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 Mycobact (ENCORE)

  • STATUS
    Recruiting
  • End date
    Aug 21, 2023
  • participants needed
    250
  • sponsor
    Insmed Incorporated
Updated on 21 September 2022

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.

Details
Condition Mycobacterium Infections, Nontuberculous
Treatment ethambutol, Azithromycin, ALIS, ELC (matching placebo for ALIS)
Clinical Study IdentifierNCT04677569
SponsorInsmed Incorporated
Last Modified on21 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, ≥ 18 years of age (19 years or older in South Korea, 20 years or older in Japan)
Current diagnosis of MAC lung infection. MAC or mixed infection with MAC as the dominant species is allowed, with MAC as the intended organism for treatment
A chest computerized tomography (CT) scan, read locally, within 6 months prior to Screening to determine presence and size of pulmonary cavities. Participants who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a chest CT scan, read locally, during Screening
Willingness and ability to adhere to prescribed study treatment during the study
Women of childbearing potential (WOCBP) (ie, fertile following menarche and until becoming postmenopausal unless permanently sterile) and fertile men (ie, all men after puberty unless permanently sterile by bilateral orchidectomy) agree to practice a highly effective method of birth control from Day 1 to at least 90 days after the last dose. Examples of such birth controls are
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])
exclusive homosexual relationship, or
sole male partner who has undergone surgical sterilization with confirmation of azoospermia at least 3 months post procedure
Provide signed informed consent prior to administration of study drugs or performing
any study related procedure
Be able to comply with study drugs use, study visits, and study procedures as defined by the protocol
Men with partners who are WOCBP (pregnant or non-pregnant) agree to use condoms and non-pregnant partners should practice a highly effective method of birth control

Exclusion Criteria

Diagnosis of cystic fibrosis (CF)
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
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
History of more than 3 MAC lung infections
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
Relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤6 months of cessation of prior successful treatment
Prior exposure to ALIS (including clinical study)
Evidence of any pulmonary cavity ≥ 2 cm in diameter, as determined by chest CT scan, read locally, within 6 months prior to Screening
Disseminated MAC infection
Administration of any investigational drug within 8 weeks prior to Screening
Current alcohol, medication, or illicit drug abuse
Known hypersensitivity or contraindications to use to ALIS, aminoglycosides, or any of their excipients
Known or suspected acquired immunodeficiency syndromes (Human Immunodeficiency Virus (HIV) -positive, regardless of CD4 counts). Other immunodeficiency syndromes that may interfere with study participation in the opinion of the Investigator
Known and active COVID-19 infection
Known hypersensitivity or contraindications to use to ethambutol, azithromycin (including other macrolides or ketolides), or any of their excipients per local labeling guidance
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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