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NADPH Oxidase Inhibitor

GKT137831 for Idiopathic Pulmonary Fibrosis (GKT137831 Trial)

Phase 2
Recruiting
Led By Steven R Duncan, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 40-85 years old
A diagnosis of IPF that fulfills current American Thoracic Society (ATS) Consensus Criteria
Must not have
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)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24

Summary

This trial is testing a new drug, GKT137831, to see if it can help treat idiopathic pulmonary fibrosis (IPF), a lung disease that until now has had no good treatment options. The drug works by inhibiting an enzyme that produces reactive oxygen species (ROS), which are thought to play a role in the development of IPF. If the drug is effective, it could represent a major breakthrough for IPF patients.

Who is the study for?
This trial is for adults aged 40-85 with Idiopathic Pulmonary Fibrosis (IPF) diagnosed within the last 5 years, meeting specific lung function criteria. Participants must be able to consent and follow study procedures. Excluded are those allergic to GKT137831, fertile women not using contraception, individuals with certain heart conditions or severe illnesses, recent users of high-dose steroids or immunosuppressants, cancer patients (with some exceptions), and anyone with major organ dysfunction.
What is being tested?
The trial tests GKT137831 against a placebo in IPF patients. This drug aims to reduce lung damage by inhibiting NOX enzymes that produce harmful reactive oxygen species involved in IPF development. The study's design involves randomly assigning participants to receive either the drug or a placebo tablet.
What are the potential side effects?
Potential side effects of GKT137831 aren't detailed here but may include reactions related to its action on NOX enzymes which could affect various body systems due to changes in oxidative stress levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 85 years old.
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I have been diagnosed with IPF according to the ATS guidelines.
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My IPF was diagnosed less than 5 years ago.
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I am between 40 and 85 years old.
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My condition meets the criteria for idiopathic pulmonary fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have untreated heart rhythm problems or a family history of long QT syndrome.
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I haven't taken high doses of steroids or immunosuppressants in the last month.
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I have a history of severe anemia or bone marrow disorders.
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I am on dialysis for end-stage kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mass Spectrometry
Secondary study objectives
Ambulatory ability by measuring walk distance in six minutes
Collagen degradation product by enzyme linked immunoabsorbant assay
Evaluation of safety by adverse events
+1 more

Side effects data

From 2019 Phase 2 trial • 111 Patients • NCT03226067
22%
Pruritis
17%
Nausea
11%
Headache
11%
Dizziness
8%
Constipation
8%
Abdominal Pain
8%
Fatigue
6%
Abdominal Pain Upper
6%
Upper Respiratory Tract Infection
6%
Urinary Tract Infection
6%
Oropharyngeal Pain
6%
Asthenia
6%
Pyrexia
6%
Diarrhea
6%
Abdominal Distension
3%
Nasopharyngitis
3%
Oral Herpes
3%
Arthralgia
3%
Multiple Fractures
3%
Gastrooesoghageal Reflux Disease
3%
Dry Mouth
3%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
GKT137831 400mg Twice Daily
Placebo Arm
GKT137831 400mg Once Daily

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GKT137831Experimental Treatment1 Intervention
GKT137831 will be administered orally, at a dose of 400 mg twice daily, for a total of 24 weeks.
Group II: Placebo Oral TabletPlacebo Group1 Intervention
Identically-appearing placebo oral tablets will be administered orally, twice daily, for a total of 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GKT137831
2017
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

Tulane UniversityOTHER
121 Previous Clinical Trials
239,040 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
58 Patients Enrolled for Idiopathic Pulmonary Fibrosis
University of MichiganOTHER
1,855 Previous Clinical Trials
6,435,001 Total Patients Enrolled
10 Trials studying Idiopathic Pulmonary Fibrosis
12,554 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Temple UniversityOTHER
315 Previous Clinical Trials
88,932 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
3,552 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

GKT137831 (NADPH Oxidase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03865927 — Phase 2
Idiopathic Pulmonary Fibrosis Research Study Groups: GKT137831, Placebo Oral Tablet
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: GKT137831 Highlights & Side Effects. Trial Name: NCT03865927 — Phase 2
GKT137831 (NADPH Oxidase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03865927 — Phase 2
~0 spots leftby Nov 2024
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