Adult subjects with moderate to severe plaque psoriasis
Conditions
Interventions
QX001S injection treatment group:QX001S injection
Ustekinumab injection treatment group:Ustekinumab injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Volunteer to participance the study and sign informed consent form; 2.Male or female patients aged 18-75 years (inclusive); 3.Have a diagnosis of chronic moderate to severe plaque psoriasis at least 6 months before the first administration of study agent; 4.Chronic moderate to severe plaque psoriasis with Psoriasis Area and Severity Index (PASI) >=12 , Investigator Global Assessment (IGA) >=3 and involvement of Body Surface Area (BSA) >=10% at screening and before the first administration of study agent, and their condition was stable within two months before randomization; 5.Patients who are candidates for phototherapy or systemic treatment of psoriasis, after failed response to other topical therapy, and/or to phototherapy ,and/or to other systemic therapy; 6.Female patients of childbearing potential must have a negative pregnancy test at screening and before the first administration of study agent (D0); Female patients of childbearing potential and male patients who are sexually active must agree to use a barrier method of birth control during the study and within 15 weeks after receiving the last administration of study drug; 7.Female patients must agree to stop breastfeeding during the study period and within 15 weeks after the last dose; 8.Subject must be able to understand and communicate with the investigator and complete the study complying with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Weight > 100 kg; 2. Are using illicit drugs or have used illicit drugs within the following period: using topical anti-psoriatic drugs within 2 weeks before screening; using non-biological agents systemic treatment drugs (including but not limited to glucocorticoids) within 4 weeks before screening Hormones, leflunomide, methotrexate, cyclosporine, tretinoin, azathioprine, mycophenolate mofetil, Chinese medicine for the treatment of psoriasis and its preparations, etc.); use within 4 weeks before screening Photochemotherapy (such as psoralen combined with A-band ultraviolet exposure therapy [PUVA]) or phototherapy (such as long-wave ultraviolet [UVA], medium-wave ultraviolet [UVB]); use etanercept or its biological agents within 4 weeks before screening Similar drugs or application of tumor necrosis factor (TNF) inhibitors or their biosimilar drugs within 12 weeks before screening; or any other biological agents for the treatment of psoriasis within 5 half-lives; 3. Those who have used Useltuzumab or its biosimilar drugs or other IL-12/23 target drugs in the past, or who have used IL-23 target drugs in the past; 4. Those who have had or are suffering from malignant tumors in the past 5 years (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); 5. At the same time suffering from other active inflammatory diseases besides psoriasis that may confuse the evaluation of QX001S injection or Uselumumab injection. Patients suffering from underlying medical conditions (including but not limited to metabolism, hematology, kidneys, liver, lungs, nerves, , Endocrine, heart, infection or gastrointestinal tract). Currently suffering from a severely progressive or uncontrolled disease that is not suitable for the trial or puts it at high risk, including any medical or psychiatric conditions that the investigator believes will prevent the subject from following the protocol or completing the study according to the protocol; 6. The subject has moderate to severe congestive heart failure (New York Heart Association [NYHA] Grade III/IV) or uncontrolled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg); 7. Persons with a history of lymphoproliferative disease (including lymphoma or signs or symptoms of lymphoproliferative disease at any time); or splenomegaly; 8. Opportunistic infections (herpes zoster, cytomegalovirus, mycoplasma, pneumocystis carinii, histoplasmosis, candida, aspergillus, nontuberculous mycobacteria, etc.) occurred in the 6 months before screening; 9. A history of chronic or recurrent infectious diseases, or recent (within 6 months) serious or life-threatening infections (such as hepatitis, pneumonia, pyelonephritis, etc.), or any current symptoms or signs that may indicate infection (Such as fever, cough, urgency, dysuria, abdominal pain, diarrhea, skin infection wounds, etc.); 10. Subjects at high risk of infection (such as leg ulcers, indwelling catheters, persistent or recurrent chest infections, and long-term bedridden or sedentary wheelchair users); 11. Have received any major surgery within 8 weeks before screening, or will undergo major surgery during the study period, and the investigator believes that this will bring unacceptable risks to the patient; 12. Those who have been vaccinated with any live virus or live bacteria vaccine (such as Bacille Calmette Guer
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 index;Immunogenicity index;Pharmacokinetic index; | — |
Countries
China
Contacts
Public ContactZhang Jianzhong
People's Hospital of Peking University
Outcome results
None listed