This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
383
Eligible patients will receive ICP-488 orally as per the protocol
Eligible patients will receive ICP-488 Placebo orally as per the protocol
The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16
Time frame: week 16
Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16
Time frame: Week 16
Adverse events
Time frame: Week 52
Percentage of subjects with PASI 50/75/90/100 in each planned visit
Time frame: Week 52
Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits.
Time frame: Week 52
The proportion of subjects with sPGA score of 0 in each planned visit.
Time frame: Week 52
PK parameter: ICP-488 and its metabolite.
Time frame: Week 52
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