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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
138
210 mg, subcutaneous dosing, every 2 weeks
The Jikei University Scoole of Medicine
Tokyo, Japan
Incidence and types of adverse events and adverse reactions
Time frame: 28 weeks
Anti-KHK4827 antibody
Time frame: 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.
Time frame: 28 weeks
Percent improvement in PASI
Time frame: 28 weeks
PASI 50, 75, 90, and 100
Time frame: 28 weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
Time frame: 28 weeks
sPGA of "0 (clear)"
Time frame: 28 weeks
Change in body surface area involvement (BSA) of lesion
Time frame: 28 weeks
Clinical Global Impression (CGI)
Time frame: 28 weeks
American College of Rheumatology (ACR) 20
Time frame: 28 weeks
Pustular symptom score
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).
Time frame: 28 weeks
Serum KHK4827 concentration
Time frame: 28 weeks
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