A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)

Exclusion Criteria

• •Active or chronic infection requiring treatment
• •Any evidence of central nervous system lupus (including but not limited to seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis)
• •Currently on renal dialysis or expected to require dialysis during study period
• •Previous kidney transplantation or planned transplantation during study period
• •History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before randomization. The following cancers are not exclusionary: basal cell or squamous cell skin cancer; carcinoma in situ of the cervix; carcinoma in situ of the breast; incidental histological finding of prostate cancer
• •Heart failure due to Systemic Lupus Erythematodes, or any other severe cardiovascular involvement with safety concerns according to investigator's judgment
• •Any other known autoimmune disease that would interfere with an accurate assessment of clinical symptoms of SLE/LN or put the participant at undue risk
• •Previously failed treatment with MMF or any form of mycophenolate-based induction therapy, based on the investigator's opinion
• •Use of complementary therapies, including Traditional Chinese Medicine, herbs, or procedure (eg, acupuncture) that can potentially interfere with the efficacy and safety of participants as assessed by the investigator
• •SARS-CoV-2 antigen-based positive test at screening. The test is required regardless of whether the participant has been vaccinated
• •Known hypersensitivity or contraindication to efgartigimod, any excipient of the IMP, or SoC medication used in the study
• •In the opinion of the investigator, current or history of (ie, within 12 months of randomization) alcohol, drug, or medication abuse
• •Pregnant or lactating females and those who intend to become pregnant during study participation
• •Any conditions or circumstances that in the opinion of the investigator may make the participant unsuitable for the study
• •The full list of criteria can be found in the protocol.