Psoriasis Vulgaris, Psoriatic Arthritis, Psoriatic Erythroderma, Pustular; Psoriasis, Palmaris Et Plantaris
Conditions
Brief summary
This study \[4827-005 (post market)\] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) 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). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.
Interventions
DRUGBrodalumab 210mg SC
210 mg, subcutaneous dosing, every 2 weeks
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has voluntarily signed the written informed consent form to participate in this study * Subject has completed the study 4827-005 (phase 3)
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/sub investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and types of adverse events and adverse reactions | 28 weeks |
| Anti-KHK4827 antibody | 28 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI 50, 75, 90, and 100 | 28 weeks | — |
| Static physician's global assessment (sPGA) of 0 (clear) or 1(almost clear) | 28 weeks | — |
| sPGA of 0 (clear) | 28 weeks | — |
| Change in body surface area involvement (BSA) of lesion | 28 weeks | — |
| Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study. | 28 weeks | — |
| American College of Rheumatology (ACR) 20 | 28 weeks | — |
| Pustular symptom score | 28 weeks | This score indicate the severity of generalized pustular psoriasis (GPP). The severity of GPP (0:none-3:severe) is classified as mild(1), moderateor(2) severe(3) based on a total score after rating skin symptoms (erythema, pustules and edema) and systemic inflammation accom-panied by certain laboratory findings (fever, white blood cellcount, and serum CRP and albumin levels). |
| Serum KHK4827 concentration | 28 weeks | — |
| Clinical Global Impression (CGI) | 28 weeks | — |
| Percent improvement in PASI | 28 weeks | — |
Countries
Japan
Outcome results
None listed