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.
Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).
Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.
Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.
Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and
Have received a dose of lebrikizumab.
Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period.
Allergen immunotherapy (subcutaneous immunotherapy [SCIT]/sublingual immunotherapy [SLIT]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).
Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.
Parallel
LY3650150
DrugAdministered SC.
Placebo
DrugAdministered SC.
Standard therapy for INCS
DrugAdministered as intranasal spray.
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.
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.
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.
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.
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.
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.
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