The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 injection in patients with moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
SHR-1139 injection.
SHR-1139 injection placebo.
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Proportion of subjects with at least 90% improvement (PASI 90) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Time frame: At week 16.
Proportion of subjects with at least 75% improvement (PASI 75) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Time frame: At week 16.
Proportion of subjects with at least 100% improvement (PASI 100) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Time frame: At week 16.
Adverse events (AEs)
Time frame: Up to week 64.
Serum concentration of SHR-1139.
Time frame: Up to week 64.
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