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Small Molecule Inhibitor

Belumosudil plus maintenance IS for Lung Transplant (CLAD Trial)

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years
Awards & highlights

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.

Who is the study for?
This trial is for lung transplant recipients at high risk of developing CLAD, who have had a recent biopsy showing rejection or inflammation. Participants must be on usual care and medication post-transplant. Specific conditions like Acute Rejection, Lymphocytic Bronchiolitis, Organizing Pneumonia, or Acute Lung Injury in the biopsy qualify them.
What is being tested?
The study tests if Belumosudil can prevent Chronic Lung Allograft Dysfunction (CLAD) when taken for 52 weeks alongside standard post-transplant care. It compares the effectiveness of Belumosudil plus maintenance immunosuppression against a placebo with maintenance immunosuppression.
What are the potential side effects?
Potential side effects are not detailed here but may include those associated with immune system suppression such as increased infection risk and possible drug-specific reactions related to inflammation and scarring reduction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time from randomization to the first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria), lung retransplant, or death
Secondary study objectives
Frequency of Acute Lung Injury (ALI)
Frequency of Acute Rejection (AR)
Frequency of Lymphocytic Bronchiolitis (LB)
+4 more

Side effects data

From 2014 Phase 2 trial • 8 Patients • NCT02106195
25%
Transaminase increased
13%
Nephrolithiasis
13%
Nausea
13%
Vomiting
13%
Anastomotic ulcer
13%
Somnolence
13%
Pyrexia
13%
Anastomotic ulder
13%
Hypokalemia
13%
Rib Fracture
13%
Fall
13%
Tooth ache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belumosudil 200 mg PO QD

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Belumosudil plus maintenance ISExperimental Treatment1 Intervention
Eligible lung transplant recipients who experience a qualifying biopsy 90 to 410 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.
Group II: Placebo + maintenance ISPlacebo Group1 Intervention
Eligible lung transplant recipients who experience a qualifying biopsy 90 to 410 days posttransplant will be randomized into the study. Placebo plus maintenance immunosuppression (IS) will be administered for one year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belumosudil
2018
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,298 Previous Clinical Trials
5,501,137 Total Patients Enrolled
5 Trials studying Lung Transplant
1,424 Patients Enrolled for Lung Transplant
Scott M. Palmer, M.D., M.H.S.Study ChairDuke University Medical Center: Transplantation
~156 spots leftby May 2027