A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephrit… (NCT05810948) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
China73 participantsStarted 2023-02-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fo…
What they're measuring
1
Change from baseline to week 24 in urine protein creatinine ratio (UPCR)