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

Sponsor
argenx
Study ID
NCT05810948
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efgartigimod IV — BIOLOGICAL
    Intravenous (IV) infusion of efgartigimod
  • Placebo — OTHER
    Intravenous (IV) infusion of placebo

Study Details

The purpose of the study is 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.

Key Dates

Start date
Feb 21, 2023
Status verified
Oct 2025
Primary completion
Jul 2, 2025
Completion
Sep 1, 2025

Study Design

Enrollment
73 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: efgartigimod IV
    Patients receiving intravenous (IV) infusions of efgartigimod
  • Placebo Comparator: Placebo
    Patients receiving intravenous (IV) infusions of placebo

Primary Outcome Measure

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

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