The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.
Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-week treatment Period, then a 4-week safety visit period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
HSK44459 dose level 1 oral administration
HSK44459 dose level 2 orally administration
placebo oral adminisitration
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Proportion of subjects who have ≥75% reduction in PASI (PASI-75).
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16.
Time frame: 16 weeks
Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline.
Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction at week 2, 4, 8, 12 and 16 from baseline.
Time frame: 2, 4, 8, 12 and 16 weeks
Proportion of subjects who have ≥75% reduction in PASI (PASI-75).
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 2, 4, 8 and 12.
Time frame: 2, 4, 8 and 12 weeks
Proportion of subjects who have ≥50% reduction in PASI (PASI-50).
The proportion of subjects who have a reduction of 50% or more from baseline in the psoriasis area-and-severity index score (PASI-50 at week 2, 4, 8, 12 and 16.
Time frame: 2, 4, 8, 12 and 16 weeks
Proportion of subjects who have ≥90% reduction in PASI (PASI-90).
The proportion of subjects who have a reduction of 90% or more from baseline in the psoriasis area-and-severity index score (PASI-90) at week 2, 4, 8, 12 and 16.
Time frame: 2, 4, 8, 12 and 16 weeks
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