A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
Lupus Nephritis
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring Nephritis, Lupus Nephritis, Kidney Disease, Urologic Disease, Glomerulonephritis
Eligibility Criteria
Inclusion Criteria: Aged ≥18 years when signing the informed consent form (ICF) Capable of providing signed informed consent, and complying with protocol requirements Diagnosis of SLE according to the Systemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 classification criteria Active, proliferative LN Class III or IV [excluding Class III (C), IV-S (C), and IV-G (C)], either with or without the presence of Class V using the 2003 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) criteria, proven by kidney biopsy within 6 months before randomization and confirmed by the central biopsy reading group Require LN induction therapy (glucocorticoids and MMF/MPA) based on investigator's clinical judgment. Induction therapy may begin before screening but should be initiated within 60 days before randomization Agree to use contraceptives consistent with local regulations. Full inclusion criteria 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 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. 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 Received live/live-attenuated vaccine within 28 days before randomization. The receipt of any inactivated, subunit, polysaccharide, or conjugate vaccine at any time before screening is not considered exclusionary. It is recommended that participants are up to date with vaccination(s) before the first dose of IMP Previously participated in a clinical study with efgartigimod 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
Sites / Locations
- Investigator site 1004Recruiting
- Investigator site 1061Recruiting
- Investigator site 1056Recruiting
- Investigator site 1054Recruiting
- Investigator site 1001Recruiting
- Investigator site 1010Recruiting
- Investigator site 1008Recruiting
- Investigator site 1012Recruiting
- Investigator site 1059Recruiting
- Investigator site 10046Recruiting
- Investigator site 1016Recruiting
- Investigator site 1017Recruiting
- Investigator site 1018Recruiting
- Investigator site 1019Recruiting
- Investigator site 1021Recruiting
- Investigator site 1028Recruiting
- Investigator site 1003Recruiting
- Investigator site 1031Recruiting
- Investigator site 1057Recruiting
- Investigator site 1034Recruiting
- Investigator site 1045Recruiting
- Investigator site 1036Recruiting
- Investigator site 1051Recruiting
- Investigator site 1025Recruiting
- Investigator site 1044Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
efgartigimod IV
Placebo
patients receiving infusions of efgartigimod
patients receiving infusions of placebo