Moderate-to-severe Plaque Psoriasis
Conditions
Interventions
Group 2:Two doses of SHR-1139 injection and one dose of either SHR-1139 injection or placebo
Group 1:One dose of SHR-1139 injection, followed by one dose of placebo, followed by one dose of either SHR-1139 injection or placebo
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years at the time of signing the informed consent form, male or female; 2.Body mass index [BMI = weight (kg) / height^2 (m^2)] >=18 kg/m^2 at screening; 3.History of plaque psoriasis for >=6 months prior to randomization, with or without psoriatic arthritis; 4.Meeting all of the following criteria at both screening and baseline: PASI score >=12, and sPGA score >=3, and BSA >=10%; 5.Participants with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic psoriasis therapy; 6.Participants who voluntarily sign the informed consent form before any study-related procedures are initiated, are able to communicate well with the investigator, and understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study; 7.Female participants of childbearing potential or male participants whose partners are females of childbearing potential must have no plans for pregnancy, sperm/egg donation from the time of signing the informed consent form until 72 weeks after the last dose, and must voluntarily take effective contraceptive measures. Female participants must have a negative pregnancy test at screening and before randomization, and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of psoriasis other than chronic plaque psoriasis at screening or baseline (e.g., pustular psoriasis, erythrodermic psoriasis, and guttate psoriasis); 2.Drug-induced psoriasis (e.g., induced by beta-blockers, calcium channel inhibitors, or lithium); 3.Other skin problems that, in the investigator's opinion, would interfere with the assessment of psoriasis (e.g., skin infection, seborrheic dermatitis); 4.Concurrent other active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma or polymyositis, multiple sclerosis or other central demyelinating disorders, primary Sjögren's syndrome, etc.; 5.Use of the following biologics within the specified washout period prior to baseline: etanercept = III), cardiovascular or cerebrovascular events, or major bleeding events within 3 months prior to screening, which in the investigator's opinion would make the participant unsuitable for this study; 14.History of opportunistic infections (including but not limited to Pneumocystis carinii pneumonia, coccidioidomycosis, etc.) or immunodeficiencies within 6 months prior to screening; 15.Active infection requiring oral anti-infective treatment within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event;Dermatology Life Quality Index;Itch Numerical Rating Scale;sPGA response rate; | — |
Countries
China
Contacts
Public ContactBin Yang
Dematology Hospital of Southern Medical University
Outcome results
None listed