plaque psoriasis
Conditions
Interventions
Control group:Secukinumab 300mg i.c. W01234,then Q4W until W40.
Test group:SYS6012 300mg i.c. W01234,then Q4W until W40.
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged >=18 years. 2. Patients diagnosed with plaque psoriasis during the screening period, with a history of psoriasis =6 months before the first dose, with or without psoriatic arthritis. 3. Have moderate to severe plaque-type psoriasis as defined at screening and baseline by: a. PASI >=12; b. IGA >=3(based on a 0-4 scale); c. Body surface area(BSA)affected >=10%. 4. Candidates for phototherapy and systemic therapy. 5. Fertile female subjects must have a negative pregnancy test during the screening period and before the first dose,and both the subject and their partner must be willing to use highly effective contraceptive methods throughout the study period and for at least 20 weeks after the last dose of the study drug. 6. Must be willing to provide written consent and to comply with the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with non-plaque psoriasis (e.g., guttate, erythrodermic, pustular, or drug-induced psoriasis) during the screening period or prior to the first dose, or those with other skin conditions (e.g., eczema) that may interfere with the evaluation of the investigational drug's efficacy in psoriasis treatment. 2. Have a history or current diagnosis of other systemic autoimmune diseases that may affect the evaluation of efficacy and safety evaluations (e.g.,rheumatoid arthritis,systemic lupus erythematosus,scleroderma,inflammatory myopathy,mixed connective tissue disease,overlap syndrome,etc.). 3. Have previously received secukinumab, its biosimilar, or any drug that targets interleukin-17 or the IL-17 receptor. 4. Received ustekinumab,guselkumab,or other IL-23-targeting biologics within 6 months before the first dose. 5. Received any other systemic treatment with immunomodulatory biologics within 12 weeks or 5 half-lives of the drug(whichever is longer)before the first dose. 6. Received other investigational drugs(including investigational vaccines) or used invasive investigational medical devices within 4 weeks or 5 half-lives of other clinical trial drugs(whichever is longer) before the first dose, or are currently enrolled in an interventional investigative study. 7. Received topical treatment for psoriasis(e.g.,corticosteroids,vitamin D analogs,retinoids,salicylic acid,anthralin,etc.)within 2 weeks before the first dose. 8. Received long-wave ultraviolet A(PUVA)phototherapy(with or without oral psoralen),medium-wave ultraviolet B(UVB)phototherapy, systemic corticosteroids,glycyrrhizin,bupleurum,thunder god vine(or other herbs or traditional Chinese medicine with psoriasis treatment effects),or non-biologic drug treatment for psoriasis within 4 weeks before the first dose. 9. Have a history of allergy to the active ingredients or any excipients of the study drug or a history of latex allergy. 10. Received live virus or bacterial vaccines within 3 months before the first dose(or a longer period as specified in the vaccine instructions). 11. Active infection requiring hospitalization and/or intravenous anti-infective therapy within 8 weeks prior to the first dose of study treatment; active infection requiring oral anti-infective therapy within 2 weeks prior to the first dose of study treatment. 12. Subjects at high risk of infection(e.g.,leg ulcers,indwelling urinary catheters,persistent or recurrent chest infections,chronic obstructive pulmonary disease,chronic glomerulonephritis,long-term bedridden or wheelchair-bound). 13. Patients with a history of active TB, or screening subjects with active or latent TB infection. The exception for latent tuberculosis is: a) the patient has been confirmed by a specialist to have completed the relevant standard treatment for latent tuberculosis within 5 years prior to first dose of study treatment; Or b) the patient has received anti-TB prophylaxis at least 4 weeks prior to the first administration of the investigational drug and is willing to continue to complete prophylaxis according to local guidelines; Or c) the specialist judged that the risk of conversion to active tuberculosis was low and that treatment was not required. 14. A history of malignancy or lymphoproliferative disease within 5 years,except for cutaneous basal cell carcinoma treated with curative therapy or cervical carcinoma in situ that has been excised. 15. Received organ/tissue transplantation or stem cell trans
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Achieved >75 or Higher Psoriasis Area and Severity Index (PASI) Score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieve Investigator's Global Assessment (IGA mod 2011) ;Percentage change from baseline in PASI score ;Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI-50//90/100) ;Proportion of patients who achieve Investigator's Global Assessment (IGA mod 2011) ;Percentage change from baseline in BSA ; | — |
Countries
China
Contacts
Public ContactYuling Shi
Shanghai Skin Disease Hospital
Outcome results
None listed