Last updated: October 18, 2021
Sponsor: Insmed
Overall Status: Active - Recruiting
Phase
3
Condition
Pulmonary Fibrosis
Treatment
N/AClinical Study ID
TX276502
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, ≥ 18 years of age (20 years or older in Japan)
- Clinical history consistent with non-cystic fibrosis bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest computerized tomography (CT) scan
- At least 2 pulmonary exacerbations 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
- Women must be post-menopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective double barrier contraception (i.e., methods that in combination achieve <1% unintended pregnancy rates per year) 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
Exclusion
Exclusion Criteria:
- A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator
- Bronchiectasis due to cystic fibrosis
- 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)
- Receiving medications or therapy that are prohibited as concomitant medications
- Suffering an exacerbation 4 weeks before Screening or during the Screening period
- History of alcohol or drug abuse within 6 months prior to the Screening Visit
Study Design
Study Start date:
June 28, 2021
Estimated Completion Date: