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. ]

annual asthma exacerbation rate


Original Primary Outcome: Asthma exacerbation

Observed number of asthma exacerbations


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