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Trial · Interventional

CompletedPhase 2Results postedRegistry data

GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis

Short name GKT137831

This trial does not test a peptide that PepBank tracks.

  • Names NAD+ (nicotinamide adenine dinucleotide), does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Phase 2
Enrollment
58 participants (actual)
Sponsor
University of Alabama at Birmingham · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
7 Sept 2020
Primary completion
30 Nov 2024
Completion
30 Nov 2024
First posted
7 Mar 2019
Last update posted
11 May 2026
Conditions
Idiopathic Pulmonary Fibrosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022202320242025
  1. Ph 2

    GKT137831

    NCT03865927

    7 Sept 2020 to 30 Nov 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Placebo Oral TabletOther
  • GKT137831Drug

Arms2

  • Experimental

    GKT137831

    GKT137831 will be administered orally, at a dose of 400 mg twice daily, for a total of 24 weeks.

  • Placebo comparator

    Placebo Oral Tablet

    Identically-appearing placebo oral tablets will be administered orally, twice daily, for a total of 24 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Surrogate Biomarker of Oxidative Stress by Mass Spectroscopy

    Time frame · From baseline thru week 24

    Registry description

    Changes in concentrations of circulating o,o'-dityrosine, as determined by mass spectroscopy in plasma, in terms of absolute concentrations and percentages of baseline, will be compared within and between treatment arm participants.

Secondary outcomes(4)
  1. Collagen Degradation Product by Enzyme Linked Immunoabsorbant Assay

    Time frame · Baseline to week 24

    Registry description

    Changes in concentrations of the collagen degradation product, serum C1M measured by enzyme linked immunsorbent assays will be compared between baseline values and those at 24 weeks, and between experimental arm and control participants.

  2. Pulmonary Function by Spirometry

    Time frame · Baseline to week 24

    Registry description

    Forced vital capacity (FVC), measured by spirometer at baseline, will be compared to values at the conclusion of the study and between the two treatment arms.

  3. Ambulatory Ability by Measuring Walk Distance in Six Minutes

    Time frame · Baseline to week 24

    Registry description

    Six-minute walk distance (6MWD) will be compared at baseline and as changes from baseline among experimental arm participants and control subjects

  4. Evaluation of Safety by Adverse Events

    Time frame · Up to week 24

    Registry description

    The number of participants who had adverse events will be compared between experimental arm participants and those in the control arm.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From baseline thru week 24

Surrogate Biomarker of Oxidative Stress by Mass Spectroscopy

GroupValue (micromole/M tyrosine)Spread
Placebo Oral Tablet-79.9255.5
GKT13783113.339.3
Secondary and other outcome results(4)
Secondary outcome· Baseline to week 24

Collagen Degradation Product by Enzyme Linked Immunoabsorbant Assay

GroupValue
GKT137831not posted
Placebo Oral Tabletnot posted
Secondary outcomeMean· Baseline to week 24

Pulmonary Function by Spirometry

GroupValue (Liters)Spread
GKT1378312.80.9
Placebo Oral Tablet2.70.8
Secondary outcomeMean· Baseline to week 24

Ambulatory Ability by Measuring Walk Distance in Six Minutes

GroupValue (feet)Spread
GKT1378311190440
Placebo Oral Tablet1191425
Secondary outcomeNumber· Up to week 24

Evaluation of Safety by Adverse Events

GroupValue (participants)
GKT13783119
Placebo Oral Tablet17

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
GKT137831GKT137831 will be administered orally, at a dose of 400 mg twice daily, for a total of 24 weeks. GKT137831: GKT137831 is a NOX enzyme inhibitor0 / 307 / 3019 / 30
Placebo Oral TabletIdentically-appearing placebo oral tablets will be administered orally, twice daily, for a total of 24 weeks. Placebo Oral Tablet: see Arm/Group description0 / 283 / 2817 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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