Overview
This is a Phase II open-label study to assess the safety, tolerability, Pharmacokinetics, and efficacy of surovatamig in adult participants with pMN, who are positive for anti-PLA2R antibodies and have heavy and persistent proteinuria with a high risk of progressing to end stage kidney disease.
The study will be conducted across approximately 30 to 40 study sites in approximately 10 countries. The study consists of 2 parts (Part A Multiple ascending with sentinel dosing and Part B Multiple ascending doses), with each consisting of 3 periods (ie, screening period, treatment period, and follow-up period; up to 26 months in total).
Principal investigator
Eligibility criteria
Exclusion Criteria: 1. Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies \< 9 months before screening. 2. Immunomodulatory therapy \<3 months before screening. 3. Secondary causes of membranous nephropathy 4. Diabetes mellitus with haemoglobin A1C \> 8.5% tested at screening visit. 5. Malignancies 6. History of HLH/MAS. 7 Significant CNS co-morbidity 8\. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator. 10\. Abnormal vital sign after 10 minutes sitting at rest. 11. Administration of corticosteroids such as prednisolone at doses exceeding 20 mg or an equivalent agent \< 2 months before screening.
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