The primary objective of this study is to evaluate the efficacy and safety of HS-20137 in the treatment of participants with moderate to severe plaque psoriasis.
Adults aged 18 and above, male or female;
Diagnosed plaque psoriasis for at least 6 months before randomization, with or without psoriatic arthritis;
During screening and randomization, the severity of plaque psoriasis was moderate to severe, and the following conditions should be met: a) BSA≥10%; b) PASI≥12; c) sPGA≥3;
Suitable for systemic therapy or phototherapy;
Previous use of biological agents, or allergic reactions to known drug ingredients, or previous severe food or drug allergies;
Confirmation of other types of psoriasis, including but not limited to guttiform psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced exacerbation of psoriasis (including beta-blockers, non-steroidal anti-inflammatory drugs, antimalarial drugs, interferon, calcium channel blockers, or lithium induced psoriasis) from the screening period to the time before randomization;
Other skin lesions, chronic inflammatory diseases or autoimmune diseases, including but not limited to systemic lupus erythematosus, Sjogren's syndrome, skin sclerosis, etc., assessed by the investigator and other factors that may affect the efficacy evaluation or assessed by other researchers before randomization;
Primary treatment failure occurred with previous use of similar investigatory drugs (including marketed ulinumab, gusecciumab, Tiricizumab, Lisenciumab, and IL-23 target investigatory drugs under development) (the minimum treatment standard was not reached 12 weeks after the first treatment);
Parallel
HS-20137
DrugHS-20137 200mg injection at week 0, 4, 8 and then every 8 or 12 weeks.
Placebo&HS-20137
DrugPlacebo injection at week 0, 4, 8, and then HS-20137 200mg injection at week 16, 20, 24, and every 8 or 12 weeks thereafter
Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 90 Percent or Above
Number of participants achieving greater than or equal to 90 percent improvement in PASI at Week 16. PASI is a widely used tool for the measurement of severity of psoriasis. AND, number of participants achieving a physician global assessment (PGA) (0 \[none\] to 4 \[severe\]) of cleared or minimal at Week 16
Physician Global Assessment (PGA) score of 0/1
number of participants achieving a physician global assessment (PGA) (0 \[none\] to 4 \[severe\]) of cleared or minimal at Week 16. The PGA is 5-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 4 (severe)
PASI 90 response rate at other visit time points
PASI scores and changes from baseline at each visit time point
PASI 75 response rate and PASI 100 response rate at each visit time point
sPGA 0/1 response rate at other visit time points
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