Adult subjects with moderate to severe plaque psoriasis
Conditions
Interventions
Parallel arm 1:Subcutaneous injection 100mg QX004N Injection (Week0?Week4?Week12?Week20?Week28)
Subcutaneous injection 200mg QX004N Injection(Week36?Week44)
Parallel arm 2:Subcutaneous injection 200mg QX004N Injection(Week0?Week4?Week12?Week20?Week28)
Parallel arm 3:Subcutaneous injection 200mg QX004N Injection(Week0?Week4?Week16?Week28)
Parallel arm 4:Subcutaneous injection Placebo(Week0?Week4?Week12)/ 200mg QX004N Injection(Week16?Week20?Week28?Week36?Week44)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Volunteer as a subject and sign the informed consent form; 2.Aged 18 to 75 (inclusive) when signing the ICFs, male or female; 3.Have a diagnosis of plaque psoriasis with or without psoriatic arthritis for at least 6 months before the first administration of study drug; 4.Have a diagnosis of moderate to severe plaque psoriasis at both Screening and Baseline (IGA >= 3, PASI >= 12, and BSA >=10%); 5.Subjects agree to have no reproductive plan and voluntarily take effective contraceptive measures during the trial and within 6 months after receiving the last administration of study drug (see Appendix 5 for specific contraceptive measures); 6.Subjects with the ability of communicating well with the investigators and completing the study according to protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Have a diagnosis of guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis, or other diseases that affect the evaluation of study drug (skin lesions or other systemic autoimmune diseases, etc.); 2.Female subjects with positive pregnancy test or during lactation; 3.Subjects who have experienced severe drug or food allergic reactions in the past, and/or are allergic to the study drug or its ingredients; 4.Prior recipient of targeted IL-12/ IL-23 (e.g., Stelara), or IL-23 drugs; 5.The following drugs are being used at screening period or have been used during the following periods: (1)Received topical drug therapy which may affect the evaluation of psoriasis within 2 weeks before screening [including but not limited to glucocorticoids (subjects are allowed to topically use US Class 6-7 glucocorticoids, such as desonide and hydrocortisone, but limited to the face), calcineurin inhibitors (tacrolimus and pimecrolimus can be used on the face), tar preparations, tretinoins, vitamin D3 derivatives and compound preparations, etc.; (2)Treatment with oral traditional Chinese medicine therapies within 2 weeks, or treatment with topical traditional Chinese medicine therapies within 1 weeks before screening (if tripterygium wilfordii has been used to treat, subjects with the following conditions should be excluded: Treatment with systemic tripterygium wilfordii within 4 weeks, or treatment with topical tripterygium wilfordii within 2 weeks before screening); (3)Received Systemic drug therapy and/or any systemic immunosuppressant drug therapy which may affect the evaluation of psoriasis within 4 weeks before screening (including but not limited to methotrexate, cyclosporine, tretinoin, psoralen, sulfasalazine, azathioprine, Mycopheoclate Mofetil, hydroxyurea, anakinra, fumaric acid derivatives, or JAK inhibitors such as tofacitinib, baricitinib); (4)Use photochemical therapy (including psoralen plus ultraviolet A, PUVA) or phototherapy (including UVA, UVB) within 4 weeks before screening; (5)Received TNF-a antagonists within 3 months or five half-lives (whichever is longer) before screening (including but not limited to Adalimumab, Infliximab, Etanercept, Golimumab); received targeted IL-17 drugs (e.g., Ixekizumab) within 6 months prior to screening; received Natalizumab, Belimumab, or agents that modulate B cells or T cells (e.g., Rituximab) within 12 months prior to screening; 6.Evidence shows that subjects have severe progressive or uncontrolled cardiovascular disease, neuromuscular disease, hematological disease, respiratory disease, digestive disease, urinary disease, endocrine or metabolic disease, or neurological/psychiatric disease, and so on; 7.Opportunistic infections (recurrent severe herpes zoster, cytomegalovirus, pneumocystis carinii, histoplasmosis, Systemic candidiasis, aspergillus, nontuberculous mycobacteria, etc.) occurred within the 6 months before screening; 8.Have a history of recurrent or chronic infections, including but not limited to: chronic renal infections, chronic chest infections (such as bronchiectasis), symptomatic urinary tract infections, and open, drained, or skinned infected wounds. Have a history of severe infection (such as sepsis, pneumonia, pyelonephritis). Be in hospital or receive intravenous antibiotic treatment for infection within 2 months before screening; 9.Have malignant tumors or have a history of malignant tumors (except for skin squamous cell carcinoma, basal cel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving PASI90; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving PASI75;Proportion of subjects achieving PASI90;Proportion of subjects achieving PASI100;Proportion of subjects achieving IGA 0/1;Proportion of subjects achieving IGA 0;Change from baseline in BSA;Change from baseline in DLQI score;Safety and tolerability;Pharmacokinetic;Immunogenicity; | — |
Countries
China
Contacts
Public ContactZhang Jianzhong
Peking University People's Hospital
Outcome results
None listed