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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2mg | Experimental | sterile lyophilized formulation, 2mg |
|
| 20mg | Experimental | sterile lyophilized formulation, 20mg |
|
| 100mg | Experimental | sterile lyophilized formulation, 100mg |
|
| Placebo | Placebo Comparator | two SC administration on day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK4563 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately following the first administration of study drug through Study Week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From first administration of study drug through Study Week 52. |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
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| KHK4563 | Drug | 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. |
|
| KHK4563 | Drug | 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. |
|
| Placebo | Drug | 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. |
|
| Asthma control as assessed by ASTHMA CONTROL QUESTIONNAIRE6(ACQ6) |
ASTHMA CONTROL QUESTIONNAIRE6(ACQ6) |
| 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 | From first administration of study drug through Study Week 68. |
| Time Profiles of Serum Concentration | Serum benralizumab concentration | From first administration of study drug through Study Week 68 |
| Immunogenicity by serum incidence rate of positive anti-drug antibody | Anti-drug antibodies (ADA) | From first administration of study drug through Study Week 68 |
| Toyota-shi |
| Aichi-ken |
| Japan |
| Kamogawa-shi | Chiba | Japan |
| Fukuoka | Fukuoka | Japan |
| Ogaki-shi | Gifu | Japan |
| Hiroshima | Hiroshima | Japan |
| Sapporo | Hokkaido | Japan |
| Himeji-shi | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Sagamihara-shi | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Nagasaki | Nagasaki | Japan |
| Kishiwada-shi | Osaka | Japan |
| Koshigaya-shi | Saitama | Japan |
| Shizuoka | Shizuoka | Japan |
| Itabashi-ku | Tokyo | Japan |
| Shinagawa-ku | Tokyo | Japan |
| Shinjuku-ku | Tokyo | Japan |
| Mizunami-shi | Japan |
| Osakasayama-shi | Japan |
| Oura-gun | Japan |
| Seto-shi | Japan |
| Chungcheongbuk-do | South Korea |
| Gwangju | South Korea |
| Gyenggi-do | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |