Clinical Trial: A Phase IIa Study of KHK4563
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd
Current Primary Outcome: 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. [ Time Frame: Immediately following the first administration of study drug through Study Week 52. ]
Original Primary Outcome: Asthma exacerbation
Current Secondary Outcome:
- Pulmonary function as assessed by Forced Expiratory Volume in 1 Second (FEV1) and Peak Expiratory flow (PEF) [ Time Frame: From first administration of study drug through Study Week 52. ]Pre-dose/pre-bronchodilator Forced Expiratory Volume in 1 Second ( FEV1 ) at the study centre, morning and evening peak expiratory flow (PEF)
- Asthma control as assessed by ASTHMA CONTROL QUESTIONNAIRE6(ACQ6) [ Time Frame: From first administration of study drug through Study Week 52. ]ASTHMA CONTROL QUESTIONNAIRE6(ACQ6)
- Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From first administration of study drug through Study Week 68. ]Adverse Events/Serious Adverse Events (AE/SAE) - Laboratory variables - ECG (Electrocardiogram) - Physical Examination
- Time Profiles of Serum Concentration [ Time Frame: From first administration of study drug through Study Week 68 ]Serum benralizumab concentration
- Immunogenicity by serum incidence rate of positive anti-drug antibody [ Time Frame: From first administration of study drug through Study Week 68 ]Anti-drug antibodies (ADA)
Original Secondary Outcome:
Information By: Kyowa Hakko Kirin Co., Ltd
Dates:
Date Received: August 7, 2011
Date Started: August 2011
Date Completion:
Last Updated: December 21, 2014
Last Verified: December 2014