Lupus Nephritis
Conditions
Keywords
Nephritis, Lupus Nephritis, Kidney Disease, Urologic Disease, Glomerulonephritis
Brief summary
The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN). The study comprises an approximate 4-week screening period, a 24-week treatment period, and an 8-week follow- up period.
Interventions
BIOLOGICALefgartigimod IV
Intravenous (IV) infusion of efgartigimod
OTHERPlacebo
Intravenous (IV) infusion of placebo
Sponsors
Zai Lab (Shanghai) Co., Ltd.
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 24 in urine protein creatinine ratio (UPCR) | up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete renal response (CRR) | up to 32 weeks | — |
| Proportion of participants achieving partial renal response at week 24 | up to 24 weeks | — |
| Time to partial renal response (PRR) | up to 24 weeks | — |
| Change from baseline to week 24 in estimated glomerular filtration rate (eGFR) | up to 24 weeks | — |
| Change from baseline to week 24 in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score | up to 24 weeks | — |
| Change from baseline to week 24 in the dosage of glucocorticoids | up to 24 weeks | — |
| Proportion of participants achieving complete renal response (CRR) at week 24 | up to 24 weeks | — |
| Proportion of participants achieving modified complete renal response (mCRR) at week 24 | up to 24 weeks | — |
| Efgartigimod serum concentration-time profile | up to 32 weeks | — |
| Changes from baseline in levels of total IgG | up to 32 weeks | — |
| Incidence of ADA against efgartigimod | up to 32 weeks | — |
| Median changes in concentration from baseline over time in biomarkers (Anti-dsDNA, C3, C4 and CH50) | up to 32 weeks | (all have the same measuring units) |
| Change from baseline to week 24 in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score | Up to 24 weeks | — |
| Treatment failure rate during treatment period | up to 24 weeks | — |
Countries
China
Outcome results
None listed