Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)

Inclusion Criteria:

• Male and female patients ≥ 18 years of age .
• Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have hada kidney biopsy performed within 36 months of the screening visit).
• Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior toscreening. Patients who are on a stable dose of SGLT2i may participate if treatmentwas initiated ≥3 months prior to screening. Patients who are unable to take an ACEI orARB may participate if their overall management conforms with standards of care andother protocol requirements.
• Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0g/day
• eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73m2), calculated using the CKD-EPI equation.)

Exclusion Criteria:

• Secondary forms of IgAN or IgA vasculitis.
• Coexisting chronic kidney disease other than IgAN.
• Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy,membranous nephropathy, or lupus nephritis. Hypertensive vascular changes areacceptable.
• Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). IfMEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, orcrescents in > 25% of glomeruli is exclusionary. This does not apply to theexploratory cohort.
• Nephrotic syndrome
• Serum IgG < 600 mg/dL at screening.
• Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks ofrandomization
• Participation in another interventional clinical trial and receipt of anotherinvestigational drug within 30 days prior to the administration of IMP or 5 half-livesfrom last investigational drug administration, whichever is longer.
• Chronic infectious disease, or acute infectious disease at time of screening.
• Type 1 diabetes, or poorly controlled Type 2 diabetes
• Uncontrolled hypertension The protocol provides additional information about these and other inclusion and exclusioncriteria.