A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
NCT05810948 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2025-12-18
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
efgartigimod IV
Intravenous (IV) infusion of efgartigimod
- OTHER
-
Placebo
Intravenous (IV) infusion of placebo
Sponsors & Collaborators
-
Zai Lab (Shanghai) Co., Ltd.
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-21
- Primary Completion
- 2025-07-02
- Completion
- 2025-09-01
Countries
- China
Study Locations
More Related Trials
-
A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis
NCT07229742 ·Status: RECRUITING ·Phase: PHASE2
-
An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis
NCT01273389 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.
NCT03610516 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
NCT00818948 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
NCT04058028 ·Status: COMPLETED ·Phase: PHASE2
-
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
NCT01172002 ·Status: UNKNOWN ·Phase: NA
-
Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
NCT00268567 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Phase IIa Study for IPG11406 in Patients With Lupus Nephritis
NCT06717815 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
NCT04924296 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
NCT04680637 ·Status: TERMINATED ·Phase: PHASE2
-
A Randomized, Controlled Clinical Study of Rituximab in Treatment of Primary IgA Nephropathy
NCT05824390 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
NCT06064929 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis
NCT03214731 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of Telitacicept in Lupus Nephritis
NCT05680480 ·Status: RECRUITING ·Phase: PHASE2
-
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
NCT05138133 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
NCT00705367 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of AMG 557 in Adults With Systemic Lupus Erythematosus
NCT00774943 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants
NCT05984251 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
NCT04564339 ·Status: TERMINATED ·Phase: PHASE2
-
Prognostic Factors for Treatment Responses in Patients With Active Lupus Nephritis at Sohag University Hospital
NCT04756492 ·Status: UNKNOWN
-
SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus
NCT06144710 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
NCT02954939 ·Status: RECRUITING ·Phase: NA
-
Clinical Study of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus
NCT06852573 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Anti-CD20 Antibodies for Treatment of SLE-PAH
NCT05828147 ·Status: RECRUITING ·Phase: PHASE4
-
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
NCT01930890 ·Status: TERMINATED ·Phase: PHASE2