Clinical trial NCT01412736: A Phase IIa Study of KHK4563
Official title: A Phase IIa , Double-blind, Placebo-controlled Dose-ranging Study to Evaluate the Efficacy and Safety of KHK4563 in Adults With Uncontrolled, Suspected Eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncontrolled and Suspected Eosinophilic Asthma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 20 through 75 years at the time of Week -3 visit.
2. Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
3. Physician prescribed daily use of medium-dose or high-dose ICS plus LABA or any combination of sequential dosing of either medium-dose or high-dose ICS/LABA for at least 12 months prior to Week -3 visit. Dose must be stable for at least 30 days prior to Week -3 visit.
4. At least 2, but not more than 6, documented asthma exacerbations in the 12 months prior to Week -3 visit that required use of a systemic corticosteroid burst.

Exclusion Criteria

1. Any condition (eg, any eosinophilic lower respiratory disease other than asthma, Churg-Strauss syndrome, hypereosinophilic syndrome, eosinophilic bronchitis, eosinophilic pneumonia, chronic obstructive pulmonary disease (COPD), bronchiectasis or cystic fibrosis (CF)) that, in the opinion of the investigator or Medical Expert, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
2. Any clinically relevant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to Week -3 visit or during the screening period.

Primary outcomes:
measure: 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.
timeFrame: Immediately following the first administration of study drug through Study Week 52.
Secondary outcomes:
measure: Pulmonary function as assessed by Forced Expiratory Volume in 1 Second (FEV1) and Peak Expiratory flow (PEF)
timeFrame: From first administration of study drug through Study Week 52.
measure: Asthma control as assessed by ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
timeFrame: From first administration of study drug through Study Week 52.
measure: Number of participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: From first administration of study drug through Study Week 68.
measure: Time Profiles of Serum Concentration
timeFrame: From first administration of study drug through Study Week 68
measure: Immunogenicity by serum incidence rate of positive anti-drug antibody
timeFrame: From first administration of study drug through Study Week 68
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Toyota-shi
country: Japan
state: Aichi
city: Kamogawa-shi
country: Japan
state: Chiba
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Ogaki-shi
country: Japan
state: Gifu
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Himeji-shi
country: Japan
state: Hyogo
city: Kobe-shi
country: Japan
state: Hyogo
city: Sagamihara-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Kishiwada-shi
country: Japan
state: Osaka
city: Koshigaya-shi
country: Japan
state: Saitama
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Itabashi-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Mizunami-shi
country: Japan
city: Osakasayama-shi
country: Japan
city: Oura-gun
country: Japan
city: Seto-shi
country: Japan
city: Chungcheongbuk-do
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyenggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon-si
country: Korea, Republic of
Study officials:
References: