To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN
This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN. Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Sibeprenlimab 400 mg s.c. q 4 weeks
Adverse Events
Time frame: From baseline to the end-of-trial visit in Week 112.
Annualized slope of Estimated Glomerular Filtration Rate (eGFR)
Time frame: Over 12 and 24 months
Urine protein/creatinine ratio (uPCR) in a 24-hour collection
Time frame: At 12 and 24 months
Proportion of Subjects with Clinical Remission as defined in the protocol
Time frame: At 12 and 24 months
Time to Progression of Chronic Kidney Disease, as defined in the protocol
Time frame: Over 24 months
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