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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan
Clinical Global Impression (CGI)
CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened
Time frame: 52 weeks
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
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Concentration of KHK4827 in serum
Time frame: 52 weeks
Development of anti-KHK4827 antibody
Time frame: 52 weeks