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

Last updated: September 23, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Idiopathic Membranous Nephropathy

Treatment

ALXN1920

Placebo

Clinical Study ID

NCT07157787
D9900C00002
ALXN1920-PMN-201
2025-520780-40
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  • Participants who have a documented diagnosis of PMN, established by positiveantiPLA2R antibody level (> 50 RU/mL) at Screening, which must be confirmed by acentral 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 lessthan 8 weeks on ACE inhibitor or ARB before Screening or who have not yetreached maximally tolerated dose will enter the Run-in Period.

  2. Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks withSystolic Blood Pressure < 140 mmHg in ≥ 75% of the readings within last 8weeks.

  3. Having two proteinuria measurements with each > 3.5 g/day, the secondmeasurement showing ≤50% decrease from the first measurement.

  • All participants must receive prophylactic treatment with appropriate antibioticswhile receiving Rituximab (RTX), and be willing to be vaccinated against Neisseriameningitidis

Exclusion

Exclusion Criteria:

  • Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m^2 during Screening

  • 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 < 50 RU/mL or kidneydisease other than PMN

  • History of kidney transplant or planned kidney transplant or dialysis during theTreatment Period

  • History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bonemarrow 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

  • Use of SGLT2i, MRA, or ERA within 8 weeks prior to randomization and throughout thestudy period

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: ALXN1920
Phase: 2
Study Start date:
September 19, 2025
Estimated Completion Date:
March 12, 2027

Connect with a study center

  • Research Site

    Buenos Aires 3435910, 1425
    Argentina

    Site Not Available

  • Research Site

    CABA, C1425AGC
    Argentina

    Site Not Available

  • Research Site

    Ciudad de Buenos Aires, 1280
    Argentina

    Site Not Available

  • Research Site

    Rosario 3838583, 2000
    Argentina

    Site Not Available

  • Research Site

    Santa Fe 3836277, S3000EOZ
    Argentina

    Site Not Available

  • Research Site

    Gosford 2164849, 2250
    Australia

    Site Not Available

  • Research Site

    Parkville 2153770, 3050
    Australia

    Site Not Available

  • Research Site

    Southport 2148928, 4222
    Australia

    Active - Recruiting

  • Research Site

    Recife 3390760, 50670-901
    Brazil

    Site Not Available

  • Research Site

    Salvador 3450554, 40301-155
    Brazil

    Site Not Available

  • Research Site

    São Paulo 3448439, 05403-000
    Brazil

    Site Not Available

  • Research Site

    Baotou 2038432, 014010
    China

    Site Not Available

  • Research Site

    Beijing 1816670, 100034
    China

    Site Not Available

  • Research Site

    Guangzhou 1809858, 510080
    China

    Site Not Available

  • Research Site

    Shenzhen 1795565, 518036
    China

    Site Not Available

  • Research Site

    Créteil 3022530, 94010
    France

    Site Not Available

  • Research Site

    Nice 2990440, 06000
    France

    Site Not Available

  • Research Site

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Research Site

    Milan 6951411, 20122
    Italy

    Site Not Available

  • Research Site

    Ranica 6535785, 24020
    Italy

    Site Not Available

  • Research Site

    Torrette 8960841, 60126
    Italy

    Site Not Available

  • Research Site

    Barcelona 3128760, 08025
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Research Site

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Research Site

    Toledo 2510409, 45007
    Spain

    Site Not Available

  • Research Site

    Kaohsiung City 1673820, 81362
    Taiwan

    Site Not Available

  • Research Site

    Taichung 1668399, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Research Site

    Cambridge 2653941, CB2 0XY
    United Kingdom

    Site Not Available

  • Research Site

    Leicester 2644668, LE1 5WW
    United Kingdom

    Site Not Available

  • Research Site

    London 2643743, SE5 9RJ
    United Kingdom

    Site Not Available

  • Research Site

    Salford 2638671, M6 8HD
    United Kingdom

    Site Not Available

  • Research Site

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • Research Site

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Research Site

    Minneapolis 5037649, Minnesota 5037779 55435
    United States

    Site Not Available

  • Research Site

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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