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

Primary Purpose

Lupus Nephritis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
efgartigimod IV
Placebo
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Nephritis, Lupus Nephritis, Kidney Disease, Urologic Disease, Glomerulonephritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Investigator site 1004Recruiting
  • Investigator site 1061Recruiting
  • Investigator site 1056Recruiting
  • Investigator site 1054Recruiting
  • Investigator site 1001Recruiting
  • Investigator site 1010Recruiting
  • Investigator site 1008Recruiting
  • Investigator site 1012Recruiting
  • Investigator site 1059Recruiting
  • Investigator site 10046Recruiting
  • Investigator site 1016Recruiting
  • Investigator site 1017Recruiting
  • Investigator site 1018Recruiting
  • Investigator site 1019Recruiting
  • Investigator site 1021Recruiting
  • Investigator site 1028Recruiting
  • Investigator site 1003Recruiting
  • Investigator site 1031Recruiting
  • Investigator site 1057Recruiting
  • Investigator site 1034Recruiting
  • Investigator site 1045Recruiting
  • Investigator site 1036Recruiting
  • Investigator site 1051Recruiting
  • Investigator site 1025Recruiting
  • Investigator site 1044Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

efgartigimod IV

Placebo

Arm Description

patients receiving infusions of efgartigimod

patients receiving infusions of placebo

Outcomes

Primary Outcome Measures

Change from baseline to week 24 in urine protein creatinine ratio (UPCR)

Secondary Outcome Measures

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

Full Information

First Posted
December 19, 2022
Last Updated
October 2, 2023
Sponsor
argenx
Collaborators
Zai Lab (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05810948
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx
Collaborators
Zai Lab (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 a maximum 4-week screening period, a 24-week treatment period, and an 8-week follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Nephritis, Lupus Nephritis, Kidney Disease, Urologic Disease, Glomerulonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
efgartigimod IV
Arm Type
Experimental
Arm Description
patients receiving infusions of efgartigimod
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients receiving infusions of placebo
Intervention Type
Biological
Intervention Name(s)
efgartigimod IV
Intervention Description
infusion of efgartigimod
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
infusion of placebo
Primary Outcome Measure Information:
Title
Change from baseline to week 24 in urine protein creatinine ratio (UPCR)
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Proportion of participants achieving complete renal response (CRR) at week 24
Time Frame
up to 24 weeks
Title
Time to complete renal response (CRR)
Time Frame
up to 32 weeks
Title
Proportion of participants achieving partial renal response at week 24
Time Frame
up to 24 weeks
Title
Time to partial renal response (PRR)
Time Frame
up to 24 weeks
Title
Change from baseline to week 24 in estimated glomerular filtration rate (eGFR)
Time Frame
up to 24 weeks
Title
Change from baseline to week 24 in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score
Time Frame
up to 24 weeks
Title
Change from baseline to week 24 in the dosage of glucocorticoids
Time Frame
up to 24 weeks
Title
failure rate during treatment period
Time Frame
up to 24 weeks
Title
Proportion of participants achieving modified complete renal response (mCRR) at week 24
Time Frame
up to 24 weeks
Title
Efgartigimod serum concentration-time profile
Time Frame
up to 32 weeks
Title
Changes from baseline in levels of total IgG
Time Frame
up to 24 weeks
Title
Incidence of ADA against efgartigimod
Time Frame
up to 24 weeks
Title
Median changes in concentration from baseline over time in biomarkers (Anti-dsDNA, C3, C4 and CH50)
Description
(all have the same measuring units)
Time Frame
up to 32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Information:
Facility Name
Investigator site 1004
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1061
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1056
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1054
City
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1001
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1010
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1008
City
Guanzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1012
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1059
City
Huainan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 10046
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1016
City
Liuzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1017
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1018
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1019
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1021
City
Nanning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1028
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1003
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1031
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1057
City
Shijia Zhuang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1034
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1045
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1036
City
Wuxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1051
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1025
City
Xiamen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1044
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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