Abstract: FR-PO0826
Design of a Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Efgartigimod in Chinese Patients with Lupus Nephritis
Session Information
- Glomerular Clinical Trials: From Data to Impact
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Mariën, Lore, argenx, Ghent, Belgium
- Ye, Zhiming, Guangdong Provincial People's Hospital Guangdong Institute of Cardiovascular Diseases, Guangzhou, Guangdong, China
- Lu, Zekun, Zai Lab Ltd, Shanghai, China
- Liu, Yuansi, Zai Lab Ltd, Shanghai, China
- Liu, Jing, Zai Lab Ltd, Shanghai, China
- Shao, Jing, argenx, Ghent, Belgium
- Przekwas-Jaruchowska, Magdalena, argenx, Ghent, Belgium
- Nijs, Steven, argenx, Ghent, Belgium
- Hao, Chuan-Ming, Huashan Hospital, Fudan University, Division of Nephrology, Shanghai, China
- Zhao, Minghui, Peking University First Hospital Department of Nephrology Renal Division, Beijing, China
- Yu, Xueqing, Guangdong Provincial People's Hospital, Guangdong-Hong Kong Joint Laboratory on Immunological and Genetic Kidney Diseases, Guangzhou, China
Background
Lupus nephritis (LN) is an inflammatory autoimmune disease of the kidney caused by systemic lupus erythematosus (SLE). Pathogenic autoantibodies are hallmarks of SLE, particularly LN. Efgartigimod (EFG) is a human IgG1 antibody Fc fragment engineered for increased affinity to FcRn than endogenous IgG. EFG reduces FcRn-mediated recycling of IgGs resulting in increased IgG degradation. By reducing the level of pathogenic autoantibodies in circulation and glomeruli, EFG may slow disease progression in LN. We report on a proof-of-concept phase 2 study of EFG in Chinese participants (pts) with LN.
Methods
This multicenter, randomized, double-blinded, placebo-controlled study (NCT05810948) planned to enroll 72 Chinese pts who met eligibility criteria (Figure) during a ~4-week (wk) screening period. Pts were randomized 1:1 to receive weekly intravenous EFG or placebo as add-on to standard of care (SoC; glucocorticoids and mycophenolate mofetil/mycophenolic acid). After receiving treatment for 24 wks, pts switched to SoC only and were followed for 8 wks for safety monitoring. Randomization was stratified by LN renal biopsy class (class III/IV with or without V).
The primary endpoint is change from baseline to Wk 24 in urine protein creatinine ratio. Secondary endpoints include safety, proportion of pts achieving complete renal response (CRR) or partial renal response (PRR) at Wk 24, time to CRR and PRR, and change from baseline to Wk 24 in estimated glomerular filtration rate, SLE Disease Activity Index-2K score, and glucocorticoid dosage. Pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and quality of life will also be evaluated.
Results
Pt recruitment is complete. This ongoing study is expected to be completed in 2025.
Conclusion
This proof-of-concept study in LN assesses the efficacy and safety of EFG in Chinese pts.
Funding
- Commercial Support – argenx