The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Korea, Republic of
Seoul, South Korea
Psoriasis area and severity index (PASI) 75 response
Time frame: at week 12
Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"
Time frame: at week 12
PASI 50/75/90/100 response by visit
Time frame: Baseline to week 64
sPGA of "0 (clear) or 1 (almost clear)" by visit
Time frame: Baseline to week 64
Body surface area (BSA) involvement of lesion
Time frame: Baseline to week 64
Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)
Time frame: Baseline to week 64
Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)
Time frame: Baseline to week 64
Dermatology life quality index (DLQI)
Time frame: Baseline to week 64
Treatment-emergent adverse events (TEAEs) or drug-related TEAEs
Time frame: Baseline to week 64
Laboratory values
Time frame: Baseline to week 64
Vital signs
Time frame: Baseline to week 64
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Anti-KHK4827 antibodies
Time frame: Baseline, Week 12, Week 24, Week 48, Week 64
Serum KHK4827 concentration
Time frame: Baseline, Week 8, Week 10, Week 12, Week 24