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Lung TransplantPhase 2CLADNCT06476132

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

A Phase 2 study testing Belumosudil in people with Lung Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Lung Transplant
What is being tested?
Belumosudil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
12 sitesin 2 countries
Study dates
12 Mar 2025to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • Single or bilateral lung transplant recipient age ≥ 12 years
  • A qualifying biopsy obtained 60 to 760 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
  • 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.
  • 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
  • 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
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  • Cytomegalovirus (CMV) polymerase chain reaction (PCR) negative or, if detected, <200 IU/ml in the absence of any signs of active infection, within 30 days of enrollment
  • 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
  • Intent to receive calcineurin inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen

Who cannot join

  • Multi-organ transplants involving more than one organ type (e.g., heart-lung)
  • Prior organ transplant or prior bone marrow transplant/hematopoietic stem cell transplantation
  • Greater than 160 days after a qualifying biopsy
  • Active AMR unless resolved and no treatments with prohibited medications for > 90 days prior to enrollment
  • Diagnosed with probable or definite CLAD according to International Society for Heart and Lung Transplantation (ISHLT) guidelines prior to enrollment.
  • Posttransplant treatment with anti-thymocyte globulin within 30 days or alemtuzumab or any other prohibited medication within 90 days prior to enrollment.
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  • Epstein-Barr virus (EBV) seronegative recipient who received EBV positive donor lung(s).
  • Treatment with any other investigational pharmacologic agent within 30 days prior to enrollment.
  • Significant active uncontrolled infection which, in the opinion of the investigator, would place the participant at increased risk.
  • Current use of sirolimus or everolimus.
  • Recipient human immunodeficiency virus (HIV) positive.
  • Recipient Hepatitis B surface antigen positive or Hepatitis B core antibody positive.
  • Received lung(s) from a donor with known Hepatitis B virus (HBV) including Hepatitis B core antibody positive donors.
  • Incompletely treated Hepatitis C (absence of ongoing treatment and post-transplant negative HCV PCR)
  • 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.
  • 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.
  • Pregnant or breastfeeding

Trial locations and contacts

12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

12 sites in 2 countries

United States11 sites, 11 recruiting

  • Johns Hopkins (Site #: 71119)

    Baltimore, Maryland, 21287

    Viktoryiya Livchits, 607-591-4747, vlivchi1@jh.edu

    Recruiting

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

    Cincinnati, Ohio, 45229

    Maryam Mysorewala, 513-636-4578, maryam.mysorewala@cchmc.org

    Recruiting

  • Cleveland Clinic (Site #: 71101)

    Cleveland, Ohio, 44195

    Abigail Camiener, 216-390-5108, camiena3@ccf.org

    Recruiting

  • Duke University (Site #: 71139)

    Durham, North Carolina, 27710

    Katelyn Arroyo, 919-684-6140, katelyn.arroyo@duke.edu

    Recruiting

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

    Los Angeles, California, 90095

    Paul Lopez, 310-794-1999, PLopez@mednet.ucla.edu

    Recruiting

  • University of Minnesota (Site 71151)

    Minneapolis, Minnesota, 55455

    Dean Krueger, 612-301-4015, krue0100@umn.edu

    Recruiting

  • Vanderbilt University Medical Center (Site #: 71174)

    Nashville, Tennessee, 37232

    Briana Swanner, 615-327-7232, briana.swanner@vumc.org

    Recruiting

  • NYU Langone Health (Site #: 71177)

    New York, New York, 10016

    Cecilia Deterville, 212-263-3620, cecilia.deterville@nyulangone.org

    Recruiting

  • Stanford University (Site #: 71141)

    Palo Alto, California, 94304

    Hannah Mudgett, 650-319-6877, hmudgett@stanford.edu

    Recruiting

  • University of Pennsylvania (Site #: 71111)

    Philadelphia, Pennsylvania, 19104

    Maddy Fair, 215-573-4701, Maddy.fair@pennmedicine.upenn.edu

    Recruiting

  • Washington University (Site #: 71157)

    St Louis, Missouri, 63130

    Brigitte Mittler, 314-747-1931, b.mittler@wustl.edu

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

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

    Toronto, Ontario

    Lianne Singer, (416)340-4800 ext. 4996, Lianne.Singer@uhn.ca

    Recruiting

Other trials in Canada

About this study

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)

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.

Conditions
Lung Transplant
Being tested
Belumosudil, Placebo for Belumosudil
Keywords
Lung Transplant, Belumosudil, CLAD, Acute Rejection, Lymphocytic Bronchiolitis, Organizing Pneumonia, Acute Lung Injury
Medical subject headings
Organizing Pneumonia, Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelumosudilDrug

    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.

  • Placebo for BelumosudilDrug

    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.

Study groups in NCT06476132
Study groupRoleWhat they receive
Belumosudil plus maintenance ISExperimentalEligible lung transplant recipients who experience a qualifying biopsy 60 to 760 days posttransplant will be randomized into the study. 200 mg of Belumosudil (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS will be administered daily for one year from randomization.
Receives: Drug: Belumosudil
Placebo + maintenance ISPlacebo comparatorEligible lung transplant recipients who experience a qualifying biopsy 60 to 760 days posttransplant will be randomized into the study. Placebo plus maintenance immunosuppression (IS) will be administered for one year
Receives: Drug: Placebo for Belumosudil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from randomization to the first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria), lung retransplant, or death

    Probable CLAD is defined as a >= 20% decline in Forced Expiratory Volume in 1 Second (FEV1) compared to the baseline value on 2 measurements taken at least 3 weeks apart and after exclusion or adequate treatment of potential secondary causes of allograft dysfunction.

    The baseline FEV1 value is defined as the average of the 2 best posttransplant FEV1s taken at least 3 weeks apart

    Measured: From randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years

Secondary outcomes (8)

  1. Time from randomization to first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria) or lung retransplant

    Definite CLAD is a sustained decline in pulmonary function as defined by a persistent decline in lung function meeting the definition of probable CLAD but sustained for a duration of at least 3 months

    Measured: From randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years

  2. Time from randomization to death

    Measured: From date of randomization until the date of death, through study completion; participants are scheduled to be assessed for a minimum of 1 year up to a maximum of 3 years

  3. Time from randomization to first occurrence of the specific CLAD phenotypes of Restrictive Allograft Syndrome (RAS), Bronchiolitis Obliterans Syndrome (BOS), mixed, or undefined

    Measured: From date of randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years

  4. Frequency of Acute Rejection (AR)

    Measured: Number of AR events occurring from date of randomization until date of end of treatment visit, an average of 1 year

  5. Frequency of Lymphocytic Bronchiolitis (LB)

    Measured: Number of LB events occurring from date of randomization until date of end of treatment visit, an average of 1 year.

  6. Frequency of Organizing Pneumonia (OP)

    Measured: Number of OP events occurring from date of randomization until date of end of treatment visit, an average of 1 year.

  7. Frequency of Acute Lung Injury (ALI)

    Measured: Number of ALI events occurring from date of randomization until date of end of treatment visit, an average of 1 year.

  8. Rate of change in lung function measures (forced expiratory volume [FEV1] and forced vital capacity [FVC])

    Measured: Rate of change occurring from date of randomization until date of end of treatment visit, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start12 Mar 2025
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476132
Sponsor's protocol ID
DAIT CTOT-47
Acronym
CLAD
Status last verified
Aug 2026
First submitted
8 May 2024
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belumosudil in people with Lung Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from randomization to the first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria), lung retransplant, or death (time frame: From randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06476132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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