Safety and Efficacy of HPP737 in Adult Patients With Plaque Psoriasis

Inclusion criteria

• Subjects must voluntarily sign informed consent before any study-related procedures are initiated, be able to communicate effectively with the investigator, and be able to understand and comply with the requirements of this trial.
• Age at the time of signing the informed consent: 18 years ≤ age ≤ 70 years, regardless of gender.
• A documented history of chronic plaque psoriasis for ≥ 6 months.
• Moderate-to-severe plaque psoriasis meeting all of the following criteria: a) PASI (Psoriasis Area and Severity Index) score ≥12; and b) PGA (Physician's Global Assessment) score ≥3; and c) BSA (Body Surface Area) score ≥10%.
• Subjects are considered suitable for systemic therapy and/or phototherapy and/or photochemotherapy for psoriasis by the investigator.
• Body Mass Index (BMI): 18 kg/m2 ≤ BMI ≤ 35 kg/m2.

Exclusion criteria

• At screening, diagnosis of psoriasis is not chronic plaque-type psoriasis (e.g., pustular psoriasis, erythrodermic psoriasis, or guttate psoriasis).
• Patients with drug-induced psoriasis (triggered by medications such as β-blockers [beta-receptor blocking agents], calcium channel inhibitors [calcium channel blockers], or lithium) are included.
• Had a serious or systemic infection within 8 weeks before baseline that required intravenous anti-infective treatment or hospitalization due to infection.
• Presence of other dermatological conditions considered by the investigator to interfere with psoriasis assessment (e.g., skin bacterial, fungal, or viral infections; seborrheic dermatitis).
• History of inflammatory bowel disease or concurrent other active autoimmune diseases.
• History or symptoms of malignancy in any organ system within 5 years prior to screening, whether or not treated, and regardless of evidence of recurrence or metastasis.
• Subjects with a history of depression and/or who exhibit suicidal ideation or any suicidal behavior during the screening period and at baseline as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS, Posner K et al, 2011) will be excluded. If a subject answers "Yes" to any item on the C-SSRS questionnaire, or if the investigator clinically determines the subject to be at risk, the subject will be excluded from the study.
• Donation of blood or blood loss ≥400 mL within 8 weeks prior to baseline and/or planned blood donation during the study period.
• History of moderate-to-severe heart failure (New York Heart Association [NYHA] functional classification ≥Class 3), cardiovascular or cerebrovascular event, or other severe adverse events within 3 months prior to screening, and the investigator determines that such subjects are not suitable for participation in this clinical study.
• Any clinical condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial.
• Known allergy to any component or excipient of the investigational product, or hypersensitivity to other biological agents.
• Concomitant use of any of the following psoriasis treatments/medications: a) Tumor necrosis factor alpha (TNF-α) antagonist: ① Prior use of a single TNF-α antagonist (for example: use of adalimumab or infliximab within 60 days prior to baseline; use of golimumab within 90 days prior to baseline; use of etanercept within 28 days prior to baseline); ② or prior use of two or more TNF-α antagonists before screening. b) History of the use of other biologic agents prior to screening: including but not limited to anti-interleukin 17 (IL-17) agents, anti-IL-17 receptor agents, anti-IL-12/IL-23 class of drugs; c) Phototherapy/photochemotherapy (including psoralen plus ultraviolet A [PUVA] therapy, ultraviolet B [UVB], or systemic therapies [e.g., methotrexate, cyclosporine, cyclophosphamide, etc.]) within 4 weeks prior to baseline; d) Within 2 weeks prior to baseline, subjects received topical treatment for psoriasis, such as medium to high-potency corticosteroids, vitamin D3 derivatives, or retinoids; however, the following topical treatments are permitted: low-potency corticosteroids (potency classes 6-7), non-medicated shampoos (i.e., those not containing corticosteroids, vitamin D3 derivatives, calcineurin inhibitors, etc.), and emollients without α- or β-hydroxy acids. Received traditional Chinese medicine (TCM) therapy for psoriasis within 2 weeks before baseline.
• Use of oral or injectable glucocorticoids within 2 weeks before baseline.