This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.
This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
452
Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.
Time frame: At week 16
Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).
Time frame: At week 16
Percentage of subjects who achieved at least 50% (PASI 50), 75% (PASI75, except week 16) and 90% (PASI 90) reduction in PASI score at each visit.
Time frame: Baseline to week 16
Percentage of subjects who achieved sPGA 0/1 at each visit.
Time frame: Baseline to week 16
Percentage change of PASI from baseline.
Time frame: Baseline to week 16
PK: AK101 serum concentration at different time points after administration.
Time frame: Baseline to week 16
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).
Time frame: Baseline to week 16
Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).
Time frame: Baseline to week 16
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AkesoBio Investigative Site 1010
Bengbu, Anhui, China
AkesoBio Investigative Site 1028
Hefei, Anhui, China
AkesoBio Investigative Site 1013
Wuhu, Anhui, China
AkesoBio Investigative Site 1001
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1027
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1034
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1035
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1036
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1049
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1051
Beijing, Beijing Municipality, China
...and 42 more locations