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NCT07157787PHASE2Recruiting

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

Alexion Pharmaceuticals, Inc.

Start Date

9/19/2025

Completion Date

7/9/2027

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

Age Range: 18 years to 75 years

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.

Interventions

DRUG

ALXN1920

DRUG

Placebo

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Conditions

Primary Membranous Nephropathy

Locations

Research Site

Loma Linda, California 92354

United States

Research Site

San Diego, California 92123

United States

Research Site

Minneapolis, Minnesota 55435

United States

Research Site

Rochester, Minnesota 55905

United States

Research Site

Houston, Texas 77030

United States

Research Site

Buenos Aires, 1425

Argentina

Research Site

CABA, C1425HFA

Argentina

Research Site

Ciudad de Buenos Aires, 1280

Argentina

Research Site

La Plata, B1902COS

Argentina

Research Site

Rosario, 2000

Argentina

Research Site

Santa Fe, S3000EOZ

Argentina

Research Site

Santa Fe, S3000

Argentina

Research Site

Gosford, 2250

Australia

Research Site

Parkville, 3050

Australia

Research Site

Southport, 4222

Australia

Research Site

Recife, 50670-901

Brazil

Research Site

Salvador, 40301-155

Brazil

Research Site

São Paulo, 04038-002

Brazil

Research Site

São Paulo, 05403-000

Brazil

Research Site

Baotou, 014010

China

Research Site

Beijing, 100034

China

Research Site

Guangzhou, 510080

China

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Shenzhen, 518036

China

Research Site

Créteil, 94010

France

Research Site

Nice, 06000

France

Research Site

Toulouse, 31059

France

Research Site

Milan, 20122

Italy

Research Site

Ranica, 24020

Italy

Research Site

Torrette, 60126

Italy

Research Site

Barcelona, 08025

Spain

Research Site

Madrid, 28007

Spain

Research Site

Seville, 41013

Spain

Research Site

Toledo, 45007

Spain

Research Site

Kaohsiung City, 81362

Taiwan

Research Site

Taichung, 40705

Taiwan

Research Site

Taoyuan, 333

Taiwan

Research Site

Cambridge, CB2 0QQ

United Kingdom

Research Site

Leicester, LE5 4PW

United Kingdom

Research Site

London, SE5 9RJ

United Kingdom

Research Site

Salford, M6 8HD

United Kingdom