A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)

Lupus Nephritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810948
• Other study ID #: ARGX-113-2202
• Status: Recruiting
• Phase: Phase 2
• Start date: February 21, 2023
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: argenx
• Contact: Sabine Coppieters, MD
• Phone: 857-350-4834
• Email: clinicaltrials[@]argenx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN)

Description:

To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN). The study comprises a maximum 4-week screening period, a 24-week treatment period, and an 8-week follow-up period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• 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

• Received live/live-attenuated vaccine within 28 days before randomization. The receipt of any inactivated, subunit, polysaccharide, or conjugate vaccine at any time before screening is not considered exclusionary. It is recommended that participants are up to date with vaccination(s) before the first dose of IMP

• Previously participated in a clinical study with efgartigimod

• 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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Biological:
• efgartigimod IV
infusion of efgartigimod

Other:
• Placebo
infusion of placebo

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing
China	Peking University Third 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	Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan
China	Liu Zhou Works Hospital	Liuzhou
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	Henan Provincial People's Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (2)

Lead Sponsor	Collaborator
argenx	Zai Lab (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 24 in urine protein creatinine ratio (UPCR)		up to 24 weeks
Secondary	Proportion of participants achieving complete renal response (CRR) at week 24		up to 24 weeks
Secondary	Time to complete renal response (CRR)		up to 32 weeks
Secondary	Proportion of participants achieving partial renal response at week 24		up to 24 weeks
Secondary	Time to partial renal response (PRR)		up to 24 weeks
Secondary	Change from baseline to week 24 in estimated glomerular filtration rate (eGFR)		up to 24 weeks
Secondary	Change from baseline to week 24 in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score		up to 24 weeks
Secondary	Change from baseline to week 24 in the dosage of glucocorticoids		up to 24 weeks
Secondary	failure rate during treatment period		up to 24 weeks
Secondary	Proportion of participants achieving modified complete renal response (mCRR) at week 24		up to 24 weeks
Secondary	Efgartigimod serum concentration-time profile		up to 32 weeks
Secondary	Changes from baseline in levels of total IgG		up to 24 weeks
Secondary	Incidence of ADA against efgartigimod		up to 24 weeks
Secondary	Median changes in concentration from baseline over time in biomarkers (Anti-dsDNA, C3, C4 and CH50)	(all have the same measuring units)	up to 32 weeks