NCT03865927

GKT137831 in IPF Patients with Idiopathic Pulmonary Fibrosis

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients with Idiopathic Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
OTHER	Placebo Oral Tablet	see Arm/Group description
DRUG	GKT137831	GKT137831 is a NOX enzyme inhibitor

Timeline

• Start date: 2020-09-07
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2019-03-07
• Last updated: 2024-12-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study