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

Inclusion Criteria:

• Aged ≥18 years when signing the informed consent form (ICF)

• Capable of providing signed informed consent, and complying with protocolrequirements

• Diagnosis of SLE according to the Systemic Lupus Erythematosus InternationalCollaborating Clinic (SLICC) 2012 classification criteria

• Active, proliferative LN Class III or IV [excluding Class III (C), IV-S (C), andIV-G (C)], either with or without the presence of Class V using the 2003International Society of Nephrology (ISN)/Renal Pathology Society (RPS) criteria,proven by kidney biopsy within 6 months before randomization and confirmed by thecentral biopsy reading group

• Require LN induction therapy (glucocorticoids and MMF/MPA) based on investigator'sclinical judgment. Induction therapy may begin before screening but should beinitiated within 60 days before randomization

• Agree to use contraceptives consistent with local regulations. Full inclusioncriteria can be found in the protocol

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 CNSvasculitis)

• 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 ofrecurrence for ≥3 years before randomization. The following cancers are notexclusionary: basal cell or squamous cell skin cancer; carcinoma in situ of thecervix; carcinoma in situ of the breast; incidental histological finding of prostatecancer

• Heart failure due to Systemic Lupus Erythematodes, or any other severecardiovascular involvement with safety concerns according to investigator's judgment

• Any other known autoimmune disease that would interfere with an accurate assessmentof clinical symptoms of SLE/LN or put the participant at undue risk

• Previously failed treatment with MMF or any form of mycophenolate-based inductiontherapy, based on the investigator's opinion

• Use of complementary therapies, including Traditional Chinese Medicine, herbs, orprocedure (eg, acupuncture) that can potentially interfere with the efficacy andsafety of participants as assessed by the investigator

• SARS-CoV-2 antigen-based positive test at screening. The test is required regardlessof whether the participant has been vaccinated

• Known hypersensitivity or contraindication to efgartigimod, any excipient of theIMP, or SoC medication used in the study

• In the opinion of the investigator, current or history of (ie, within 12 months ofrandomization) alcohol, drug, or medication abuse

• Pregnant or lactating females and those who intend to become pregnant during studyparticipation

• Any conditions or circumstances that in the opinion of the investigator may make theparticipant unsuitable for the study

The full list of criteria can be found in the protocol.