The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving clinical symptoms of CRSsNP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at Week 24
The computed tomography (CT) scan performed during Screening (considered as Baseline) and at Week 24 will be used for the volumetric assessment of maxillary and ethmoid sinus opacification.
Time frame: Baseline and Week 24
Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24
Time frame: Baseline and Week 24
Proportion of Participants Requiring Rescue (Antibiotics, Systemic Corticosteroids [SCS], and/or Nasal Surgery) due to Worsening of any Chronic Rhinosinusitis (CRS) Symptoms up to Week 24
Time frame: Baseline up to Week 24
Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24
Time frame: Baseline and Week 24
Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24
Time frame: Baseline and Week 24
Plasma Concentration of Brensocatib
Time frame: Pre-dose and at multiple timepoints post-dose up to Week 24
Percentage of Participants who Experienced at Least One Adverse Event (AE)
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Tucson, Arizona, United States
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Roseville, California, United States
USA006
Upland, California, United States
USA016
Boca Raton, Florida, United States
USA019
Hollywood, Florida, United States
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Miami, Florida, United States
USA009
Tampa, Florida, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
USA003
New Albany, Indiana, United States
...and 90 more locations
Determination of the safety and tolerability of brensocatib compared with placebo.
Time frame: Up to 28 weeks