A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Specific dose of Tyk2 inhibitor on specific days
Specified dose of Placebo on specified days.
Shanghai Skin Disease Hospital
Shanghai, China
RECRUITINGThe Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12
Time frame: Baseline to Week 12
Percentage of Participants With PASI-90, PASI-100 on Week 12
Time frame: Baseline to Week 12
Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate)
Time frame: Baseline to Week 12
Change From Baseline in DLQI Scores to Week 12
Time frame: Baseline to Week 12
Change From Baseline in BSA to Week 12
Time frame: Baseline to Week 12
Number of Participants With Adverse Events
Time frame: From enrollment to Day 112
Mean steady-state plasma concentration of the drug (Cav,ss)
Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84
Steady-state trough plasma concentration of the drug (Ctrough, ss)
Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84
The area under the steady-state blood drug concentration-time curve (AUCss)
Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84
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