Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

Inclusion criteria

• have had a detailed understanding of the nature, significance, potential benefits, potential risks, and procedures of the study, and voluntarily signed a written Informed Consent Form (ICF).
• Males or females aged≥18 and ≤75 years.
• Have a clinical diagnosis of SLE 6 months prior to signing the ICF, meeting at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
• SLEDAI-2K≥8 at screening.
• Are on a stable SLE SOC therapy consisting of any of the following medications for a period of at least 30 days prior to the first dose: glucocorticoid, and/or anti-malarials, and/or immunosuppressive agents.
• Have a positive test for anti-dsDNA antibody (> normal range) and/or anti-nuclear antibody (ANA) and/or anti-Smith antibody at screening.
• Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational agent. In this trial.

Exclusion criteria

Medical conditions:

• Pregnant or lactating women, and men or women who have birth plans in the past 12 months.
• Have neuropsychiatric systemic lupus erythematosus (NPSLE) within 6 months prior to the first dose, including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cranial neuropathy, cerebritis, cerebral vasculitis or lupus headache.
• Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.
• Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).
• Have a history of any non-SLE disease that has required treatment with oral or intravenous or intramuscular or subcutaneous injection glucocorticoids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
• Have a history of or current diagnosis of Central Nervous System (CNS) diseases.
• Have clinically documented cardiovascular diseases that are obviously unstable or not effectively treated.
• Have significant active lung diseases (e.g., interstitial lung disease, obstructive pulmonary disease).
• Have severe hepatobiliary diseases.
• Have a history of malignant neoplasm.
• Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
• Have known allergies to any component of the investigational agent as described in the Protocol.

Concomitant medication and surgery:

• Have received rituximab, epratuzumab, or any other B cell-depleting therapy within 12 months prior to randomization.
• Have received cyclophosphamide and chlorambucil within 6 months prior to randomization.
• Have received belimumab, tumor necrosis factor (TNF) blockers, interleukin receptor blockers or other biological agents within 3 months prior to randomization (or 5 half-lives, whichever is longer).

Lab tests:

• Have a positive test for human immunodeficiency virus (HIV) antibody.
• Have a positive test for Hepatitis B Surface Antigen (HBsAg) or hepatitis C antibody, or have a positive test for hepatitis B virus (HBV) DNA by Polymerase Chain Reaction (PCR) if positive for Hepatitis B Core Antibody (HBcAb).
• Have abnormal tissue or organ function, meeting any of the following at screening:

• Absolute neutrophil count (ANC) < 1.5 × 10^9/L; hemoglobin < 90 g/L; lymphocyte count < 0.8 × 10^9 /L.
• Calculated estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation < 45 mL/min/1.73 m2.

Others:

• Have other conditions that are not appropriate for participation in the trial as considered by the investigator.