This study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of HB0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
RECRUITINGProportion of subjects achieving PASI 90 response
The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.
Time frame: Week 12
Proportion of subjects achieving sPGA 0/1
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 75 response
The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.
Time frame: Week 12
Proportion of subjects achieving PASI 100 response
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline
Time frame: Week 12
PASI 90 response maintainance at week 48
Proportion of subjects maintaining PASI 90 response at Week 48 among those with PASI 90 response at Week 12
Time frame: Week12-48
sPGA 0/1 response maintainance at week 48
Proportion of subjects maintaining sPGA 0/1 response at Week 48 among those with sPGA 0/1 response at Week 12.
Time frame: Week12-48
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RECRUITING...and 8 more locations