Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

• HB0017 Q4W (Biological): HB0017 at W0,1,2,4,8+HB0017Q4W
• HB0017 Q8W (Biological): HB0017 at W0,1,2,4,8+HB0017Q8W
• placebo (Biological): placebo at W0,1,2,4,8+HB0017Q4W

Primary outcomes

• Proportion of subjects achieving PASI 75 response at Week 12 [Week 12]: The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.
• Proportion of subjects achieving sPGA 0/1 response at Week 12 [Week 12]: The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1.

Secondary outcomes

• Proportion of subjects achieving PASI 90 response at Week 12 [Week 12]: The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline.
• PASI 90 response maintainance at week 52 [Week12-52]: Proportion of subjects maintaining PASI 90 response at Week 52 among those with PASI 90 response at Week 12
• sPGA 0/1 response maintainance at week 52 [Week 12-52]: Proportion of subjects maintaining sPGA 0/1 response at Week 52 among those with sPGA 0/1 response at Week 12.
• PASI 75 response maintainance at week 52 [Week12-52]: Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12.

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* Male or female subjects aged 18-75 years (inclusive)
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
* Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Static Physician Global Assessment (sPGA) score >=3.
* Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator
* Subjects who are able to use effective contraception from the screening period to 6 months after the last dose

Key Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline
* Drug-induced psoriasis
* Ongoing use of prohibited treatments
* Any active infection (other than common cold) within 14 days
* Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization
* Have previously received any drug that directly targets IL-17 or IL-17 receptor
* Have concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab and adalimumab <60 days; golimumab < 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs <6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization
* A history of inflammatory bowel disease or other serious autoimmune disease
* Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency

• Jianzhong Zhang, MD, Principal investigator, Peking University People's Hospital