JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus

Inclusion Criteria:

1. Subjects must have been diagnosed with systemic lupus erythematosus at least 24 weeksprior to screening and must be assessed to meet 2019 EULAR/ACR SLE classificationcriteria during screening.
2. the subject must meet one of the following at screening: a. ANA titer ≥1:80;b.anti-dsDNA antibody positive; c. Anti-Smith antibody positive.
3. At least one of the following SLE background standard therapies (including no morethan one immunosuppressant) was required for 12 weeks prior to randomization, and thedose must remain stable at least 30 days until randomization and throughout studyparticipation.

Exclusion Criteria:

1. Active lupus nephritis (defined as urinary protein >1g/24 h or urinary totalprotein/creatinine ratio (UPCR) >1 mg/mg (113 mg/mmol) within 8 weeks prior toscreening or at randomization).
2. Active lupus of the central nervous system (CNS) (including epilepsy, psychosis,organic encephalopathy syndrome, cerebrovascular accident, encephalitis, or CNSvasculitis) within 60 days prior to randomization.
3. Myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack,decompensated heart failure requiring hospitalization, grade III/IV heart failure, oruntreated severe sleep apnea occurred ≤6 months before screening.
4. Previous or current atrioventricular block of degree Ⅱ or Ⅲ, sick sinus syndrome,symptomatic bradycardia, atrial flutter or atrial fibrillation, ventricular arrhythmiaor syncope associated with heart disease, or other arrhythmia deemed clinicallysignificant and requiring intervention or treatment.
5. A history of severe respiratory disease or interstitial pneumonia or pulmonaryfibrosis，which were found by the medical history or lung function test or chest CTexamination conducted during screening or within 3 months prior to screening;Orabnormal pulmonary function of medical significance: 1 second forced expiratory volume (FEV1) or forced vital capacity (FVC)<70% of the expected value, or FEV1 /FVC < 0.7.
6. Patients with significant abnormalities in liver, renal function and blood routineduring screening, including glutamate aminotransferase (ALT) or aspartateaminotransferase (AST) exceeding 2 times the upper limit of normal value;Serumcreatinine greater than 1.5 times the upper limit of normal;Hemoglobin <90g/L;Whiteblood cell count <2.5×109/L, platelet count (PLT) <75×109/L;Lymphocyte count <0.8×109/L;Abnormal results of other laboratory tests may affect the completion of thetest or interfere with the test results according to the investigator.
7. Use of cyclosporine, tacrolimus, pimelimus, and sirolimus within 1 month prior torandomization.
8. Use of thalidomide or lenalidomide within 2 months prior to randomization.
9. Rituximab, telitacicept, or leflunomide were used in the 6 months prior torandomization.
10. Use of Belliumab within 3 months prior to randomization.
11. Intravenous treatment with cyclophosphamide was received within 6 months prior torandomization or oral treatment with cyclophosphamide within 30 days prior to initialadministration.
12. History of type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus withHbA1c> 8%, or diabetic subjects with organ involvement (e.g. retinopathy or kidneydisease).