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NCT Number: NCT06082037

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

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.

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Key information

Conditions

Lung Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 0360003, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belumosudil

Drug

Tablet, Oral

Other names: REZUROCK

Azithromycin

Drug

Depends on pharmaceutical presentation, Oral

Placebo

Drug

Tablet, Oral

Primary outcomes

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

    Time frame: Baseline to Week 26

Secondary outcomes

  1. 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

  2. Absolute change from baseline to Week 26 in FEV1

    Time frame: Baseline to Week 26

  3. Absolute change from baseline to Week 26 in percent predicted FEV1

    Time frame: Baseline to Week 26

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

    Time frame: Baseline to Week 26

  5. Absolute change from baseline to Week 26 in FVC

    Time frame: Baseline to Week 26

  6. Absolute change from baseline to Week 26 in percent predicted FVC

    Time frame: Baseline to Week 26

  7. 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

  8. Time to re-transplantation or death

    Time frame: Up to 7 days after the administration of last dose of study drug

  9. Percent change from baseline to Week 26 in 6-minute walk distance

    Time frame: Baseline to Week 26

  10. Absolute change from baseline to Week 26 in 6-minute walk distance

    Time frame: Baseline to Week 26

  11. Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)

    Time frame: Baseline to Week 26

    Total score and scores by domain

  12. Change from baseline to Week 26 in EQ-5D-5L

    Time frame: Baseline to Week 26

    Visual analogue scale and individual dimensions

  13. 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)

  14. 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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Meiji Seika Pharma Co., Ltd.

Registry information

Official study title

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

Acronym: ROCKaspire

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Oct 13, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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