A Study to Evaluate the Efficacy and Safety of HB0017 in Patients 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.

• Placebo (Other): Subjects will receive several injections of Placebo
• HB0017 (Drug), also known as HB0017 dosing regimens: Subjects will receive HB0017 in different dosing regimens

Primary outcomes

• PASI 90 response [Week 12]: Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
• sPGA 0/1 response [Week 12]: Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1

Secondary outcomes

• PASI 75 response [Week 12]: Proportion of subjects who achieve PASI 75 response or higher
• Adverse events [From baseline through 36 weeks]: Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)
• Immunity [From baseline through 36 weeks]: Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment
• PK characteristics [From Baseline through 36 weeks]: Population pharmacokinetics (PK), Apparent Total Clearance (CL/F)， Apparent Volume of Distribution (V/F) of HB0017
• PASI responses up to 36 Weeks [From Baseline through 36 weeks]: Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks
• sPGA 0/1 up to 36 Weeks [From Baseline through 36 weeks]: Proportion of subjects who achieve
• PD characterestics [From Baseline through 36 weeks]: HB0017 concentrations in serum at different time points
• PASI score change [From Baseline through 36 weeks]: change in PASI From Baseline to Week 36
• Percent change in PASI [From Baseline through 36 weeks]: Percent change in PASI From Baseline to Week 36

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* Subject has provided informed consent
* Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to Screening
* Psoriasis Area and Severity Index(PASI)>=12 and body surface area(BSA) >=10% and static Physician's Global Assessment (sPGA) score 3 or greater on a 5-point scale
* Candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy
* Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication

Key Exclusion Criteria:

* Forms of psoriasis other than chronic plaque psoriasis.
* History or evidence of active tuberculosis, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
* Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
* History of a serious or systemic infection within 4 weeks before screening.
* History of malignancy of any organ system within the past 5 years.
* Inadequate washout period for prior drug therapy.
* Previous use of secukinumab, ixekizumab or any other drug that targets Interleukin 17( IL-17) or IL-17 receptor.
* Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.

• Jianzhong zhang, Principal investigator, Peking University People's Hospital