RecruitingPhase 2NCT06476132

Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients

Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients: A Randomized, Multicenter, Double Blind, Placebo-Controlled Trial (CTOT-47)


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

234 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD. The primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Belumosudil and a drug called Placebo for Belumosudil for people with lung transplant. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBelumosudil

Participants will receive Belumosudil 200 mg daily (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS for a duration of one year from randomization.

DRUGPlacebo for Belumosudil

Participants will receive Placebo for Belumosudil 200 mg daily (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS for a duration of one year from randomization.


Locations(12)

University of California, Los Angeles (Site #: 71123)

Los Angeles, California, United States

Stanford University (Site #: 71141)

Palo Alto, California, United States

Johns Hopkins (Site #: 71119)

Baltimore, Maryland, United States

University of Minnesota (Site 71151)

Minneapolis, Minnesota, United States

Washington University (Site #: 71157)

St Louis, Missouri, United States

NYU Langone Health (Site #: 71177)

New York, New York, United States

Duke University (Site #: 71139)

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center (Site #: 71017)

Cincinnati, Ohio, United States

Cleveland Clinic (Site #: 71101)

Cleveland, Ohio, United States

University of Pennsylvania (Site #: 71111)

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center (Site #: 71174)

Nashville, Tennessee, United States

University Health Network/Toronto General Hospital (Site #: 71121)

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06476132


Related Trials