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

ConditionLung Transplant Rejection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanofi

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Belumosudil

    Drug

    Tablet, Oral

  • Azithromycin

    Drug

    Depends on pharmaceutical presentation, Oral

  • Placebo

    Drug

    Tablet, Oral

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Belumosudil + AzithromycinExperimental treatment 2 interventions
Group B: Placebo + AzithromycinPlacebo comparator 2 interventions

Trial outcomes

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

Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline

Time frame
Baseline to Week 26
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Meiji Seika Pharma Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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