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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
73
Intravenous (IV) infusion of efgartigimod
Intravenous (IV) infusion of placebo
Change from baseline to week 24 in urine protein creatinine ratio (UPCR)
Time frame: up to 24 weeks
Proportion of participants achieving complete renal response (CRR) at week 24
Time frame: up to 24 weeks
Time to complete renal response (CRR)
Time frame: up to 32 weeks
Proportion of participants achieving partial renal response at week 24
Time frame: up to 24 weeks
Time to partial renal response (PRR)
Time frame: up to 24 weeks
Change from baseline to week 24 in estimated glomerular filtration rate (eGFR)
Time frame: up to 24 weeks
Change from baseline to week 24 in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score
Time frame: up to 24 weeks
Change from baseline to week 24 in the dosage of glucocorticoids
Time frame: up to 24 weeks
Treatment failure rate during treatment period
Time frame: up to 24 weeks
Proportion of participants achieving modified complete renal response (mCRR) at week 24
Time frame: up to 24 weeks
Efgartigimod serum concentration-time profile
Time frame: up to 32 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peking University Third Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Hunan Provincial People's Hospital
Changsha, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Fujian Medical University Union Hospital
Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital,Sun Yat-sen University
Guanzhou, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
First Affiliated Hospital of University of South China
Hengyang, China
...and 21 more locations
Changes from baseline in levels of total IgG
Time frame: up to 32 weeks
Incidence of ADA against efgartigimod
Time frame: up to 32 weeks
Median changes in concentration from baseline over time in biomarkers (Anti-dsDNA, C3, C4 and CH50)
(all have the same measuring units)
Time frame: up to 32 weeks
Change from baseline to week 24 in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score
Time frame: Up to 24 weeks