Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients With Treatment-refractory Mycobacterium Avium Complex Lung Disease
Sponsor: AN2 Therapeutics, Inc
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Phase 2: Assessment of novel Patient Reported Outcome instrument psychometric properties
Time frame: Screening (Day -14 to Day -7) to Month 6 + 1 week
Phase 2: Percentage of Participants Achieving Clinical Response
Time frame: Baseline to Month 6
Phase 2: Adverse Event Profile of 500 mg Once Daily Dose of Epetraborole
Time frame: Baseline to Month 16
Phase 3: Percentage of Participants Achieving Clinical Response
Time frame: Baseline to Month 6
Secondary Endpoints
Phase 2: Percentage of Participants Achieving Culture Conversion
Phase 2: Percentage of Participants Achieving Microbiological Improvement
Phase 2: Change from Baseline in QOL-B Respiratory Domain PRO
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients who are 18 years of age or older. 2. Willing and able to provide written informed consent. 3. Patients with a diagnosis of treatment-refractory MAC lung disease consisting of all of the following (a) Microbiological, (b) Clinical, and (c) Radiographic criteria: 1. Microbiological criteria: * One Pre-Study MAC-positive respiratory specimen. Documentation of a MAC positive specimen collected per standard of care within 6 months prior to signing the informed consent form (ICF). * One Screening MAC-positive expectorated or induced sputum sample. 2. Clinical criteria: At least 2 of the following patient-reported clinical symptoms: * Cough with sputum production * Cough without sputum * Chest congestion * Hemoptysis * Dyspnea * Fatigue * Night sweats or unusual sweating 3. Radiographic criteria: Non contrast Chest CT scan within 6 months prior to signing the ICF with abnormalitie…
Read full criteria on CT.gov →✦ Analyst Commentary
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