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Epetraborole for Mycobacterium Avium Complex Lung Disease
Phase 2 & 3
Waitlist Available
Research Sponsored by AN2 Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cough with sputum production
Cough without sputum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 16
Awards & highlights
Study Summary
This trial is testing a new potential treatment for MAC lung disease, which is difficult to treat. The trial will enroll patients who have not responded well to other treatments.
Who is the study for?
Adults with treatment-refractory MAC lung disease, who have persistent symptoms like coughing and fatigue despite previous treatments. They must show signs of the disease on a CT scan and have positive sputum samples for MAC. Participants should be able to survive with ongoing care, agree to birth control use, and commit to study requirements.Check my eligibility
What is being tested?
The trial is testing Epetraborole added to an optimized background regimen (OBR) against a placebo plus OBR in patients whose MAC lung disease hasn't improved with standard treatment. It's a critical Phase 2/3 study where participants are randomly assigned to either the drug or placebo group.See study design
What are the potential side effects?
While specific side effects of Epetraborole aren't listed here, common ones for new drugs can include nausea, diarrhea, liver issues like raised enzyme levels, potential heart rhythm problems (QT interval changes), allergic reactions or skin rashes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a cough that produces phlegm.
Select...
I have a dry cough.
Select...
I have chest congestion.
Select...
I have been coughing up blood.
Select...
I experience night sweats or unusual sweating.
Select...
My MAC lung disease has not improved with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to month 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 2: Adverse Event Profile of 500 mg Once Daily Dose of Epetraborole
Phase 2: Assessment of novel Patient Reported Outcome instrument psychometric properties
Phase 2: Percentage of Participants Achieving Clinical Response
+1 moreSecondary outcome measures
14. Phase 2: Area Under the Plasma Concentration-Time Curve from Time Point 0 Hours Until 24 hours [AUC(0-24)] post dose
Phase 2: Change from Baseline in NTM Symptoms Module PRO
Phase 2: Change from Baseline in QOL-B Respiratory Domain PRO
+20 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: epetraborole + OBRExperimental Treatment1 Intervention
epetraborole + Optimized Background Regimen
Group II: placebo + OBRPlacebo Group1 Intervention
Placebo + Optimized Background Regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epetraborole
2022
Completed Phase 1
~120
Find a Location
Who is running the clinical trial?
AN2 Therapeutics, IncLead Sponsor
4 Previous Clinical Trials
315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience shortness of breath.My MAC lung disease has not improved with treatment.My kidney function, measured by creatinine clearance, is 30 mL/min or less.My hemoglobin is above 10.0 g/dL, and I haven't donated blood or had significant blood loss recently.I have been coughing up blood.I often feel very tired.You have abnormalities in your chest CT scan that show a certain lung disease called MAC.You have tested positive for MAC (Mycobacterium avium complex) in a respiratory sample within the last 6 months.You have tested positive for MAC bacteria in a sputum sample during screening.I experience night sweats or unusual sweating.This criterion relates to specific rules about the presence of microorganisms, like bacteria or viruses.I have chest congestion.You are expected to survive and receive ongoing treatment for a specific type of infection during the entire study period, as determined by the doctor in charge.I experience at least two specific symptoms.I have a cough that produces phlegm.I have a dry cough.I have not had severe coughing up of blood recently.Your heart's electrical activity, called the QT interval, is too long based on a special heart test.I do not have severe liver problems, such as very high liver enzyme levels or signs of advanced liver disease.I have MAC lung disease that hasn't improved with treatment, confirmed by tests, symptoms, and scans.I have never taken epetraborole before.I don't have any health conditions that could affect the trial's outcome.I haven't had cancer treatments needing chemo or radiation within the last year.I am 18 years old or older.I have a weak immune system that could lead to lung infections.I plan to start a new TB treatment between now and the next 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: epetraborole + OBR
- Group 2: placebo + OBR
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.
How many test subjects are in this experiment?
"A total of 314 patients that meet the pre-determined inclusion criteria are needed for this study. These enrollees can come from different medical centres, such as Duke University in Durham, North carolina and Mount Sinai Roosevelt Hospital in New york City."
Answered by AI
Why was this clinical trial designed in this way?
"The main goal of this trial, which will be measured over a 6-month period, is to Phase 2: Adverse Event Profile of 500 mg Once Daily Dose of epetraborole. Additionally, the study will also focus on secondary outcomes like Phase 2: PK analysis of maximum plasma drug concentration [Cmax] and To evaluate the area under the concentration-time curve [AUC]) in epetraborole recipients in the PK Population. Lastly, researchers will also collect dataPhase 3: PK analysis of volume of distribution [Vd]."
Answered by AI
How many research centers are conducting this experiment?
"Currently, this clinical trial is running at 27 sites. These locations include Durham, New york and Cincinnati. To minimize the burden of travel, please select the clinic that is closest to your location."
Answered by AI
Are we still looking for participants in this clinical trial?
"This study is currently looking for candidates, as reported on clinicaltrials.gov. The clinical trial was originally posted on 5/20/2022 and was last edited on 11/10/2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
Ohio
What site did they apply to?
New York University Langone Medical Center
Southeastern Research Center
University of Cincinnati
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
What questions have other patients asked about this trial?
When and how long ? How often would I be seen?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
Because I'm on oxygen 24 7 with this illness. I would like future research to help with more insight on kidney disease.
PatientReceived no prior treatments
I’ve been on the 3 antibiotics for 8 years and still test positive- I am hoping this new trial will help!
PatientReceived 1 prior treatment
Was on three antibiotics for two years and still positive for NTM. I would like to like to be included in study.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- University of Cincinnati: < 48 hours
Average response time
- < 2 Days
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