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

August 7, 2011
January 6, 2014
August 2011
July 2013   (final data collection date for primary outcome measure)
Asthma exacerbation [ Designated as safety issue: No ]
Observed number of asthma exacerbations
Same as current
Complete list of historical versions of study NCT01412736 on ClinicalTrials.gov Archive Site
Not Provided
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: KHK4563
    Multiple-dose subcutaneous administrations for 40 weeks every 4 weeks or every 8 weeks
  • Drug: Placebo
    Multiple-dose subcutaneous administrations for 40 weeks every 4 weeks or every 8 weeks
  • Experimental: 2mg
    Intervention: Drug: KHK4563
  • Experimental: 20mg
    Intervention: Drug: KHK4563
  • Experimental: 100mg
    Intervention: Drug: KHK4563
  • Placebo Comparator: Placebo
    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:

  • 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
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
Not Provided
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
January 2014

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