Clinical Trial: A Phase 3 Clinical Study of KHK 4827

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Brief Summary: This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).

Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome:

  • Incidence and types of adverse events and adverse reactions [ Time Frame: 28 weeks ]
  • Anti-KHK4827 antibody [ Time Frame: 28 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study. [ Time Frame: 28 weeks ]
  • Percent improvement in PASI [ Time Frame: 28 Weeks ]
  • PASI 50, 75, 90, and 100 [ Time Frame: 28 Weeks ]
  • Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)" [ Time Frame: 28 Weeks ]
  • sPGA of "0 (clear) [ Time Frame: 28 weeks ]
  • Change in body surface area involvement (BSA) of lesion [ Time Frame: 28 weeks ]
  • Clinical Global Impression (CGI) [ Time Frame: 28 weeks ]
  • American College of Rheumatology (ACR) 20 [ Time Frame: 28 weeks ]
  • Pustular symptom score [ Time Frame: 28 weeks ]
  • Serum KHK4827 concentration [ Time Frame: 28 weeks ]


Original Secondary Outcome: Same as current

Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: January 30, 2014
Date Started: February 2014
Date Completion:
Last Updated: January 3, 2017
Last Verified: January 2017