Psoriasis
Conditions
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.
Interventions
DRUGKHK4827
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| sPGA of clear (0) | 52 weeks | — |
| Body surface area involvement (BSA) of lesion | 52 weeks | — |
| Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) | 52 weeks | — |
| Profiles of pharmacokinetics | 52 weeks | Concentration of KHK4827 in serum |
| American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) | 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 | — |
Countries
Japan
Outcome results
None listed