The purpose of this study is to evaluate the efficacy, safety, and tolerability of the study drug, brensocatib, as treatment for NCFBE. This is a double-blinded study.
The maximum study duration is 62 weeks total for an individual participant, including a Screening Period of up to 6 weeks, a Treatment Period of 52 weeks, and an End-of-Study Visit 4 weeks following the end of treatment. Approximately 1,620 subjects between the ages of 18 and 85 years, with diagnosed NCFBE are expected to participate in this study. The study is being conducted at approximately 480 centers in North America, Europe, Japan, and the rest of the world. All subjects will complete the same study procedures. The study will last approximately 62 weeks from the Screening (Visit 1) to the End of Study (Visit 12). There will be 12 visits including the Screening Visit (1 visit), Study Treatment Visits (10 visits: 6 visits are in the study clinic [Visits 2, 3, 5, 7, 9, and 11], and 4 visits by telephone from your home [Visits 4, 6, 8, and 10]), and an End of Study Visit (1 visit). The End of Study Visit (Visit 12) will occur in the study clinic.