The objective of this study is to evaluate the efficacy and safety of SC administrations of Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and immunogenicity will be assessed secondarily.
Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
Unnamed facility
Tokyo, Japan
The change from baseline in nasal polyp score at Week 12
Time frame: baseline and 12 weeks post-dose
The change from baseline in nasal polyp score
Time frame: Pre-dose and 4,8,12,16,20,24 weeks post-dose
The change from baseline in Computed tomography (CT) score
Time frame: baseline and 12 weeks post-dose
Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis
Time frame: Up to 24 weeks after dosing
Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis
Time frame: Up to 24 weeks after dosing
The change from baseline in Blood eosinophil count
Time frame: Pre-dose and 4,8,12,16,20,24 weeks post-dose
The change from baseline in Nasal Airway Resistance
Nasal airway resistance (Pa/cm\^3/s)
Time frame: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in the averaged values of the Olfactory thresholds
Olfactory thresholds are assessed by T\&T Olfactometer Test Score (Five kinds of smell with eight (5 to -2) phases).
Time frame: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in the improvement of olfactory dysfunction
Olfactory dysfunction (1 to 5) is calculated by the Olfactory thresholds.
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Time frame: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in Sino-Nasal Outcome Test-2 (SNOT-22)
Symptom score are assessed by VAS (nasal congestion, anterior and posterior nasal drip, loss of the sense of smell, headache, and impairment in activity of daily living)
Time frame: Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose
The change from baseline in Symptom score by Visual Analog Scale (VAS)
Symptom score are assessed by VAS (nasal congestion, anterior and posterior nasal drip, loss of the sense of smell, headache, and impairment in activity of daily living)
Time frame: Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Time frame: Up to 24 weeks after dosing