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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Primary Membranous Nephropathy

In brief

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).

Key facts

Study ID

NCT07157787

Run by

Alexion Pharmaceuticals, Inc.

People needed

30

Starts

2025-09-19

Expected to finish

2027-07-09

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.
• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Salford, United Kingdom (enrolling)
• Research Site — San Diego, California, United States (enrolling)
• Research Site — Minneapolis, Minnesota, United States (enrolling)
• Research Site — Rochester, Minnesota, United States (enrolling)
• Research Site — Houston, Texas, United States (enrolling)
• Research Site — Buenos Aires, Argentina (enrolling)
• Research Site — CABA, Argentina (enrolling)
• Research Site — Ciudad de Buenos Aires, Argentina (enrolling)
• Research Site — Taoyuan, Taiwan (enrolling)
• Research Site — Cambridge, United Kingdom (enrolling)
• Research Site — Leicester, United Kingdom (enrolling)
• Research Site — London, United Kingdom (enrolling)
• Research Site — Loma Linda, California, United States (enrolling)
• Research Site — Rosario, Argentina (enrolling)
• Research Site — Parkville, Australia (enrolling)
• Research Site — Southport, Australia (enrolling)
• Research Site — Recife, Brazil (enrolling)
• Research Site — Salvador, Brazil (enrolling)
• Research Site — São Paulo, Brazil (enrolling)
• Research Site — São Paulo, Brazil (enrolling)
• Research Site — Baotou, China (enrolling)
• Research Site — Beijing, China (enrolling)
• Research Site — Guangzhou, China (enrolling)
• Research Site — Shenzhen, China (enrolling)
• Research Site — Nice, France (enrolling)

Full record on ClinicalTrials.gov

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