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.
HS-20137 is an antibody targeting IL-23, which were recommended biologic agents for the treatment of patients with moderate-to-severe psoriasis. This is a randomized, double-blinded, placebo-controlled phase 3 study, including a 4 weeks screening period, a 52 weeks double-blinded period (placebo-control period in the first 16 weeks) and a 8 weeks follow-up period (total 60 weeks). The hypothesis is that HS-20137 will be more effective in treatment of psoriasis than placebo and well tolerated. Participants with moderate-to-severe plaque psoriasis will be included in this study and received HS-20137 200mg or placebo in week 0, 4, 8 in placebo-control period and then HS-20137 200mg every 8 or 12 weeks thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
720
HS-20137 200mg injection at week 0, 4, 8 and then every 8 or 12 weeks.
Placebo 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
Time frame: 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)
Time frame: At week 16
PASI 90 response rate at other visit time points
Time frame: up to 60 weeks
PASI scores and changes from baseline at each visit time point
Time frame: up to 60 weeks
PASI 75 response rate and PASI 100 response rate at each visit time point
Time frame: up to 60 weeks
sPGA 0/1 response rate at other visit time points
Time frame: during the study period except 16 weeks
sPGA 0 response rate at each visit time point
Time frame: up to 60 weeks
BSA scores and changes from baseline at each visit time point
body surface area(BSA):0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease
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Time frame: up to 60 weeks