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Liposomal Antibiotic

ALIS for Nontuberculous Mycobacterial Infections (ENCORE Trial)

Verified Trial

Phase 3

Recruiting

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 below

Exclusion 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 3 trial • 99 Patients • NCT04677543

42%

Dysphonia

27%

Cough

27%

Diarrhoea

13%

COVID-19

10%

Decreased appetite

10%

Haemoptysis

10%

Dyspnoea

10%

Oropharyngeal pain

10%

Headache

10%

Nausea

10%

Fatigue

Weight decreased

Sputum increased

Abdominal pain

Abdominal pain upper

Upper respiratory tract infection

Back pain

Wheezing

Rash

Dizziness

Tinnitus

Urinary tract infection

Asthenia

Squamous cell carcinoma of skin

Femoral neck fracture

Bronchiolitis

Acute coronary syndrome

Aphasia

Carotid artery stenosis

Drug hypersensitivity

100%

80%

60%

40%

20%

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