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NCT07301320 · ClinicalTrials.gov registry record · Phase 2
Epetraborole in Patients With Mycobacterium Abscessus Lung Disease
A Phase 2 study, sponsored by Kevin Winthrop.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT07301320: Recruiting Phase 2 study, sponsored by Kevin Winthrop.
NCT07301320 is a Phase 2 study that is actively recruiting participants, run by Kevin Winthrop. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07301320, a Phase 2 study, is actively recruiting participants, sponsored by Kevin Winthrop.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus complex (MABc) Lung Disease (LD) of mild to moderate severity. For this study, two EBO oral dose regimens will be studied in patients with MABc-LD, each compared to a placebo group (ie, 4 treatment groups): 500 mg daily and 750 mg daily. Detailed inclusion and exclusion criteria attempt to identify only those patients who have acceptable risks based upon the EBO preclinical findings, phase 1, phase 2, and Phase 3 experience; standard-of-care procedures; and the specified procedures of the study. Following receipt of informed consent, and a Screening period, eligible patients will be randomized to one of the 4 treatment groups to receive active or matched placebo EBO tablets for 84 days. Patients will be assessed for clinical and microbiological evidence of efficacy. At selected investigative sites, patients will undergo sparse PK sampling. Safety and tolerability will be determined by standard clinical and laboratory assessment, with oversight by a qualified and appropriately constituted Data Safety Monitoring Board (DSMB). Data collected during the study will be analyzed per a comprehensive Statistical Analysis Plan (SAP). The study will be registered on clinicaltrials.gov. The total duration of patient participation is approximately 6 months.
Primary Outcome
Improvement in severity of at least 50% of the symptoms present at baseline and no deterioration in severity of symptoms present at baseline
Interventions
- DRUG Placebo
- DRUG Epetraborole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2026-03-30 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
What NCT07301320 shows while recruiting
NCT07301320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07301320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07301320 about?
NCT07301320 is a clinical study titled "Epetraborole in Patients With Mycobacterium Abscessus Lung Disease". This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus complex (MABc) Lung Disease (LD) of mild to moderate severity. For this study...
What is the current status of trial NCT07301320?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2026-03-30. Estimated completion is 2028-05.
What interventions are being tested in trial NCT07301320?
The interventions under investigation include: Placebo (DRUG), Epetraborole (DRUG).
Who is sponsoring clinical trial NCT07301320?
This trial is sponsored by Kevin Winthrop, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07301320's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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