plaque psoriasis
Conditions
Interventions
Vunakizumab group:Vunakizumab treatment
Secukinumab group:Secukinumab treatment
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged >=18 years; 2.A history of plaque psoriasis for at least 6 months; 3.Diagnosis of moderate-to-severe plaque psoriasis at screening or prior to the first dose, defined by PASI >=12, sPGA >=3, and psoriasis involvement of body surface area (BSA) >=10%; 4.The patient voluntarily signs the informed consent form and is able to comply with the study requirements.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria shall be excluded from participation in this study: 1.Patients who have received topical treatments for psoriasis (e.g., corticosteroids, vitamin D analogs, retinoids, salicylic acid, anthralin, betamethasone, etc.) within 1 week prior to the first dose.Patients who have received long-wave ultraviolet (UVA) light therapy (with or without oral psoralen), medium-wave ultraviolet (UVB) light therapy, or any systemic conventional treatments for psoriasis, such as systemic corticosteroids, methotrexate, cyclosporine, acitretin, etc., within 4 weeks prior to the first dose.Patients who have received traditional Chinese medicine or herbal treatments for psoriasis, such as glycyrrhizin, total paeoniflorin, or tripterygium wilfordii, within 2 weeks prior to the first dose.Patients who have received oral small molecule inhibitors (e.g., apremilast with a half-life of 6-9 hours, deucravacitinib with a half-life of 10 hours) within 1 week prior to the first dose.Patients who have received any biologic therapy, except for IL-17 inhibitors, and have not completed a washout period of at least 4 half-lives (adalimumab half-life 14 days, etanercept half-life 3.5 days, infliximab half-life 10 days, ustekinumab half-life 21 days, guselkumab half-life 15-18 days) prior to the first dose; 2.Subjects with a history of prior use of IL-17A inhibitors(e.g., secukinumab, ixekizumab, bimekizumab, xeligekimab, or vunakizumab, etc.); 3.Subjects identified during screening as having non-plaque psoriasis (e.g., pustular psoriasis, erythrodermic psoriasis, guttate psoriasis, or drug-induced psoriasis, etc.), with the exception of psoriatic arthritis, will be excluded; 4.Presence of other skin conditions (e.g., skin infections, seborrheic dermatitis) that the investigator believes may interfere with the assessment of psoriasis; 5.History of inflammatory bowel disease or other ongoing active autoimmune diseases; 6.History of malignancy within the past 5 years (excluding previously treated basal cell carcinoma of the skin or surgically resected cervical carcinoma in situ; 7.Deemed by the investigator to have severe or uncontrolled cardiovascular, endocrine, or other systemic diseases that render the subject unsuitable for participation in the study; 8.Active infection during the screening period, or a history of requiring intravenous antibiotics and/or hospitalization for infection within <8 weeks prior to the first dose, or requiring oral antibiotics within <2 weeks prior to the first dose. Subjects with mild fungal infections may be allowed to participate in the study; 9.Evidence of positive antibody testing for infectious diseases such as hepatitis, syphilis, or HIV infection; 9.1 For subjects with syphilis infection, if the Treponema pallidum test is positive, further non-treponemal serological testing is required. If the result is negative, and the investigator determines that the subject had a past infection but has since recovered, they may meet the eligibility criteria for inclusion; 9.2 If HBsAg is positive, the subject will be excluded; If HBsAg is negative and anti-HBc is negative, the subject will not be excluded; If HBsAg is negative and anti-HBc is positive, further testing for HBV DNA is required. If HBV DNA is positive during screening, the subject will be excluded. If HBV DNA is negative during screening, the subject will not be excluded; 9.3 If anti-HCV is positive, circulating HCV RNA testing is required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time of PASI75; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median time of PASI50/90/100;Response rates of PASI 50, PASI 75, PASI 90, and PASI 100 at Week 12;Response rates of sPGA 0/1 and sPGA 0 at Week 12;Response rate achieving DLQI 0 or 1 at Week 12; | — |
Countries
China
Contacts
Public ContactGeng Songmei
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed