A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis

Completed · Phase 2

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

This Phase 2 study is to be conducted to evaluate the safety, tolerability, and activity of 400 mg of belumosudil orally (PO) once-daily (QD) compared to Best Supportive Care (BSC) in male and postmenopausal/surgically sterilized female subjects with Idiopathic Pulmonary Fibrosis (IPF). The primary objectives are to evaluate the: * Change in Forced Vital Capacity (FVC) from baseline to 24 weeks after dosing with belumosudil 400 mg PO QD in subjects with IPF compared to BSC * Safety and tolerability of belumosudil 400 mg PO QD when administered for 24 weeks to subjects with IPF compared to BSC

Key facts

Study ID

NCT02688647

Run by

Kadmon Corporation, LLC

People needed

76

Starts

2016-05-26

Expected to finish

2021-04-13

Last updated by the study team

2022-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A subject had to meet all of the following criteria to be eligible for the study:
• Adult male and postmenopausal/surgically sterilized female subjects at least 18 years of age (if female, was surgically sterilized [i.e., total hysterectomy, or bilateral salpingo-oophorectomy]).
• Able to provide written informed consent before the performance of any study specific procedures.
• IPF diagnosis within 5 years before study entry, proven according to the American Thoracic Society/European Respiratory Society consensus conference criteria, with surgical lung biopsy. In the absence of a surgical lung biopsy, high-resolution computerized tomography (HRCT) consistent with usual interstitial pneumonitis.
• Resting state pulse oximeter oxygen saturation (SpO2) ≥ 88% with or without supplemental oxygen, Forced Vital Capacity % (FVC%) ≥ 50% normal predicted value, and diffusing capcity (in the lung) of carbon monoxide (DLCO) ≥ 30% normal predicted value at baseline.
• Men with partners of childbearing potential willing to use 2 medically acceptable methods of contraception during the trial and for 3 months after the last dose of study drug. Effective birth control includes:
• Intrauterine device plus 1 barrier method
• Stable doses of hormonal contraception for ≥ 3 months (e.g., oral, injectible, implant, transdermal) plus 1 barrier method
• 2 barrier methods. Effective barrier methods were male or female condoms, diaphragms, and spermicides (creams or gels containing a chemical to kill sperm)
• Vasectomy.
• Have adequate bone marrow function:
• Absolute neutrophil count > 1500/mm\^3
• Hemoglobin (Hb) > 9.0 g/L
• Platelets > 100,000/mm\^3
• Willing to complete all study measurements and assessments in compliance with protocol
• Had either received pirfenidone and/or nintedanib or offered both treatments (with last dose administered at least 1 month before the expected start of study drug dosing). If either or both pirfenidone and nintedanib treatment had not been given, then documentation that the subject was offered both treatments must have been documented.

You may not qualify if…

• A subject who met any of the following criteria was ineligible for the study:
• Interstitial lung disease caused by conditions other than IPF
• Severe concomitant illness limiting life expectancy (< 1 year)
• DLCO < 30% predicted
• Residual volume (RV) ≥ 120% predicted
• Obstructive lung disease: Forced Expiratory Volume in 1 Second (FEV1/FVC ratio < 0.70)
• Documented sustained improvement of the subject's IPF condition up to 12 months before study entry with or without IPF-specific therapy
• Pulmonary infection or upper respiratory tract infection (URTI) within 4 weeks before study entry
• Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (e.g., pulmonary function tests [PFTs])
• Chronic heart failure with New York Heart Association Class III/IV or known left ventricular ejection fraction < 25%
• Moderate to severe hepatic impairment (i.e., Child-Pugh Class B or C)
• Estimated creatinine clearance < 30 mL/min
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.0 * upper limit of normal (ULN)
• Hb < 75% of the lower limit of normal
• Systolic blood pressure < 100 mmHg
• Pregnant or breastfeeding female subject
• Men whose partner is pregnant or breastfeeding
• Current drug or alcohol dependence
• Chronic treatment with the following drugs within 4 weeks of study entry and during the study:
• Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine
• Antifibrotic drugs including pirfenidone, nintedanib, D-penicillamine, colchicine, tumor necrosis factor-alpha blockers, imatinib, and interferon-γ
• Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day)
• Oral anticoagulants prescribed for IPF
• Treatment with endothelin receptor antagonists within 4 weeks before study entry
• Systemic treatment within 4 weeks before study entry with cyclosporine A or tacrolimus, everolimus, or sirolimus (calcineurin or mammalian target of rapamycin inhibitors)

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• UC Davis Medical Center, Division of Pulmonary/CC/SM — Sacramento, California, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• Pulmonary Disease Specialists, PA, d/b/a PDS Research — Kissimmee, Florida, United States
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States
• Piedmont Healthcare Pulmonary and Critical Care Research — Austell, Georgia, United States
• Pulmonix, LLC — Greensboro, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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