Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07301320 | Epetraborole in Patients With Mycobacterium Abscessus Lung Disease | PHASE2 | RECRUITING | 84 | — | — | Mar 30, 2026 | May 1, 2028 | May 6, 2026 | 1 | United States |
Improvement in severity of at least 50% of the symptoms present at baseline and no deterioration in severity of symptoms present at baseline
Defined as 3 consecutive negative cultures one month apart without intervening or subsequent positives
Defined as improvement in sputum colony count category as defined by Griffith et al, 2015
QOL-B Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life
MACrO2 scores range from 0 to 100, with lower scores indicating better symptom-related quality of life
Defined as 2 consecutive negative cultures collected one month apart without intervening or subsequent positives
| Arm | Type | Description |
|---|---|---|
| High Dose Epetraborole | EXPERIMENTAL | This arm is a daily treatment regimen of a 750mg oral dose of Epetraborole. |
| Low Dose Epetraborole | EXPERIMENTAL | This arm is a daily treatment regimen of a 500mg oral dose of Epetraborole. |
| High Dose Placebo | PLACEBO_COMPARATOR | This arm is a daily treatment regimen of a placebo, matching the high dose experimental arm. |
| Low Dose Placebo | PLACEBO_COMPARATOR | This arm is a daily treatment regimen of a placebo, matching the low dose experimental arm. |
| Name | Type | Description |
|---|---|---|
| Epetraborole | DRUG | High-dose intervention (750mg daily) |
| Placebo | DRUG | Placebo intervention (matching the high-dose experimental intervention) |
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 MABc lung disease, meeting the following (a) Microbiological, (b) Clinical, (c) Radiographic a. Microbiological criteria: i. Documentation o...