Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus

Exclusion Criteria

• •1. Subjects with severe lupus kidney disease (defined by proteinuria \>6g/24h or serum creatinine \>2.5mg/dL or serum creatinine \>221μmol/L) or active nephritis requiring prohibited medications, or subjects requiring hemodialysis or prednisone (or its equivalent)≥100mg/d for a period of ≥14 days within 8 weeks of Day 0;
• •2. Central nervous system (CNS) disease associated with lupus or not \[including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), encephalitis, CNS angiitis\] within 8 weeks prior to the screening visit;
• •3. Laboratory abnormalities including, but not limited to the following:
• •1. ALT/AST≥2×upper limit of normal (ULN);
• •2. endogenous creatinine clearance rate\<30 mL/min;
• •3. white blood cell count\<2.5×10\^9/L;
• •4. hemoglobin\<85 g/L;
• •5. platelet count\<50×10\^9/L;
• •4. Active hepatitis or a history of severe liver disease at the screening visit. Positive test for Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb). If anti-HBcAb result is positive while HBsAg result is negative, hepatitis B virus (HBV)-(DNA) test will be performed. If HBV-DNA result is negative, the patient is eligible;
• •5. Subjects with immunodeficiency, uncontrolled severe infection or active/recurrent gastrointestinal ulcers;
• •6. Pregnant or lactating female subjects or sexually active subjects who refuse to practice the protocol-specified contraception throughout the study;
• •7. History of allergy to humanized biological products;
• •8. Subjects who received live vaccine within 28 days of Day 0;
• •9. Participation in any other investigational study drug trial in the past 28 days or 5 half-lives, whichever was longer, prior to Day 0. Subjects who participated in a clinical trial on B-cell-targeted drug, or tumor necrosis factor inhibitor, or interleukin receptor blocker within 12 months prior to Day 0 would be excluded;
• •10. Subjects who received other B-cell targeted drugs, such as Belimumab, rituximab or Epratuzumab within 12 months prior to Day 0;
• •11. Subjects who received tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to Day 0;
• •12. Subjects who received intravenous immune globulin (IVIG), or high dose prednisone or its equivalents (≥100mg/d) for a period of ≥ 14 days, or plasma exchange within 28 days prior to Day 0;
• •13. Subjects who received IL-2, Thalidomide, Tripterygium wilfordii or Chinese medicinal preparations containing Tripterygium wilfordii within 28 days prior to Day 0;
• •14. Subjects with active infections (herpes zoster, HIV infection, active tuberculosis, etc.) at the screening visit;
• •15. Subjects with depression or suicidal thoughts;
• •16. Any condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol..