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Using Belumosudil to prevent lung transplant complications

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

PHASE2 · National Institute of Allergy and Infectious Diseases (NIAID) · NCT06476132

This study is testing if a new drug called Belumosudil can help prevent lung transplant complications in high-risk patients who have signs of rejection or inflammation.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment234 (estimated)
Ages12 Years and up
SexAll
SponsorNational Institute of Allergy and Infectious Diseases (NIAID) (nih)
Drugs / interventionsalemtuzumab
Locations12 sites (Los Angeles, California and 11 other locations)
Trial IDNCT06476132 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Belumosudil, an investigational drug, in preventing Chronic Lung Allograft Dysfunction (CLAD) in high-risk lung transplant recipients. Participants who have had a lung biopsy showing signs of rejection or inflammation will receive Belumosudil for 52 weeks alongside their usual care. The study aims to determine if this drug can reduce inflammation and scarring in the transplanted lungs, potentially improving patient outcomes. Eligible participants must be lung transplant recipients aged 12 years or older with specific biopsy results indicating allograft injury.

Who should consider this trial

Good fit: Ideal candidates are lung transplant recipients aged 12 and older who have evidence of acute rejection or inflammation in their recent lung biopsy.

Not a fit: Patients without recent qualifying biopsies showing acute rejection or inflammation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of CLAD in lung transplant recipients, improving their long-term health and transplant success.

How similar studies have performed: While Belumosudil is already approved for treating chronic graft-versus-host disease, its application in preventing CLAD is novel and has not been extensively tested in similar studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant and/or parent or guardian must be able to understand the purpose of the study, willing to participate, sign the informed consent, and if applicable assent.
2. Single or bilateral lung transplant recipient age ≥ 12 years
3. A qualifying biopsy obtained 60 to 550 days after lung transplant with evidence of allograft injury histology; a qualifying biopsy must have one or more of the following features alone or in combination: Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP), or Acute Lung Injury (ALI). The presence of any grade AR (A1 or greater) or LB (B1 or greater) qualifies for inclusion
4. Females of reproductive potential and males with female partners of reproductive potential must agree to use effective contraception during treatment with belumosudil or placebo and for at least 3 months after the last dose. Participants must agree to refrain from donating or cryopreserving sperm, eggs (ova or ovocytes) for the purpose of reproduction during treatment with belumosudil or placebo and for at least 3 months after the last dose.
5. Meeting hematologic laboratory criteria: absolute neutrophil count (ANC) \>= 0.5 x 10(9)/L and platelet count \>= 50 x 10(9)/L within 30 days of enrollment
6. Meeting all blood chemistry laboratory criteria: aspartate aminotransferase (AST) or alanine transaminase (ALT) \< 2x upper limit of normal (ULN), bilirubin \< 1.5x ULN unless due to Gilbert's syndrome, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 within 30 days of enrollment
7. Cytomegalovirus (CMV) polymerase chain reaction (PCR) negative within 30 days of enrollment
8. In the absence of contraindications, must have received adult vaccinations or documented immunity as outlined in current National Institute of Allergy and Infectious Diseases (NIAID) Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials
9. Receiving Calcineurin Inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen

Exclusion Criteria:

1. Multi-organ transplants involving more than one organ type (e.g., heart-lung)
2. Prior organ transplant or prior bone marrow transplant/hematopoietic stem cell transplantation
3. Greater than 120 days after a qualifying biopsy
4. Clinical AMR prior to enrollment. Subclinical AMR is permitted if 90 days or greater prior to enrollment.
5. Diagnosed with probable or definite CLAD according to International Society for Heart and Lung Transplantation (ISHLT) guidelines prior to enrollment.
6. Posttransplant treatment with anti-thymocyte globulin within 30 days or alemtuzumab or any other prohibited medication within 90 days prior to enrollment.
7. Epstein-Barr virus (EBV) seronegative recipient who received EBV positive donor lung(s).
8. Treatment with any other investigational pharmacologic agent within 30 days prior to enrollment.
9. Significant active uncontrolled infection which, in the opinion of the investigator, would place the participant at increased risk.
10. Current use of sirolimus or everolimus.
11. Recipient human immunodeficiency virus (HIV) positive.
12. Recipient Hepatitis B surface antigen positive or Hepatitis B core antibody positive.
13. Received lung(s) from a donor with known Hepatitis B virus (HBV) including Hepatitis B core antibody positive donors.
14. Recipient history of Hepatitis C, Hepatitis C seropositive, or received lung(s) from a donor with known Hepatitis C (participants who have 3 months of documented consecutive undetected Hepatitis C virus PCR after treatment or spontaneous clearance will not be excluded).
15. History of clinically significant surgical factors (such as phrenic nerve damage, transplant lung resection, chest wall surgery), or mechanical factors (such as posttransplant airways disease including bronchial dehiscence, stenosis, dilation, or stent placement, pleural disease) that impedes lung function.
16. Past or current medical problems, psychosocial concerns, or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose undue risk from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
17. Pregnant or breastfeeding

Where this trial is running

Los Angeles, California and 11 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lung Transplant, Belumosudil, CLAD, Acute Rejection, Lymphocytic Bronchiolitis, Organizing Pneumonia, Acute Lung Injury

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.