Efficacy and Safety of Telitacicept in Early SLE

- Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria

- 18-65 years of age

- body weight 45-90kg

- antinuclear antibody titers ≥1:80, and/ or anti-double-stranded DNA antibodies

- SLEDAI-2K score ≥8 scores

- Disease duration less than 2 years (defined as the duration between the first appearance of any symptom/sign attributed to SLE and baseline)

- A stantard therapy for at least 30d for patients who are not treatment-naive

- Negative pregnancy test for child-bearing women at screening and baseline

- Provide written informed consent

- Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al

- Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment

- severe lupus nephritis: 24hUP more than 6g, serum creatinine > 221umol/L

- History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1)

- Abnormal liver function (ALT or AST is 2 times higher than normal)

- Baseline IgG below the lower limit of the normal range

- Pregnancy or breastfeeding women

- Have a history of malignant tumors

- Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis)

- Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV

- Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics

- Active hemorrhage or peptic ulcer

- With other concommitant autoimmune disease;

- Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization

- Receipt of IVIG within 28 days before randomization

- Receipt of TNF inhibitor, IL-1R inhibitor or plasma exchange therapy within 90 days before randomization

- Participated in other drugs clinical trials within 4 weeks.

- Receipt of live vaccine within 4 weeks before randomization

- Receipt of COVID-19 vaccine within 4 weeks before randomization

- Subjects who in the opinion of the investigator are not suitable to participate