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: January 6, 2014
Last verified: January 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
Asthma
Drug: KHK4563
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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:
  • Asthma exacerbation [ Designated as safety issue: No ]
    Observed number of asthma exacerbations


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 Drug: KHK4563
Multiple-dose subcutaneous administrations for 40 weeks every 4 weeks or every 8 weeks
Experimental: 20mg Drug: KHK4563
Multiple-dose subcutaneous administrations for 40 weeks every 4 weeks or every 8 weeks
Experimental: 100mg Drug: KHK4563
Multiple-dose subcutaneous administrations for 40 weeks every 4 weeks or every 8 weeks
Placebo Comparator: Placebo Drug: Placebo
Multiple-dose subcutaneous administrations for 40 weeks every 4 weeks or every 8 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uncontrolled asthma requiring medium-dose or high-dose ICS plus LABA
  • History of ≥ 2 but ≤ 6 documented asthma exacerbations in the 12 months that required use of a systemic corticosteroid burst
  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
Osaka, Japan
Korea, Republic of
Seoul, 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: January 6, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014