NCT05810948已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- argenx
- 入组人数
- 73
- 试验地点
- 31
- 主要终点
- Change from baseline to week 24 in urine protein creatinine ratio (UPCR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
efgartigimod IV
Experimental
Patients receiving intravenous (IV) infusions of efgartigimod
干预措施: efgartigimod IV (Biological)
Placebo
Placebo Comparator
Patients receiving intravenous (IV) infusions of placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline to week 24 in urine protein creatinine ratio (UPCR)
时间窗: up to 24 weeks
次要结局
- 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)
- 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)
- Change from baseline to week 24 in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score(Up to 24 weeks)
研究者
研究点 (31)
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