GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis (GKT137831)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03865927|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 20, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Other: Placebo Oral Tablet Drug: GKT137831||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Following screening assessments, IPF patients who meet all inclusion/exclusion criteria will be randomly assigned to receive one of the following treatments in a ratio of 1:1:
• Arm A (n=30) - GKT137831 Treatment:
GKT137831 will be administered orally, at a dose of 400 mg bid, for a total of 24 weeks.
• Arm B (n=30) - Placebo Treatment:
Arm B subjects will receive matching placebo for the same duration.
Participants will be followed in face-to-face visits with trial personnel every 6 weeks for 24 weeks to assess drug effects and monitor safety during their treatments, and by phone surveillances one month thereafter.
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients With Idiopathic Pulmonary Fibrosis|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||July 31, 2024|
GKT137831 will be administered orally, at a dose of 400 mg twice daily, for a total of 24 weeks.
GKT137831 is a NOX enzyme inhibitor
Placebo Comparator: Placebo Oral Tablet
Identically-appearing placebo oral tablets will be administered orally, twice daily, for a total of 24 weeks.
Other: Placebo Oral Tablet
see Arm/Group description
- Surrogate biomarker of oxidative stress by mass spectroscopy [ Time Frame: From baseline thru week 24 ]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.
- Collagen degradation product by enzyme linked immunoabsorbant assay [ Time Frame: Baseline to week 24 ]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.
- Pulmonary function by spirometry [ Time Frame: Baseline to week 24 ]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.
- Ambulatory ability by measuring walk distance in six minutes [ Time Frame: Baseline to week 24 ]Six-minute walk distance (6MWD) will be compared at baseline and as changes from baseline among experimental arm participants and control subjects
- Evaluation of safety by adverse events [ Time Frame: Baseline to week 24 ]The number and severity of adverse events will be compared between experimental arm participants and those in the control arm.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865927
|Contact: Steven R Duncan, MDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Steven R Duncan, MD||University of Alabama at Birmingham|