Brief 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.
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.
Brief Title
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
800-633-1610
Central Contact Phone Ext
option 6
Central Contact Email
contact-us@sanofi.com
Completion Date
Completion Date Type
Estimated
Conditions
Lung Transplant Rejection
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 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
* 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
Inclusion 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 azithromycin (≥250 mg/day, at least 3 times a week) prior to randomization
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06082037
Org Class
Industry
Org Full Name
Sanofi
Org Study Id
EFC17801
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official 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
Primary Outcomes
Outcome Measure
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
Outcome Time Frame
Baseline to Week 26
Secondary Ids
Secondary Id
U1111-1280-6777
Secondary Id
2023-503462-23
Secondary Outcomes
Outcome Description
Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Response rate at Week 26
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Absolute change from baseline to Week 26 in FEV1
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Absolute change from baseline to Week 26 in percent predicted FEV1
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Percent change from baseline to Week 26 in forced vital capacity (FVC)
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Absolute change from baseline to Week 26 in FVC
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Absolute change from baseline to Week 26 in percent predicted FVC
Outcome Description
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
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Time to CLAD progression during the double-blind treatment period
Outcome Time Frame
Up to 7 days after the administration of last dose of study drug
Outcome Measure
Time to re-transplantation or death
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Percent change from baseline to Week 26 in 6-minute walk distance
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Absolute change from baseline to Week 26 in 6-minute walk distance
Outcome Description
Total score and scores by domain
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)
Outcome Description
Visual analogue scale and individual dimensions
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Change from baseline to Week 26 in EQ-5D-5L
Outcome Description
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile V2.1 (domain scores)
Outcome Time Frame
Baseline to Week 26
Outcome Measure
Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1
Outcome Description
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
Outcome Time Frame
Up to 7 days after the administration of last dose of study drug
Outcome Measure
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ali Mansour
Investigator Email
amansour@montefiore.org
Investigator Sponsor Organization
External
Study Department
Please Specify
Study Division
Please Specify
MeSH Terms
BELUMOSUDIL
AZITHROMYCIN
ERYTHROMYCIN
MACROLIDES
POLYKETIDES
LACTONES
ORGANIC CHEMICALS