A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Lupus Nephritis (ZL-1103-013)
- Conditions
- Lupus Nephritis
- Interventions
- Biological: efgartigimod IVOther: Placebo
- Registration Number
- NCT05810948
- Lead Sponsor
- argenx
- Brief Summary
To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 73
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description efgartigimod IV efgartigimod IV Patients receiving intravenous (IV) infusions of efgartigimod Placebo Placebo Patients receiving intravenous (IV) infusions of placebo
- Primary Outcome Measures
Name Time Method Change from baseline to week 24 in urine protein creatinine ratio (UPCR) up to 24 weeks
- Secondary Outcome Measures
Name Time Method 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 Treatment failure rate during treatment period 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 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
Trial Locations
- Locations (31)
Shandong Provincial Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, China
Liu Zhou Works Hospital
🇨🇳Liuzhou, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
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
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
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China