Safety and Efficacy Study of VIS649 for IgA Nephropathy

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

• 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 8%.
• Participant has uncontrolled BP (> 140 mm Hg systolic or > 90 mm Hg diastolic)
• Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis.
• Participant has a known allergy or intolerance to any component of the study intervention.
• Participant is breastfeeding.
• Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Investigator.
• Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year.
• Participant has known cirrhosis or liver dysfunction, defined as presence of coagulopathy, platelet count 3× upper limit of normal.
• Participant has active malignancy or is receiving chemotherapy for malignancy, except for nonmelanoma skin cancers and cervical carcinoma in situ. Participants with prior malignancy who have been documented to be cancer-free for ≥ 5 years may be enrolled.
• Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening).
• Participant enrolled in another investigational drug or device study within 3 months prior to initial screening.
• Participant with a pre-existing illness other than those listed above that, in the opinion of the Investigator, would place the participant at increased risk through participation in this study.
• Participant is unable to comply with study protocol procedures and/or study visit schedules.
• Participant with known or suspected alcohol or drug abuse that would compromise their safety or study participation of the participant, in the opinion of the Investigator.