A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

Korábbi kezelés

• Receiving medications or therapy that are prohibited as concomitant medications.
• Previously participated in a clinical trial for brensocatib.
• Received any live attenuated vaccine within 4 weeks prior to the first administration of brensocatib.
• Suffering an exacerbation 4 weeks before Screening or during the Screening period.
• Participated in any other interventional clinical studies within 3 months before Screening Visit.
• History of alcohol or drug abuse within 6 months prior to the Screening Visit.

Más betegség

• A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator.
• Current smokers as defined per Centers for Disease Control (CDC).
• Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections.
• Known history of human immunodeficiency virus (HIV) infection.
• Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis (TB).
• Active and current symptomatic infection by 2019 corona virus disease (COVID-19).
• Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).
• Known history of hypersensitivity to brensocatib or any of its excipients.

Egyéb

• Bronchiectasis due to cystic fibrosis.
• Adult participants only: Have compliance issues with completion of electronic diary entries during the Screening Period and in the opinion of the Investigator, compliance is unlikely to improve during the study.
• Is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.

• Provide their signed study informed consent to participate.
  • Adolescent participants must have signed study assent form to participate, and the adolescent's parent or legal guardian must have provided signed informed consent for the adolescent to participate.
• Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFBE) (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest computerized tomography (CT) scan.
• At least 2 PEs defined by need for antibiotic prescription by a physician for the signs and symptoms of respiratory infections in the past 12 months before the Screening Visit.
  • Adolescent participants are required to have at least 1 pulmonary exacerbation in the prior 12 months.
• Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (ie, methods that can achieve a failure rate <1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
• Male participants with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
• Male participants with pregnant or non-pregnant women of child-bearing potential partners must use condoms to avoid potential exposure to the embryo/fetus.