Moderate to severe plaque psoriasis
Conditions
Interventions
Group 1:The NVS451 fusion protein for injection or placebo 75 mg dose groups received subcutaneous injection at week 0, 2, and 4, respectively
Group 2:NVS451 fusion protein for injection placebo 75 mg/150 mg/ 225 mg/300 mg each dose group received subcutaneous injection at week 0, 2 and 4, respectively
Group 3:The NVS451 fusion protein for injection or placebo 225 mg dose groups received subcutaneous injection at week 0, 2, and 4, respectively
Group 4:The NVS451 fusion protein for injection or placebo 300 mg dose groups received subcutaneous injection at week 0, 2, and 4, respectively
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand and abide by the test process, voluntarily participate in the test and sign the informed consent; 2. When signing the informed consent, age = 18 years old =70 years old, gender is not limited; 3. The history of psoriasis =6 months at the time of screening was determined by the investigators to be stable plaque psoriasis and in the non-progressive stage; 4. Psoriasis subjects eligible for phototherapy or systemic treatment; 5. Body surface area (BSA) involved in plaque psoriasis = 10% at baseline;Psoriasis area and Severity index (PASI) score =12;The investigator's overall assessment is at least moderate or above (PGA=3); 6. Male and non-sterilized, premenopausal female subjects agree to use a medically recognized method of contraception or to use appropriate and effective contraception in accordance with regulations or guidelines.Medically accepted methods of contraception include, but are not limited to: condoms (male or female) with or without spermicide, spermicidal diaphragm or cervical cap, medically prescribed intrauterine devices (IUD), inert or copper containing IUD, hormone release IUD, systemic hormonal contraceptives, and surgical sterilization (such as hysterectomy or tubal ligation); 7. For fertile women, pregnancy test results are negative at the screening/baseline period.
Exclusion criteria
Exclusion criteria: 1. The presence of non-plaque psoriasis: guttate psoriasis, erythrodermic psoriasis, pustular psoriasis, drug-induced or drug-aggravated psoriasis; 2. Subjects who plan to require additional topical therapy, phototherapy, or other systemic therapy other than the investigational drug to treat psoriasis during the trial; 3. Any history of infection or recurrent infection requiring systemic antibiotic treatment within 2 weeks prior to screening, or serious infection requiring hospitalization or intravenous antibiotic treatment within 8 weeks prior to screening (e.g., pneumonia, cellulitis, bone or joint infection, etc.); 4. Known allergy to NVS451 fusion protein for injection or related excipients; 5. Pregnant or lactating women, female subjects or male subjects whose partners plan to become pregnant (during the study or within 6 months after the last administration of the study drug); 6. Positive anti-human immunodeficiency virus (HIV) antibody (HIV Ab) test results at screening, and/or positive for treponema pallidum specific antibodies;And/or hepatitis C virus antibody (HCV Ab) positive and positive by HCV RNA reverse transcription polymerase chain reaction test, indicating the presence of a past or current infection;And/or hepatitis B surface antigen (HbsAg) positive, or hepatitis B core antibody (HBcAb) positive and positive by HBV-DNA polymerase chain reaction test, indicating the present infection; 7. There is clinical evidence of active tuberculosis or suspected of active tuberculosis, or there is evidence of active tuberculosis in the past but has not received appropriate treatment or treatment records are missing;Or screening for evidence of latent tuberculosis infection; 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase >1.5× the upper limit of normal (ULN) during screening; 9. Serum creatinine >1.5× upper limit of normal (ULN), or creatinine clearance <60 mL/min; 10. Hemoglobin <10 g/dL (100 g/L) at screening time; 11. Absolute neutrophil count <1.5×109/L during screening; 12. Platelet count <100×109/L during screening; 13. Any other laboratory test abnormality that the investigator believes will prevent the subject from completing the study or interfere with the interpretation of the study results. 14. Prior or concurrent malignancies (excluding basal-cell carcinoma successfully treated, skin squamous cell carcinoma in situ, squamous cell carcinoma with no evidence of recurrence within 5 years, or adequately treated cervical carcinoma in situ); 15. Subjects who received live attenuated vaccine within 4 weeks prior to administration of the initial study drug, or who intend to receive live attenuated vaccine during the trial; 16. Participants who are currently participating in another interventional clinical trial or who participated in an interventional clinical trial within 4 weeks prior to the first investigational drug administration; Note: Participants participating in observational studies or non-interventional clinical studies may be included in this trial. 17. The subject is one of the persons directly involved in the study by the research center or the sponsor/designee; 18. During the 6 months prior to screening, any significant organ dysfunction or abnormalities in clinically significant laboratory testing present an unacceptable risk for participants to participate in an immunomodulatory therapy trial at the discretion of the investigator; 19. The presence of decompensated car
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability;Pharmacokinetic (PK) Characteristics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic (PD) index;Immunogenicity;Effectiveness index; | — |
Countries
China
Contacts
Public ContactDing Yangfeng
Shanghai Skin Disease Hospital
Outcome results
None listed