A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis
1 other identifier
interventional
73
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2023
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2022
CompletedStudy Start
First participant enrolled
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedDecember 18, 2025
October 1, 2025
2.4 years
December 19, 2022
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to week 24 in urine protein creatinine ratio (UPCR)
up to 24 weeks
Secondary Outcomes (14)
Proportion of participants achieving complete renal response (CRR) at week 24
up to 24 weeks
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
- +9 more secondary outcomes
Study Arms (2)
efgartigimod IV
EXPERIMENTALPatients receiving intravenous (IV) infusions of efgartigimod
Placebo
PLACEBO COMPARATORPatients receiving intravenous (IV) infusions of placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- argenxlead
- Zai Lab (Shanghai) Co., Ltd.collaborator
Study Sites (31)
Peking University Third Hospital
Beijing, 100191, 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
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huainan, China
Jieyang People's Hospital
Jieyang, 522091, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
Liu Zhou Works Hospital
Liuchow, China
Jiangxi Provincial People's Hospital
Nanchang, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Zhongda Hospital Southeast University
Nanjing, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Huashan Hospital Fudan University
Shanghai, China
ShengJing Hospital of China Medical University
Shenyang, China
Shenzhen People's Hospital
Shenzhen, China
The First Hospital of Hebei Medical University
Shijia Zhuang, China
The Second Hospital of Tianjin Medical University
Tianjin, China
Renmin Hospital of Wuhan University
Wuhan, China
Wuxi People's Hospital
Wuxi, China
Shaanxi Provincial Hospital of Chinese Medicine
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 310058, China
Henan Provincial People's Hospital
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2022
First Posted
April 13, 2023
Study Start
February 21, 2023
Primary Completion
July 2, 2025
Study Completion
September 1, 2025
Last Updated
December 18, 2025
Record last verified: 2025-10