This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
HB0017 at W0,1,2,4,8+HB0017Q4W
HB0017 at W0,1,2,4,8+HB0017Q8W
placebo at W0,1,2,4,8+HB0017Q4W
Proportion of subjects achieving PASI 75 response at Week 12
The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.
Time frame: Week 12
Proportion of subjects achieving sPGA 0/1 response at Week 12
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1.
Time frame: Week 12
Proportion of subjects achieving PASI 90 response at Week 12
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline.
Time frame: Week 12
PASI 90 response maintainance at week 52
Proportion of subjects maintaining PASI 90 response at Week 52 among those with PASI 90 response at Week 12
Time frame: Week12-52
sPGA 0/1 response maintainance at week 52
Proportion of subjects maintaining sPGA 0/1 response at Week 52 among those with sPGA 0/1 response at Week 12.
Time frame: Week 12-52
PASI 75 response maintainance at week 52
Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12.
Time frame: Week12-52
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