Status:
COMPLETED
A Phase IIa Study of KHK4563
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Uncontrolled and Suspected Eosinophilic Asthma
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 20 through 75 years at the time of Week -3 visit.
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- 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.
- 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
- 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.
- 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.
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to Week -3 visit or during the screening period.
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01412736
Start Date
August 1 2011
End Date
October 1 2013
Last Update
December 23 2014
Active Locations (29)
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1
Nagoya, Aichi-ken, Japan
2
Toyota-shi, Aichi-ken, Japan
3
Kamogawa-shi, Chiba, Japan
4
Fukuoka, Fukuoka, Japan