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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights
GKT137831 Trial 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.Check my eligibility
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.See study design
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.
GKT137831 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 85 years old.
Select...
I have been diagnosed with IPF according to the ATS guidelines.
Select...
My IPF was diagnosed less than 5 years ago.
Select...
I am between 40 and 85 years old.
Select...
My condition meets the criteria for idiopathic pulmonary fibrosis.
GKT137831 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mass Spectrometry
Secondary outcome measures
Ambulatory ability by measuring walk distance in six minutes
Collagen degradation product by enzyme linked immunoabsorbant assay
Evaluation of safety by adverse events
+1 moreSide effects data
From 2019 Phase 2 trial • 111 Patients • NCT0322606722%
Pruritis
17%
Nausea
11%
Headache
11%
Dizziness
8%
Constipation
8%
Abdominal Pain
8%
Fatigue
6%
Abdominal Pain Upper
6%
Asthenia
6%
Oropharyngeal Pain
6%
Urinary Tract Infection
6%
Upper Respiratory Tract Infection
6%
Pyrexia
6%
Diarrhea
6%
Abdominal Distension
3%
Oral Herpes
3%
Nasopharyngitis
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
GKT137831 400mg Once Daily
Placebo Arm
GKT137831 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
115 Previous Clinical Trials
226,442 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
58 Patients Enrolled for Idiopathic Pulmonary Fibrosis
University of MichiganOTHER
1,797 Previous Clinical Trials
6,377,998 Total Patients Enrolled
10 Trials studying Idiopathic Pulmonary Fibrosis
12,554 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Temple UniversityOTHER
297 Previous Clinical Trials
82,913 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
3,552 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't needed antibiotics for an infection in the last 2 weeks.I don't have untreated heart rhythm problems or a family history of long QT syndrome.I am between 40 and 85 years old.My IPF was diagnosed less than 5 years ago.You are allergic to GKT137831 or any of the ingredients in the capsule.I am between 40 and 85 years old.I haven't taken high doses of steroids or immunosuppressants in the last month.I have been diagnosed with IPF according to the ATS guidelines.My IPF was diagnosed less than 5 years ago.You are able to give informed consent and are willing to follow study requirements.I have had cancer before, but not skin cancer or low-risk prostate cancer.You are being considered for a lung transplant or are on the waiting list for a lung transplant.I have not had a severe heart issue or stroke in the last 3 months.My condition meets the criteria for idiopathic pulmonary fibrosis.Your liver function tests show levels more than three times the normal range.I have a history of severe anemia or bone marrow disorders.Your lung function test shows that you can breathe out a certain amount of air.I am on dialysis for end-stage kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: GKT137831
- Group 2: Placebo Oral Tablet
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to enroll in this research endeavor?
"Individuals between the ages of 40 and 85 with usual interstitial pneumonia are eligible to partake in this clinical trial. Approximately 60 participants need to be enrolled into the study."
Answered by AI
Is the research project open to mature participants?
"For enrollment in this particular trial, a patient must be aged 40 to 85. Interestingly, there are 76 clinical trials for minors and 376 studies available for seniors above the age of 65."
Answered by AI
How many persons are participating in the research endeavor?
"Affirmative. Clinicaltrials.gov indicates that since its posting on September 7th 2020, this medical study has been actively recruiting participants. It is hoped to recruit 60 people from one single location."
Answered by AI
Is recruitment for this project still taking place?
"Clinicaltrials.gov reveals that recruitment is ongoing for this experiment, which was initially advertised on September 7th 2020 and most recently updated April 14th 2022."
Answered by AI
Has GKT137831 earned authorization from the Food and Drug Administration?
"The safety profile of GKT137831 has been evaluated by our team at Power and rated a 2; as this is a Phase 2 clinical trial, there are limited data points confirming its efficacy but numerous evidence suggesting the drug's security."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
University of Michigan Medical Center
Tulane University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Tulane University Medical Center: < 24 hours
Average response time
- < 1 Day
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