Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

Official Title

ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

Keywords

Mycobacterium Infections, Nontuberculous, Nontuberculous Mycobacterial Lung Infection, Mycobacterium avium complex, Arikayce®, Infections, Communicable Diseases, Mycobacterium Infections, Mycobacterium avium-intracellulare Infection, Nontuberculous Mycobacterium Infections, Azithromycin, Amikacin, Ethambutol, ALIS

Eligibility

Locations

  • USA081
    San Francisco California 94143 United States
  • USA062
    Fresno California 93701 United States
  • USA050
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Insmed Incorporated
ID
NCT04677569
Phase
Phase 3 Nontuberculous Mycobacteria Research Study
Study Type
Interventional
Participants
About 425 people participating
Last Updated