New drug shows promise in slowing lung scarring
NCT ID NCT03865927
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an experimental drug called GKT137831 in 58 people with idiopathic pulmonary fibrosis (IPF), a disease that causes progressive lung scarring. The drug aims to reduce lung damage caused by harmful molecules called reactive oxygen species. Researchers measured changes in blood markers of oxidative stress and collagen breakdown to see if the drug could slow disease progression.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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58 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 40-85 years old. 2. A diagnosis of IPF that fulfills current American Thoracic Society (ATS) Consensus Criteria. 3. IPF duration \<5 years, based on the date of definitive diagnosis. 4. Ability and willingness to give informed consent and adhere to study requirements. 5. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>70% of predicted values Exclusion Criteria: 1. Diagnosis of major comorbidities expected to interfere with study participation 2. 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. 3. The occurrence of any acute infection requiring systemic antibiotic therapy within 2 weeks prior to Screening (Visit 1). 4. 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. 5. Treatment with any investigational agent within 4 weeks of Screening (Visit 1) or 5 half-lives of the investigational medicinal product (whichever is longer). 6. 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. 7. Subjects with known hypersensitivity to GKT137831 or its excipients (e.g. capsule "bulking" agents). 8. A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin \< 10.0 g/dL (or 6.2 mmol/L). 9. Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, congestive heart failure (NYHA Class III or IV), or stroke, including a transient ischemic attack. 10. Evidence of cardiac conducting abnormalities, defined as second or third degree atrial-ventricular (AV) block not successfully treated with a pacemaker, or a personal or family history of long QT syndrome (QTc interval \>450 msec for males or 470 msec for females). 11. End-stage renal disease requiring dialysis. 12. Undergoing transplantation evaluation, or listed with the United Network for Organ Sharing (UNOS) as a lung transplantation candidate at the time of enrollment in this trial. 13. Liver function tests (transaminases, alkaline phosphatase, direct and total bilirubin) \>3x upper limit of normal values
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Temple University Medical Center
Philadelphia, Pennsylvania, 19140, United States
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Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
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Other studies related to the condition(s) this trial covers.
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