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A Phase 3 Clinical Study of KHK4827

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782924
First Posted: February 4, 2013
Last Update Posted: February 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  Purpose
This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.

Condition Intervention Phase
Psoriasis Drug: KHK4827 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: An Extension Study in Subjects With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Incidence and types of adverse events and adverse reactions [ Time Frame: 52 weeks ]
  • Laboratory values and vital signs [ Time Frame: 52 weeks ]
  • Development of anti-KHK4827 antibody [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: 52 weeks ]
  • A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response [ Time Frame: 52 weeks ]
  • Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" [ Time Frame: 52 weeks ]
  • sPGA of "clear (0)" [ Time Frame: 52 weeks ]
  • Body surface area involvement (BSA) of lesion [ Time Frame: 52 weeks ]
  • American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) [ Time Frame: 52 weeks ]
  • Profiles of pharmacokinetics [ Time Frame: 52 weeks ]
    Concentration of KHK4827 in serum


Enrollment: 145
Study Start Date: March 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KHK4827 140mg SC Drug: KHK4827
Experimental: KHK4827 210mg SC Drug: KHK4827

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has voluntarily signed the written informed consent form to participate in this study
  • Subject has completed the week 12 evaluation of Study 4827-002

Exclusion Criteria:

  • Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
  • Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782924


Locations
Japan
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan, 100-8185
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01782924     History of Changes
Other Study ID Numbers: 4827-003
First Submitted: January 27, 2013
First Posted: February 4, 2013
Last Update Posted: February 16, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases