Clinical trial NCT05810948: A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Lupus Nephritis (ZL-1103-013)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Lupus Nephritis
Keywords: Nephritis
Lupus Nephritis
Kidney Disease
Urologic Disease
Glomerulonephritis
Lead sponsor: argenx
Sponsor class: INDUSTRY
Collaborators: name: Zai Lab (Shanghai) Co., Ltd.
First posted: 2023-04-13
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline to week 24 in urine protein creatinine ratio (UPCR)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Proportion of participants achieving complete renal response (CRR) at week 24
timeFrame: up to 24 weeks
measure: Time to complete renal response (CRR)
timeFrame: up to 32 weeks
measure: Proportion of participants achieving partial renal response at week 24
timeFrame: up to 24 weeks
measure: Time to partial renal response (PRR)
timeFrame: up to 24 weeks
measure: Change from baseline to week 24 in estimated glomerular filtration rate (eGFR)
timeFrame: up to 24 weeks
measure: Change from baseline to week 24 in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score
timeFrame: up to 24 weeks
measure: Change from baseline to week 24 in the dosage of glucocorticoids
timeFrame: up to 24 weeks
measure: Treatment failure rate during treatment period
timeFrame: up to 24 weeks
measure: Proportion of participants achieving modified complete renal response (mCRR) at week 24
timeFrame: up to 24 weeks
measure: Efgartigimod serum concentration-time profile
timeFrame: up to 32 weeks
measure: Changes from baseline in levels of total IgG
timeFrame: up to 32 weeks
measure: Incidence of ADA against efgartigimod
timeFrame: up to 32 weeks
measure: Median changes in concentration from baseline over time in biomarkers (Anti-dsDNA, C3, C4 and CH50)
timeFrame: up to 32 weeks
measure: Change from baseline to week 24 in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Fujian
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guanzhou
country: China
facility: The First Affiliated Hospital,Sun Yat-sen University
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Hengyang
country: China
facility: First Affiliated Hospital of University of South China
city: Huainan
country: China
facility: The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
city: Jieyang
country: China
facility: Jieyang People's Hospital
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
city: Liuzhou
country: China
facility: Liu Zhou Works Hospital
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shenyang
country: China
facility: ShengJing Hospital of China Medical University
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Shijia Zhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an
country: China
facility: Shaanxi Provincial Hospital of Chinese Medicine
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
References: