This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Toyota-shi, Aichi-ken, Japan
evaluation of the effect of multiple-dose subcutaneous(SC) administration of benralizumab on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.
annual asthma exacerbation rate
Time frame: Immediately following the first administration of study drug through Study Week 52.
Pulmonary function as assessed by Forced Expiratory Volume in 1 Second (FEV1) and Peak Expiratory flow (PEF)
Pre-dose/pre-bronchodilator Forced Expiratory Volume in 1 Second ( FEV1 ) at the study centre, morning and evening peak expiratory flow (PEF)
Time frame: From first administration of study drug through Study Week 52.
Asthma control as assessed by ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
Time frame: From first administration of study drug through Study Week 52.
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Adverse Events/Serious Adverse Events (AE/SAE) - Laboratory variables - ECG (Electrocardiogram) - Physical Examination
Time frame: From first administration of study drug through Study Week 68.
Time Profiles of Serum Concentration
Serum benralizumab concentration
Time frame: From first administration of study drug through Study Week 68
Immunogenicity by serum incidence rate of positive anti-drug antibody
Anti-drug antibodies (ADA)
Time frame: From first administration of study drug through Study Week 68
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every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
Unnamed facility
Kamogawa-shi, Chiba, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Ogaki-shi, Gifu, Japan
Unnamed facility
Hiroshima, Hiroshima, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Himeji-shi, Hyōgo, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Sagamihara-shi, Kanagawa, Japan
...and 19 more locations