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Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease

NCT05327803 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2025-05-08

No results posted yet for this study

Summary

This is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. This study will enroll adult patients with treatment-refractory MAC lung disease who meet all eligibility criteria (including clinical, radiographic, and microbiological criteria).

Conditions

  • MAC Lung Disease
  • Treatment Refractory MAC Lung Disease

Interventions

DRUG

Epetraborole

500 mg taken orally QD

DRUG

Placebo

Placebo taken orally QD

Sponsors & Collaborators

  • AN2 Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2024-12-18
Completion
2024-12-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327803 on ClinicalTrials.gov