CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
GKT137831 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03865927
NCT03865927Phase 2Completed

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

University of Alabama at Birmingham·interventional·Posted Mar 7, 2019·Updated May 11, 2026

In Brief

A Phase 2 clinical trial evaluating Placebo Oral Tablet and GKT137831 for Idiopathic Pulmonary Fibrosis. Completed, enrolled 58 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 7, 2019
Enrollment StartSep 7, 2020
Primary CompletionNov 30, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.3 years ago

Interventions

Placebo Oral Tabletother

see Arm/Group description

GKT137831drug

GKT137831 is a NOX enzyme inhibitor