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Liposomal Antibiotic
ALIS for Nontuberculous Mycobacterial Infections (ENCORE Trial)
Verified Trial
Phase 3
Waitlist Available
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You have not had a lung transplant.
You do not have a disease called cystic fibrosis.
Must not have
You need to be an adult and at least 18 years old (19 years in South Korea and 20 years in Japan).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial is testing if a new inhaler medication is better than the current one for treating a lung disease.
Who is the study for?
This trial is for adults with a lung infection caused by Mycobacterium Avium Complex (MAC) who haven't started treatment, haven't had a lung transplant, don't have cystic fibrosis, and have never taken ALIS before. Participants must be at least 18 years old, or the age of majority in their country.
What is being tested?
The study tests if inhaling ALIS (amikacin liposome inhalation suspension) combined with azithromycin and ethambutol improves respiratory symptoms after 13 months compared to an empty liposome control plus the same background regimen.
What are the potential side effects?
Possible side effects of ALIS may include coughing, wheezing or shortness of breath during inhalation; ringing in the ears; voice changes; and infections. Azithromycin and ethambutol can cause stomach upset, vision issues, and skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 3 trial • 99 Patients • NCT0467754342%
Dysphonia
27%
Cough
27%
Diarrhoea
13%
COVID-19
10%
Oropharyngeal pain
10%
Haemoptysis
10%
Decreased appetite
10%
Dyspnoea
10%
Headache
10%
Nausea
10%
Fatigue
8%
Weight decreased
8%
Sputum increased
8%
Abdominal pain
8%
Abdominal pain upper
6%
Upper respiratory tract infection
6%
Back pain
6%
Wheezing
6%
Rash
4%
Dizziness
4%
Tinnitus
4%
Urinary tract infection
4%
Asthenia
2%
Femoral neck fracture
2%
Squamous cell carcinoma of skin
2%
Bronchiolitis
2%
Acute coronary syndrome
2%
Aphasia
2%
Carotid artery stenosis
2%
Drug hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
ALIS + Background Regimen (Azithromycin + Ethambutol)
ELC + Background Regimen (Azithromycin + Ethambutol)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALIS + Background RegimenExperimental Treatment3 Interventions
Participants will be administered 590 mg of ALIS (amikacin liposome inhalation suspension) once daily. Participants will also be administered azithromycin 250 mg and ethambutol 15 mg/kg, once daily.
Group II: ELC + Background RegimenPlacebo Group3 Interventions
Participants will be administered ELC (empty liposome control), a visually matching placebo to ALIS (amikacin liposome inhalation suspension), once daily. Participants will also be administered azithromycin 250 mg and ETH (ethambutol) 15 mg/kg, once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALIS
2020
Completed Phase 3
~100
Azithromycin
2018
Completed Phase 4
~274950
Ethambutol
2023
Completed Phase 4
~3090
Find a Location
Who is running the clinical trial?
Insmed IncorporatedLead Sponsor
43 Previous Clinical Trials
7,156 Total Patients Enrolled