A Phase 3 Clinical Study of KHK4827
- Registration Number
- NCT01782924
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KHK4827 210mg SC KHK4827 - KHK4827 140mg SC KHK4827 -
- Primary Outcome Measures
Name Time Method Incidence and types of adverse events and adverse reactions 52 weeks Laboratory values and vital signs 52 weeks Development of anti-KHK4827 antibody 52 weeks
- Secondary Outcome Measures
Name Time Method Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) 52 weeks A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response 52 weeks Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" 52 weeks sPGA of "clear (0)" 52 weeks Body surface area involvement (BSA) of lesion 52 weeks American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) 52 weeks Profiles of pharmacokinetics 52 weeks Concentration of KHK4827 in serum
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
🇯🇵Chiyoda-ku, Tokyo, Japan