A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Recruiting
Phase 3Interventional Study
Lung Transplant Rejection
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for
This trial is looking for adults who have had a lung transplant for at least a year and are experiencing lung problems despite treatment. Participants will receive either the study drug, belumosudil, or a placebo alongside their standard medication for up to 26 weeks.
Are You a Good Fit for This Trial?
Must be takingAzithromycin
You may be able to join if
I have had a lung transplant for at least 1 year.
I have CLAD Stage 1 or 2 with lung function between 50% and 80% of my baseline.
I have been on azithromycin treatment for at least 8 weeks.
You may not be able to join if
I have lung function worse than 50% of my baseline.
My lung function decline is due to causes other than CLAD.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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City
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Status
Eligibility Criteria
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 azithrom…
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.
Contacts
Trial Transparency email recommended (Toll free number for US & Canada)
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