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

Sponsor

argenx (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05810948

Collaborator

Zai Lab (Shanghai) Co., Ltd. (Industry)

Enrollment

Locations

Arms

19.3

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Biological: efgartigimod IV Other: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 21, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: efgartigimod IV patients receiving infusions of efgartigimod	Biological: efgartigimod IV infusion of efgartigimod
Placebo Comparator: Placebo patients receiving infusions of placebo	Other: Placebo infusion of placebo

Arm

Intervention/Treatment

Experimental: efgartigimod IV

patients receiving infusions of efgartigimod

Biological: efgartigimod IV

infusion of efgartigimod

Placebo Comparator: Placebo

patients receiving infusions of placebo

Other: Placebo

infusion of placebo

Outcome Measures

Primary Outcome Measures

Change from baseline to week 24 in urine protein creatinine ratio (UPCR) [up to 24 weeks]

Secondary Outcome Measures

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]
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 24 weeks]
Incidence of ADA against efgartigimod [up to 24 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Investigator site 1004	Beijing	China
2	Investigator site 1061	Changsha	China
3	Investigator site 1054	Fujian	China
4	Investigator site 1001	Guangzhou	China
5	Investigator site 1010	Guangzhou	China
6	Investigator site 1059	Huainan	China
7	Investigator site 1016	Liuzhou	China
8	Investigator site 1028	Shanghai	China
9	Investigator site 1031	Shenzhen	China
10	Investigator site 1036	Wuxi	China