Safety and Efficacy Study of VIS649 for IgA Nephropathy

Inclusion criteria

• . Participant is a male or female ≥ 18 years of age at the time of signing the informed consent.
• . Participant must have biopsy-confirmed IgAN.
• . Participant has medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening. Participants should optimally be on at least 50% of the maximum recommended dose of these agents; however, if a participant is on their maximally tolerated dose (and this is \< 50% of the maximum recommended dose) and has been on this dose for at least 3 months, they may be enrolled. Participants who are unable to tolerate ACEI/ARB therapy may be eligible for participation in the study if their overall management of IgAN, including BP control, is as per local SOC and applicable guidelines.
• . Participants must have screening uPCR ≥ 0.75 g/g measured from a 24-hour urine or 24-hour urine protein ≥ 1.0 g/d, as measured from 24-hour urine collection. The proteinuria should be assessed when the participant is considered to be in a steady state with no recent heavy exercise, fever, or other potential issues that could impact the result.
• . Participants must have eGFR ≥ 45 mL/min/1.73 m² using the CKD-EPI formula.
• . Participant's serum Ig values must meet specified criteria
• . Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose.
• . Participant is willing to adhere to contraceptive requirements.