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Clinical Trials List

Protocol NumberINS-416
NCT Number(ClinicalTrials.gov Identfier)NCT04677569
Active

2021-02-01 - 2026-06-22

Phase III

Not yet recruiting6

Recruiting2

Terminated4

ICD-10A31.0

Pulmonary mycobacterial infection

ICD-9031.0

Pulmonary diseases due to other mycobacteria

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)

  • Sponsor

    Insmed Incorporated

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
National Taiwan University Hospital Yunlin Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chih-Hsin Lee Division of Thoracic Medicine
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Susan Shin-Jung Lee Division of Infectious Disease
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林進國 Division of Thoracic Medicine
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jia-Yih Feng Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 劉家榮 Division of General Internal Medicine
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

  • 林振傑 Division of General Internal Medicine
  • 陳詩宇 Division of General Internal Medicine
  • 李孟叡 Division of General Internal Medicine
  • 張立禹 Division of General Internal Medicine
  • 柯政昌 Division of General Internal Medicine
  • JANN-YUAN WANG Division of General Internal Medicine
  • 耿立達 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chi-Li Chung Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 唐士恩 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

Objectives

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + Azithromycin + Ethambutol compared to the ELC (empty liposome control) + Azithromycin + Ethambutol on participant reported respiratory symptoms at Month 13.

Test Drug

Amikacin liposome inhalation suspension (ALIS)

Active Ingredient

Amikacin (Amikacin Sulfate)

Dosage Form

liposome inhalation suspension

Dosage

70 mg/mL

Endpoints

Primary Outcome Measures :

Change from Baseline in Respiratory Symptom Score at Month 13 [ Time Frame: Baseline to Month 13 ]

Inclution Criteria

Inclusion Criteria:

Male or female, ≥ 18 years of age (20 years or older in Japan).
Current diagnosis of Mybacterial avium Complex (MAC) lung infection. MAC or mixed infection with MAC as the dominant species allowed, with MAC as the intended organism for treatment.
A high-resolution chest computerized tomography (CT) scan or chest CT scan with contrast, read locally, within 6 months prior to Screening. Participants who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a high resolution chest CT scan or chest CT scan with contrast, read locally, during Screening.
Adherence to a predefined multidrug antimycobacterial regimen during the study.
Women of child bearing potential (WOCBP) agree to practice an acceptable method of birth control (eg, true abstinence [refraining from heterosexual intercourse during the entire study], copper intrauterine device IUD, hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill [combined with barrier method] or double barrier method plus a spermicidal agent, exclusive homosexual relationship, or sole male partner who has undergone surgical sterilization with confirmation of azoospermia at least 3 months post procedure) while participating in the study.
Provide signed informed consent prior to administration of study drug or performing any study related procedure.
Ability to comply with study drug use, study visits, and study procedures as defined by the protocol.

Exclusion Criteria

Exclusion Criteria:

Diagnosis of cystic fibrosis (CF).
History of more than 3 prior MAC lung infections.
Received any mycobacterial antibiotic treatment for current MAC lung infection.
Refractory MAC lung infection, defined as having positive MAC cultures while being treated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment, defined as negative sputum culture for MAC and cessation of treatment.
Relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤6 months of cessation of prior successful treatment.
Evidence of any pulmonary cavity ≥ 2 cm in diameter, as determined by chest CT scan, read locally, within 6 months prior to Screening.
Radiographic finding of new lobar consolidation, atelectasis, significant pleural effusion, or pneumothorax during routine clinical care within 2 months prior to Screening.
Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study.
Acute pulmonary exacerbation (eg, chronic obstructive pulmonary disease (COPD) or bronchiectasis) requiring treatment with antibiotics, or corticosteroids (intravenous [IV] or oral), within 4 weeks prior to and during Screening.
Current smoker.
History of lung transplantation.
Prior exposure to ALIS (including clinical study).
Known hypersensitivity to aminoglycosides.
Disseminated MAC infection.
Administration of any investigational drug within 8 weeks prior to Screening.
Acquired and primary immunodeficiency syndromes (eg, Human Immunodeficiency Virus (HIV)-positive, regardless of CD4 counts).
Current alcohol, medication, or illicit drug abuse.

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    400 participants

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