A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
NCT ID: NCT05810948
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2023-02-21
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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efgartigimod IV
Patients receiving intravenous (IV) infusions of efgartigimod
efgartigimod IV
Intravenous (IV) infusion of efgartigimod
Placebo
Patients receiving intravenous (IV) infusions of placebo
Placebo
Intravenous (IV) infusion of placebo
Interventions
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efgartigimod IV
Intravenous (IV) infusion of efgartigimod
Placebo
Intravenous (IV) infusion of placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
argenx
INDUSTRY
Responsible Party
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Locations
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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
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huainan, , China
Jieyang People's Hospital
Jieyang, , 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, , 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, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Countries
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Other Identifiers
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ARGX-113-2202
Identifier Type: -
Identifier Source: org_study_id