Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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).

Official Title

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

Details

Keywords

MAC Lung Disease, Treatment Refractory MAC Lung Disease, NTM, Respiratory Infection, antimycobacterial activity, antimycobacterial agent, antimycobacterial therapy, MAC infections, MAC lung infection, MAC pulmonary infection, Mycobacteria, mycobacterial disease, mycobacterium, Mycobacterium Avium Complex, Mycobacterium Avium Complex Infections, Mycobacterium avium complex lung disease, Mycobacterium Infections, Nontuberculous, Nontuberculous mycobacteria / mycobacterial / mycobacterium, Non-tuberculous mycobacteria disease, Non-tuberculous mycobacterial (NTM) infections, Nontuberculous mycobacterial lung disease, Non-tuberculous mycobacterial lung disease, Nontuberculous mycobacterial pulmonary disease, NTM infection, NTM lung disease, NTM Pulmonary Disease, NTM lung infection, Pulmonary MAC disease, Pulmonary MAC lung disease, Pulmonary Mycobacterium Avium Complex disease, Treatment refractory mycobacterial lung disease, Treatment refractory NTM lung disease, Treatment refractory NTM lung infection, Treatment refractory NTM pulmonary disease, Mycobacterium avium-intracellulare Infection, Lung Diseases, Epetraborole, epetraborole + OBR

Eligibility

Locations

  • 423069
    San Francisco California 94143 United States
  • 423070
    Sacramento California 95817 United States
  • 423006
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AN2 Therapeutics, Inc
ID
NCT05327803
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 314 study participants
Last Updated