Epetraborole in Patients With Mycobacterium Abscessus Lung Disease

Conditions

• Mycobacterium Abscessus Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Epetraborole — DRUG
  High-dose intervention (750mg daily)
• Epetraborole — DRUG
  Low-dose intervention (500mg daily)
• Placebo — DRUG
  Placebo intervention (matching the high-dose experimental intervention)
• Placebo — DRUG
  Placebo intervention (matching the low-dose experimental intervention)

Study Details

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.

Key Dates

Start date

Mar 30, 2026

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

May 31, 2028

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: High Dose Epetraborole
  This arm is a daily treatment regimen of a 750mg oral dose of Epetraborole.
• Experimental: Low Dose Epetraborole
  This arm is a daily treatment regimen of a 500mg oral dose of Epetraborole.
• Placebo Comparator: High Dose Placebo
  This arm is a daily treatment regimen of a placebo, matching the high dose experimental arm.
• Placebo Comparator: Low Dose Placebo
  This arm is a daily treatment regimen of a placebo, matching the low dose experimental arm.

Primary Outcome Measure

Clinical Response (NTM Symptom Evaluation Instrument) at Day 84 [ Time Frame: Day 1 to Day 84 ]

Central Contacts

• Felicity Coulter, PhD
  503-494-2565
  [email protected]
• Brandy Peacock, DAOM, MAcOM
  (503) 494-8022
  [email protected]

Locations (1)

Find similar trials in Portland, OR