Clinical Trial: An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis

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

Official Title: A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Brief Summary: This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.

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

Current Primary Outcome: Clinical Global Impression (CGI) [ Time Frame: 52 weeks ]

CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: 52 weeks ]
  • American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) [ Time Frame: 52 weeks ]
  • Pustular symptom score (only in subjects with pustular psoriasis) [ Time Frame: 52 weeks ]
  • Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma) [ Time Frame: 52 weeks ]
  • sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma) [ Time Frame: 52 weeks ]
  • Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma) [ Time Frame: 52 weeks ]
  • Incidence and types of adverse events and adverse reactions [ Time Frame: 52 weeks ]
  • Laboratory values and vital signs [ Time Frame: 52 weeks ]
  • Profiles of pharmacokinetics [ Time Frame: 52 weeks ]
    Concentration of KHK4827 in serum
  • Development of anti-KHK4827 antibody [ Time Frame: 52 weeks ]


Original Secondary Outcome: Same as current

Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: January 27, 2013
Date Started: February 2013
Date Completion:
Last Updated: February 12, 2015
Last Verified: February 2015