This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12
Time frame: 12 weeks
PASI 75 at Week 12
Time frame: 12 Weeks
PASI 50, 90 and 100 at Week 12
Time frame: 12 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12
Time frame: 12 Weeks
sPGA of "clear (0)" at Week 12
Time frame: 12 weeks
Body surface area involvement (BSA) of lesion at Week 12
Time frame: 12 weeks
American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12
Time frame: 12 weeks
Incidence and types of adverse events and adverse reactions
Time frame: 12 weeks
Profiles of Pharmacokinetics
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.