This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
PASI 90 response
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Time frame: Week 12
sPGA 0/1 response
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1
Time frame: Week 12
PASI 75 response
Proportion of subjects who achieve PASI 75 response or higher
Time frame: Week 12
Adverse events
Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)
Time frame: From baseline through 36 weeks
Immunity
Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment
Time frame: From baseline through 36 weeks
PK characteristics
Population pharmacokinetics (PK), Apparent Total Clearance (CL/F), Apparent Volume of Distribution (V/F) of HB0017
Time frame: From Baseline through 36 weeks
PASI responses up to 36 Weeks
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks
Time frame: From Baseline through 36 weeks
sPGA 0/1 up to 36 Weeks
Proportion of subjects who achieve
Time frame: From Baseline through 36 weeks
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The first hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
...and 11 more locations
PD characterestics
HB0017 concentrations in serum at different time points
Time frame: From Baseline through 36 weeks
PASI score change
change in PASI From Baseline to Week 36
Time frame: From Baseline through 36 weeks
Percent change in PASI
Percent change in PASI From Baseline to Week 36
Time frame: From Baseline through 36 weeks