Adult subjects with moderate to severe plaque psoriasis
Conditions
Interventions
QX004N:150mg/ 300mg/ 600mg QX004N injection
Placebo:Placebo
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening. 4.Have a diagnosis of moderate to severe plaque-type psoriasis at Screening and at Baseline: IGA greater than or equal to (>=) 3, PASI >= 12, and involved body surface area (BSA) >=10 percent (%). 5. Subjects agree to have no reproductive plan and voluntarily take effective contraceptive measures during the trial and within 6 months after the trial (see Appendix 6 for specific contraceptive measures). 6. Subjects with the ability of communicating well with the researchers and completing the study according to protocol requirements.
Exclusion criteria
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. Prior recipient of targeted IL-12/ IL-23 (e.g., Stelara), IL-23 or IL-17 drugs. 3.Using prohibited drugs at screening or has used prohibited drugs during the following periods: - Received topical drug therapy which may affect the evaluation of psoriasis within 2 weeks before screening [including but not limited to corticosteroids (other than mometasone furoate for topical treatment), calcineurin inhibitors, tar preparations, tretinoin, vitamin D3 derivatives, capotriol, tazarostine, pimeclimus (for facial use), tachlimus (for facial use), and compound preparations, etc.]. - Received Systemic 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, or traditional Chinese medicines used for psoriasis). - 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). - Use photochemical therapy (including psoralen plus ultraviolet A, PUVA) or phototherapy (including UVA, UVB) within 4 weeks before screening. 4.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. 5. Opportunistic infections (recurrent severe herpes zoster, cytomegalovirus, mycoplasma, pneumocystis carinii, histoplasmosis, Systemic candidiasis, aspergillus, nontuberculous mycobacteria, etc.) occurred in the 6 months before screening (Note: The subject can be re-screened once when the infection has subsided). 6. Have a history of recurrent or chronic infections, including but not limited to: chronic kidney 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. 7. Have malignant tumors or have a history of malignant tumors (except for skin squamous cell carcinoma, basal cell carcinoma, and cervical carcinoma in situ that have been successfully treated and have no evidence of recurrence in 5 years). 8. Have or have had lymphoid hyperplastic disease, or symptoms or signs suggestive of lymphoid disease within 5 years before screening, or splenomegaly. 9. Subjects with a history of active tuberculosis, or those with active or latent tuberculosis infection during screening. 10. Subjects who received Live vaccine, live attenuated vaccine, inactivated vaccine, or adenovirus vector vaccine within 1 month before screening. 11. Subjects who received trial biologic therapy in 6 months before screening and the first-time study drug use, or those who received any trial treatment or study drug within 5 half-lives, or those who are in a clinical trial. 12. La
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving PASI75; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving PASI50, PASI75, PASI90, PASI100;Change from baseline in PASI score;Proportion of subjects achieving IGA 0/1;Change from baseline in BSA;Change from baseline in DLQI score;safety;immunogenicity;Pharmacokinetic; | — |
Countries
China
Contacts
Public ContactLi Shanshan
The First Hospital of Jilin University
Outcome results
None listed