week 26
Percent change from baseline to Week 26 in forced vital capacity (FVC)
Time Frame: Baseline to Week 26
Baseline to Week 26
Absolute change from baseline to Week 26 in FVC
Time Frame: Baseline to Week 26
Baseline to Week 26
Absolute change from baseline to Week 26 in percent predicted FVC
Time Frame: Baseline to Week 26
Baseline to Week 26
Time to CLAD progression during the double-blind treatment period
Time Frame: Baseline to Week 26
Defined as the first of the following events: >10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death
Baseline to Week 26
Time to re-transplantation or death
Time Frame: Up to 7 days after the administration of last dose of study drug
Up to 7 days after the administration of last dose of study drug
Percent change from baseline to Week 26 in 6-minute walk distance
Time Frame: Baseline to Week 26
Baseline to Week 26
Absolute change from baseline to Week 26 in 6-minute walk distance
Time Frame: Baseline to Week 26
Baseline to Week 26
Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)
Time Frame: Baseline to Week 26
Total score and scores by domain
Baseline to Week 26
Change from baseline to Week 26 in EQ-5D-5L
Time Frame: Baseline to Week 26
Visual analogue scale and individual dimensions
Baseline to Week 26
Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1
Time Frame: Baseline to Week 26
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile V2.1 (domain scores)
Baseline to Week 26
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 7 days after the administration of last dose of study drug
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions
Up to 7 days after the administration of last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Meiji Seika Pharma Co., Ltd.

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

January 29, 2029

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

October 7, 2023

First Submitted That Met QC Criteria

October 7, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC17801
  • U1111-1280-6777 (Registry Identifier: ICTRP)
  • 2023-503462-23 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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