The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
510
Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary.
Time frame: Baseline, Week 24
Mean CFBL in Endoscopic Nasal Polyp Score (NPS)
The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps.
Time frame: Baseline, Week 24
Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK)
Central read on sinus computed tomography (CT) scans for the Lund Mackay score (LMK) will be performed. Review of the CT scans of the right and left frontal sinuses will include the use of a scoring system. The LMK scoring system is a 3-point grading scale where 0 = normal, 1 = partial opacification, and 2 = total opacification. The total score is the sum of the scores from each side and ranges from 0 to 24, where 0 indicates no disease and 24 indicates the most severe disease.
Time frame: Baseline, Week 24
Mean change in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time frame: Baseline, Week 24
Mean CFBL in Severity of Loss of Smell
Participants will be asked about the severity of loss of smell using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of loss of smell, for the previous 24 hours. This assessment will be collected in the participant eDiary.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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AllerVie Clinical Research
Birmingham, Alabama, United States
NOT_YET_RECRUITINGUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGKeck Medicine of USC
Arcadia, California, United States
NOT_YET_RECRUITINGUniversity of California, Irvine
Irvine, California, United States
RECRUITINGDaVinci Research LLC
Roseville, California, United States
RECRUITINGBreathe Clear Institute
Torrance, California, United States
NOT_YET_RECRUITINGColorado ENT & Allergy
Colorado Springs, Colorado, United States
RECRUITINGOrlando ENT & Allergy
Orlando, Florida, United States
NOT_YET_RECRUITINGNuLine Clinical Trial Center
Pompano Beach, Florida, United States
NOT_YET_RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITING...and 183 more locations
Time frame: Baseline, Week 24
Mean CFBL in Postnasal Drip
Postnasal drip is rated by study participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours. This assessment will be collected in the participant eDiary.
Time frame: Baseline, Week 24
Mean Change from Baseline by Visit for the 22-item Sino-nasal Outcome Test (SNOT-22)
The 22-item Sino-nasal outcome test assessing sino-nasal and auricular function, psychological impact, productivity, and sleep quality. Participants will be asked to recall their experiences over the past 2 weeks and rate their symptoms on a scale ranging from 0, which corresponds to no problem, to 5, which corresponds to problem as bad as it can be.
Time frame: Baseline, Week 24
Mean Change from Baseline by Visit for the Nasal Peak Inspiratory Flow (NPIF)
NPIF measures the maximum inspiratory flow rate through both nostrils during inspiration with results expressed in liters per min (L/min). Participants with NPIF results \>120 L/min represent no nasal obstruction.
Time frame: Baseline, Week 24