Systemic lupus erythematosus
Conditions
Interventions
Study drug group:GR1603 injection
Placebo group:Placebo
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18-70 years old; 2. Weight >+ 40kg; 3. Diagnosed as SLE before randomization; 4. Antinuclear antibody positive (titer >= 1/80) and/or anti-double-stranded DNA antibody positive and/or anti-Sm antibody positive at screening; 5. Good compliance, the patient or his legal representative signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Active, severe lupus nephritis; 2. Have a history of lymphoproliferative diseases, or currently suffer from malignant tumors or have a history of malignant tumors (except for skin in situ squamous cell carcinoma, basal cell carcinoma and in situ cervical cancer that have undergone thorough treatment and have no signs of recurrence); 3. History of important organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation; 4. Past or current diagnosis of inflammatory joint or skin disease other than SLE disease, which may affect the assessment of disease activity; 5. Positive for hepatitis B surface antigen (HBsAg) at screening; positive for hepatitis B core antibody (HBcAb) and/or positive for hepatitis B e antigen (HBeAg) (except for those whose HBV DNA copy number is lower than the detection limit); hepatitis C virus antibody (HCV- Ab) positive; human immunodeficiency virus (HIV) antibody positive; anti-Treponema pallidum antibody (TP-Ab) positive (except RPR or TRUST negative); 6. Active tuberculosis at the time of screening, or latent tuberculosis at the time of screening (if appropriate treatment, can be enrolled); 7. Significant abnormalities in liver, kidney function and blood routine at screening, including: glutamate aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 2 times the upper limit of normal; serum creatinine greater than normal 1.5 times the upper limit of the value; hemoglobin 8% (only for diabetic patients); other laboratory test results are abnormal, which may affect subjects to complete the test or interfere with test results according to the investigators judgment; 8. Past or current severe herpes virus infection such as: herpes encephalitis, disseminated herpes, ocular herpes; within 1 year before signing the informed consent or current patients with severe anticardiolipin antibody syndrome (APS) (but for other Patients with severe APS who have been adequately controlled by aspirin or anticoagulants for at least 12 weeks can be enrolled); 9. Need oral anti-infective drugs (including anti-viral drugs) due to infection within 2 weeks before signing the informed consent; 10. Hospitalization or intravenous antibiotics for opportunistic infections within 3 years before randomization; 11. Have received live/attenuated vaccine within 8 weeks before signing the informed consent form or plan to receive live/attenuated vaccine during the trial; 12. Received intra-articular, intramuscular or intravenous glucocorticoids within 6 weeks before randomization; 13. Change the route of methotrexate administration (oral, SC or intramuscular injection) during the period from 8 weeks before randomization to the first day of administration; 14. After inquiries, it is known to be allergic to the investigational drugs (including excipients and similar drugs) or to suffer from severe allergic diseases or to be allergic (such as allergic to two or more drugs, food or pollen). compromise the safety of the subject; 15. Donated blood >= 400mL within 4 weeks before randomization, or had severe blood loss within 4 weeks before randomization and the blood loss was at least equivalent to 400mL, or received blood transfusion within 8 weeks, or planned to donate blood during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index, effectiveness evaluation index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters ;Transcription level of type I IFN gene in peripheral blood within 16 weeks; | — |
Countries
China
Contacts
Public ContactZhang Hao, Yang Guoping
the Third Xiangya Hospital of Central South University
Outcome results
None listed