Efficacy and Safety of Telitacicept in Early SLE

Inclusion Criteria:

• 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 firstappearance 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

Exclusion Criteria:

• Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, andImmunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al
• Active serious neuropsychiatric systemic lupus erythematosus or other severesituations 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 CNSvasculitis) 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 oractive stage of pyelitis, recurrent pneumonia, chronic bronchiectasis andtuberculosis)
• Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV
• Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolicpressure > 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 beforerandomization
• Receipt of IVIG within 28 days before randomization
• Receipt of TNF inhibitor, IL-1R inhibitor or plasma exchange therapy within 90 daysbefore 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