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 ]
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