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
  Purpose

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.


Condition Intervention Phase
Uncontrolled and Suspected Eosinophilic Asthma
Drug: KHK4563
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 106
Study Start Date: August 2011
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2mg
sterile lyophilized formulation, 2mg
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.
Experimental: 20mg
sterile lyophilized formulation, 20mg
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.
Experimental: 100mg
sterile lyophilized formulation, 100mg
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.
Placebo Comparator: Placebo
two SC administration on day 1
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412736

Locations
Japan
Nagoya-shi, Aichi, Japan
Toyota-shi, Aichi, Japan
Kamogawa-shi, Chiba, Japan
Fukuoka-shi, Fukuoka, Japan
Ogaki-shi, Gifu, Japan
Hiroshima-shi, Hiroshima, Japan
Sapporo-shi, Hokkaido, Japan
Himeji-shi, Hyogo, Japan
Kobe-shi, Hyogo, Japan
Sagamihara-shi, Kanagawa, Japan
Yokohama-shi, Kanagawa, Japan
Kumamoto-shi, Kumamoto, Japan
Kyoto-shi, Kyoto, Japan
Nagasaki-shi, Nagasaki, Japan
Kishiwada-shi, Osaka, Japan
Koshigaya-shi, Saitama, Japan
Shizuoka-shi, Shizuoka, Japan
Itabashi-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Mizunami-shi, Japan
Osakasayama-shi, Japan
Oura-gun, Japan
Seto-shi, Japan
Korea, Republic of
Chungcheongbuk-do, Korea, Republic of
Gwangju, Korea, Republic of
Gyenggi-do, Korea, Republic of
Seoul, Korea, Republic of
Suwon-si, Korea, Republic of
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01412736     History of Changes
Other Study ID Numbers: 4563-003
Study First Received: August 7, 2011
Last Updated: December 21, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration

Additional relevant MeSH terms:
Pulmonary Eosinophilia
Eosinophilia
Hematologic Diseases
Hypereosinophilic Syndrome
Leukocyte Disorders
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 26, 2015