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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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Status and phase

Enrolling
Phase 2

Conditions

Lupus Nephritis

Treatments

Biological: efgartigimod IV
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05810948
ARGX-113-2202

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

efgartigimod IV
Experimental group
Description:
patients receiving infusions of efgartigimod
Treatment:
Biological: efgartigimod IV
Placebo
Placebo Comparator group
Description:
patients receiving infusions of placebo
Treatment:
Other: Placebo

Trial contacts and locations

30

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Central trial contact

Sabine Coppieters, MD

Data sourced from clinicaltrials.gov

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