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A Phase IIa Study of KHK4563 (4563-003)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01412736
First received: August 7, 2011
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated 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
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: March 22, 2013
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 May 19, 2013