NCT04677569

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mycobacterium Infections, Nontuberculous

Interventions

Type	Name	Description
DRUG	ALIS	Inhalation via nebulization over approximately 6 to 15 minutes
DRUG	Azithromycin	Oral tablet
DRUG	Ethambutol	Oral tablet
DRUG	ELC (matching placebo for ALIS)	Inhalation via nebulization over approximately 6 to 15 minutes

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-11-21
• Completion: 2026-01-15
• First posted: 2020-12-21
• Last updated: 2026-02-03

Locations

258 sites across 23 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, New Zealand, Poland, Portugal, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study