The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.
Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age inclusive, at the time of signing the informed consent.
Diagnosis of anti-PLA2R antibody-positive pMN.
All participants must have received SoC therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for ≥ 4 weeks, with exceptions in case of intolerance, contraindications, or low blood pressure, before the screening period.
Positive for anti-PLA2R.
Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies < 9 months before screening.
Immunomodulatory therapy <3 months before screening.
Secondary causes of membranous nephropathy
Diabetes mellitus with haemoglobin A1C > 8.5% tested at screening visit.
Sequential
Surovatamig
DrugParticipants will receive Surovatamig subcutaneously
Number of participants with adverse events.
To assess the safety and tolerability of surovatamig on adverse events, including Adverse events, Serious adverse events, Adverse event of special interests, and Adverse events leading to discontinuation of surovatamig.
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection)
To assess the effect of surovatamig on proteinuria
Percentage of participants achieving complete or partial remission of pMN
To evaluate the proportion of participants who achieve partial and/or complete remission
Percentage of participants achieving complete remission of pMN
To evaluate the proportion of participants who achieved complete remission
Percentage of participants achieving partial remission of pMN
To evaluate the proportion of participants who achieve partial remission
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection)
To assess the effect of surovatamig on proteinuria
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