To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
209
To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis.
Placebo without drug substance.
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 at week 12
Achieve a PASI 75 ratio
Time frame: Up to week 12
Proportion of patients achieving Static Physician's Global Assessment (sPGA) 0/1 at week 12
It is used to observe the proportion of patients with 0 or 1
Time frame: Up to week 12
Proportion of patients achieving PASI 50 at week 12
Observed proportion of patients achieving PASI 50 at week 12
Time frame: Up to week 12
Proportion of patients achieving PASI 90 at week 12
Observed proportion of patients achieving PASI 90 at week 12
Time frame: Up to week 12
Proportion of patients achieving PASI 100 at week 12
Observed proportion of patients achieving PASI 100 at week 12
Time frame: Up to week 12
Body Surface Area (BSA) score
To observe the degree of change from baseline in BSA score at week 12
Time frame: Up to week 12
Dermatology Life Quality Index (DLQI) score
To observe the degree of change from baseline in DLQI score at week 12
Time frame: Up to week 12
Incidence of abnormal laboratory test markers
The proportion of patients with abnormal laboratory examination indicators, including blood routine and liver function, mainly includes blood routine, liver function, etc.
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The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The first affiliated hospital of chongqing medical university
Chongqing, Chongqing Municipality, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Liuzhou People'S Hospital
Liuchow, Guangxi, China
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
The Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital Of Xingtai Medical Colledge
Xingtai, Hebei, China
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
...and 25 more locations
Time frame: From randomization to 4 weeks after the last dose
Adverse event (AE)
Proportion of patients with adverse events, defined by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time frame: From randomization to 4 weeks after the last dose
Serious Adverse Events (SAEs)
Proportion of patients with serious adverse events, defined by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time frame: From randomization to 4 weeks after the last dose.
Tmax, ss
Refers to the time when the blood concentration reaches its peak after a single dose. At this point in time, the blood concentration is the highest.
Time frame: Within 1 hour before Day1, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day 15, Day 29, Day 57, Day 85 within 1 hour before administration, 1,1.5, 2, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours after Day 85
Cmax, ss
The steady-state concentration of the drug after multiple doses was investigated. Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72 hours after Day85.
Time frame: Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72 hours after Day85
Cmin, ss
The lowest concentration from the initial moment after administration to the lowest concentration before the next dose when multiple doses reach steady state. This index is a common indicator to reflect the level of drug accumulation, and is closely related to the drug dose, dosing interval and drug elimination rate.
Time frame: Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85
Area under the plasma concentration-time curve (AUC) 0-τ
When multiple administrations reach steady state, the area under the plasma concentration curve of each dosing interval is equal to the area under the plasma concentration curve from the time after administration to infinity.
Time frame: Within 1 hour before Day1 administration, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85
Rac
The ratio of the dose required to be given in one dose to the total dose required to be given in divided doses.
Time frame: Within 1 hour before Day1 administration, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85
Interleukin-17A (IL-17A) in serum
Change from baseline in serum IL-17A
Time frame: Within 1 hour before Day1 administration, Day15, Day29, Day85
Interleukin 19 (IL-19) in serum
Change from baseline in serum IL-19
Time frame: Within 1 hour before Day1 administration, Day15, Day29, Day85
β defensin in serum
Change from baseline in serum β defensin
Time frame: Within 1 hour before Day1 administration, Day15, Day29, Day85