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COMPLETED
NCT03865927
PHASE2

GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients With Idiopathic Pulmonary Fibrosis

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2020-09-07

Completion Date

2024-11-30

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

OTHER

Placebo Oral Tablet

see Arm/Group description

DRUG

GKT137831

GKT137831 is a NOX enzyme inhibitor

Locations (4)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Tulane University Medical Center

New Orleans, Louisiana, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Temple University Medical Center

Philadelphia, Pennsylvania, United States