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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
145
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan
Incidence and types of adverse events and adverse reactions
Time frame: 52 weeks
Laboratory values and vital signs
Time frame: 52 weeks
Development of anti-KHK4827 antibody
Time frame: 52 weeks
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
Time frame: 52 weeks
A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response
Time frame: 52 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"
Time frame: 52 weeks
sPGA of "clear (0)"
Time frame: 52 weeks
Body surface area involvement (BSA) of lesion
Time frame: 52 weeks
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
Time frame: 52 weeks
Profiles of pharmacokinetics
Concentration of KHK4827 in serum
Time frame: 52 weeks
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