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RECRUITING
NCT06476132
PHASE2

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

234

Start Date

2025-03-12

Completion Date

2027-06-30

Last Updated

2026-01-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Belumosudil

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.

DRUG

Placebo 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 (10)

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

Los Angeles, 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