GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis (NCT03865927) | Clinical Trial Compass
CompletedPhase 2
GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis
United States58 participantsStarted 2020-09-07
Plain-language summary
A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug will decrease pulmonary injury due to reactive oxygen species (ROS) generated by NOX enzymes, which are believed to play an important role in the development of IPF. Treatment with GKT137831 could result in significant benefit for a lung disease that has, until now, been almost invariably inexorable.
This clinical trial represents the bedside application of a series of NOX translational and basic studies and discoveries, over several years, from the laboratory of Dr. Victor Thannickal.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age between 40-85 years old.
✓. A diagnosis of IPF that fulfills current American Thoracic Society (ATS) Consensus Criteria.
✓. IPF duration \<5 years, based on the date of definitive diagnosis.
✓. Ability and willingness to give informed consent and adhere to study requirements.
✓. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>70% of predicted values
Exclusion criteria
✕. Diagnosis of major comorbidities expected to interfere with study participation
✕. History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen \<10 ng/dl. NOX inhibition is not known to promote cancer, and these criteria are within current guidelines.
✕. The occurrence of any acute infection requiring systemic antibiotic therapy within 2 weeks prior to Screening (Visit 1).
What they're measuring
1
Surrogate Biomarker of Oxidative Stress by Mass Spectroscopy
. Treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, etc.), given increased risks of opportunistic infections.
✕. Treatment with any investigational agent within 4 weeks of Screening (Visit 1) or 5 half-lives of the investigational medicinal product (whichever is longer).
✕. Fertile women who do not agree to contraception or abstinence, or who are breast feeding. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.
✕. Subjects with known hypersensitivity to GKT137831 or its excipients (e.g. capsule "bulking" agents).
✕. A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin \< 10.0 g/dL (or 6.2 mmol/L).