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NCT06082037 · ClinicalTrials.gov registry record · Phase 3
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
A Phase 3 study of Lung Transplant Rejection, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT06082037 is a Phase 3 study of Lung Transplant Rejection that is actively recruiting participants, run by Sanofi. The registered enrollment target is 180 participants, below the 631-participant average among 6 other Lung Transplant Rejection trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06082037, a Phase 3 study of Lung Transplant Rejection, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Belumosudil
- DRUG Azithromycin
Study Locations (20)
Florida
- Mayo Clinic- Site Number : 8400031 - Jacksonville
- University of Miami - Jackson Memorial Hospital- Site Number : 8400030 - Miami
- Advent Health Transplant Institute- Site Number : 8400023 - Orlando
- Tampa General Hospital- Site Number : 8400015 - Tampa
New York
- NYU Langone Medical Center- Site Number : 8400001 - New York
- Icahn School of Medicine at Mount Sinai- Site Number : 8400037 - New York
- New York Presbyterian/Columbia University Medical Center- Site Number : 8400002 - New York
California
- David Geffen School of Medicine at UCLA- Site Number : 8400020 - Los Angeles
- Stanford Health Care - Center for Advance Lung Disease- Site Number : 8400008 - Stanford
Illinois
- Northwestern University- Site Number : 8400003 - Chicago
- Loyola University Medical Center- Site Number : 8400025 - Maywood
Maryland
- University of Maryland School of Medicine- Site Number : 8400009 - Baltimore
- ~Johns Hopkins University School of Medicine- Site Number : 8400034 - Baltimore
Michigan
- University of Michigan Hospital - 1500 E Medical Center Dr- Site Number : 8400014 - Ann Arbor
- Corewell Health- Site Number : 8400010 - Grand Rapids
Alabama
- UAB Lung Health Center- Site Number : 8400026 - Birmingham
Arizona
- St. Joseph's Hospital & Medical Center - Norton Thoracic Research Department- Site Number : 8400019 - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-10-10 |
| Est. Completion | 2028-06-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06082037
The ClinicalTrials.gov registry entry for NCT06082037 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 631-participant average among 6 other Lung Transplant Rejection trials with a reported enrollment target (71% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lung Transplant Rejection appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06082037 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, New York, California.
Frequently Asked Questions
What is clinical trial NCT06082037 about?
NCT06082037 is a clinical study titled "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 fe...
What is the current status of trial NCT06082037?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2023-10-10. Estimated completion is 2028-06-02.
What conditions does trial NCT06082037 study?
This clinical trial studies the following conditions: Lung Transplant Rejection.
What interventions are being tested in trial NCT06082037?
The interventions under investigation include: Placebo (DRUG), Belumosudil (DRUG), Azithromycin (DRUG).
Who is sponsoring clinical trial NCT06082037?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06082037 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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