The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).
Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (> 20 RU/mL) at Screening, which must be confirmed by a central laboratory
Participants are willing to receive the background Standard of Care (SoC)
Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period.
Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure < 140 mmHg in ≥ 75% of the readings within last 8 weeks.
Documented rapid deterioration of kidney function
History of life-threatening Nephrotic Syndrome within 1 year before Screening
Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R < 20 RU/mL or kidney disease other than PMN
History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
Parallel
ALXN1920
DrugParticipants will receive ALXN1920 SC infusion.
Placebo
DrugParticipants will receive Placebo SC infusion.
Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26
Change From Baseline in Proteinuria Based on 24-hour UPCR at week 12
Change From Baseline in Proteinuria Based on Spot UPCR at Week 12 and week 26
Change From Baseline in Serum Albumin at Week 12 and week 26
Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 12 and week 26
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Alexion Pharmaceuticals, Inc.
Lead sponsor
AstraZeneca
Collaborator
