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A Phase IIa Study of KHK4563 (4563-003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01412736
First received: August 7, 2011
Last updated: December 21, 2014
Last verified: December 2014

August 7, 2011
December 21, 2014
August 2011
July 2013   (final data collection date for primary outcome 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. [ Time Frame: Immediately following the first administration of study drug through Study Week 52. ] [ Designated as safety issue: No ]
annual asthma exacerbation rate
Asthma exacerbation [ Designated as safety issue: No ]
Observed number of asthma exacerbations
Complete list of historical versions of study NCT01412736 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Anti-drug antibodies (ADA)
Not Provided
Not Provided
Not Provided
 
A Phase IIa Study of KHK4563
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Uncontrolled and Suspected Eosinophilic Asthma
  • Drug: KHK4563
    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.
  • Drug: Placebo
    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.
  • Experimental: 2mg
    sterile lyophilized formulation, 2mg
    Intervention: Drug: KHK4563
  • Experimental: 20mg
    sterile lyophilized formulation, 20mg
    Intervention: Drug: KHK4563
  • Experimental: 100mg
    sterile lyophilized formulation, 100mg
    Intervention: Drug: KHK4563
  • Placebo Comparator: Placebo
    two SC administration on day 1
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
October 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of
 
NCT01412736
4563-003
No
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP