A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus

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• Main Inclusion Criteria:
• Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
• 5-17 years of age when signing the informed consent.
• Suject and/or legal guardian or parent provided written informed consent.
• SELENA SLEDAI score ≥ 8 at screening.
• Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening.
• Have been on a stable standard of care for SLE for at least 30 days prior to randomization.
• Female patients are required to be non-pregnant, non-lactating or sterile.
  • Main Exclusion Criteria:
• Have received Telitacicept at any time.
• Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals.
• Have received any of the following therapies within 90 days of baseline: anti-TNF or anti-IL-6 therapy, interleukin-1 receptor antagonist, intravenous immunoglobulin (IVIG), plasmapheresis.
• Have received any of the following therapies within 30 days of baseline: Intravenous cyclophosphamide, non-biological investigational agents (within 30 days of baseline or 5 half-lives, whichever is longer), newly added immunosuppressive/immunomodulatory agent, anti-malarial, NSAID, high-dose prednisone or equivalent (> 1.5 mg/kg/day) or any intramuscular or intravenous steroid.
• Have received live vaccine within 30 days of baseline.
• Participated in an interventional clinical trial within 6 months of screening.
• Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis.
• Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline.
• eGFR<30 mL/min/1.73m2.
• Acute severe nephritis.
• History of vital organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
• Significant unstable or uncontrolled acute or chronic diseases (cardiovascular, lung, hematology, gastrointestinal, liver, renal, neurologic, malignancy or infectious disease) that could be explained by causes other than SLE.
  • 13 Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.
• History of malignant neoplasm in the past 5 years. 15. Primary immune deficiency. 16. Acute or chronic infections requiring treatment. 17. HIV or HCV positive. 18. Tuberculosis. 19.HBsAg/HbcAb positive. 20.HBcAb positive. 21.History of COVID-19 within 4 weeks prior to screening. 22.History of hospitalization due to severe Covid-19 within 12 months prior to screening.
  • 23.History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
  • 24.History of drug or alcohol abuse or dependence within 364 days prior to baseline.
  • 25.Investigators believe that there are other factors that are not suitable for participating in the experiment.