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

• Status: Recruiting
• Trial end date: 2023-08-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Amikacin; Azithromycin; Ethambutol

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:

• 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.