This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
251
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
AkesoBio Investigative Site 1011
Bengbu, Anhui, China
AkesoBio Investigative Site 1009
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1016
Beijing, Beijing Municipality, China
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Time frame: At week 12
Proportion of subjects who achieve PASI 75 response or higher at week 12
Time frame: At week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12
Time frame: At week 12
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks
Time frame: Baseline to week 68
AK111 concentrations in serum at different time points
Time frame: Baseline to week 68
Number and proportion of subjects who developed anti-drug antibodies (ADAs)
Time frame: Baseline to week 68
Change in serum IL-17A level (Pharmacodynamics parameter)
Time frame: Baseline to week 68
Adverse events (AEs)/serious adverse events (SAEs)
Time frame: Baseline to week 68
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AkesoBio Investigative Site 1003
Guangzhou, Guangdong, China
AkesoBio Investigative Site 1007
Guangzhou, Guangdong, China
AkesoBio Investigative Site 1012
Chengde, Hebei, China
AkesoBio Investigative Site 1018
Harbin, Heilongjiang, China
AkesoBio Investigative Site 1008
Changsha, Hunan, China
AkesoBio Investigative Site 1013
Yancheng, Jiangsu, China
AkesoBio Investigative Site 1001
Shanghai, Shanghai Municipality, China
...and 3 more locations