NCT07157787 Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 30 participants in total. It began in 2025-09-19 with a primary completion date of 2027-07-02.

Brief Summary

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).

Eligibility Criteria

Inclusion Criteria: * 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) * Participants at high risk for disease progression, defined as: 1. 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. 2. 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. 3. Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement. * eGFR60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula * All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis Exclusion Criteria: * 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 * History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period * History or presence of any clinically relevant co-morbidities * History of intolerance or hypersensitivity to ACEi or ARB * Initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization or planned adjustment of GSLT2i dose throughout the treatment period. * Use of traditional Chinese medicines or Chinese proprietary medicines with systemic immunosuppressive properties within 6 months prior to screening. * Use of MRA, or ERA within 12 weeks prior to randomization and throughout the study period Note: Additional inclusion/exclusion criteria may apply, per protocol.

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