This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
161
Peking University People's Hospital
Beijing, China
Percentage of subjects with at least 75% improvement in PASI
Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment
Time frame: Day 1-Day 85
Percentage of subjects with at least 75% improvement in PASI
Percentage of subjects with at least 75% improvement in PASI from baseline at weeks 4 and 8 of treatment;
Time frame: Day 1-Day 56
Percentage of subjects with at least 90% improvement in PASI
Percentage of subjects with at least 90% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;
Time frame: Day 1-Day 85
Percentage of subjects with 100% improvement in PASI
Percentage of subjects with 100% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;
Time frame: Day 1-Day 85
Percentage improvement in PASI
Percentage improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;
Time frame: Day 1-Day 85
Percentage of subjects with a PGA
Percentage of subjects with a PGA score of 0 or 1 at weeks 4, 8, and 12 of treatment;
Time frame: Day 1-Day 85
The main PK parameters :Time to maximum measured plasma concentration(Tmax)
The main PK parameters :Time to maximum measured plasma concentration(Tmax)
Time frame: Day 1-Day 85
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The main PK parameters :Peak Plasma Concentration(Cmax)
The main PK parameters :Peak Plasma Concentration(Cmax)
Time frame: Day 1-Day 85
The main PK parameters:Area under the plasma concentration versus time curve(AUC)
The main PK parameters:Area under the plasma concentration versus time curve(AUC)
Time frame: Day 1-Day 85
The main PK parameters:Vz/F (apparent volume of distribution)
The main PK parameters:Vz/F (apparent volume of distribution)
Time frame: Day 1-Day 85
The main PK parameters: Half-life(t1/2)
The main PK parameters: Half-life(t1/2)
Time frame: Day 1-Day 85
The main PK parameters: Mean Residence Time (MRT)
The main PK parameters: Mean Residence Time (MRT)
Time frame: Day 1-Day 85
The main PK parameters:CL/F (apparent clearance)
The main PK parameters:CL/F (apparent clearance)
Time frame: Day 1-Day 85
Weight and height will be combined to report BMI in kg/m^2
Weight and height will be combined to report BMI in kg/m\^2
Time frame: Day -28-Day 99
Incidence and severity of AEs based on NCI CTCAE V5.0
Incidence and severity of AEs based on NCI CTCAE V5.0
Time frame: Day -28-Day 99
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Time frame: Day -28-Day 99