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

NCT07157787 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: D9900C00002ALXN1920-PMN-2012025-520780-40
• Study Type: interventional
• Target: 30
• Locations: 10 countries
• Sites: 40

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).

Conditions

Primary Membranous Nephropathy

Keywords

Primary Membranous Nephropathy; PMN; ALXN1920

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26

  Baseline, Week 26

Secondary Outcomes (6)

• Change From Baseline in Proteinuria Based on 24-hour UPCR at week 12

  Baseline and week 12

• Change From Baseline in Proteinuria Based on Spot UPCR at Week 12 and week 26

  Baseline, Week 12 and Week 26

• Change From Baseline in Serum Albumin at Week 12 and week 26

  Baseline, week 12 and Week 26

• Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 12 and week 26

  Baseline, week 12 and week 26

• Change From Baseline in Peripheral CD19+ B Cell Count at Week 4, Week 8, Week 12 and Week 26

  Baseline, Weeks 4, 8, 12 and 26

Study Arms (2)

ALXN1920

EXPERIMENTAL

Participants will receive ALXN1920 subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.

Drug: ALXN1920

Placebo

EXPERIMENTAL

Participants will receive placebo subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.

Drug: Placebo

Interventions

ALXN1920 DRUG

Participants will receive ALXN1920 SC infusion.

ALXN1920

Placebo DRUG

Participants will receive Placebo SC infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• AstraZeneca: collaborator

Study Sites (40)

Research Site

Loma Linda, California, 92354, United States

RECRUITING

Research Site

San Diego, California, 92123, United States

RECRUITING

Research Site

Minneapolis, Minnesota, 55435, United States

RECRUITING

Research Site

Rochester, Minnesota, 55905, United States

RECRUITING

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site

Buenos Aires, 1425, Argentina

RECRUITING

Research Site

CABA, C1425AGC, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, 1280, Argentina

RECRUITING

Research Site

La Plata, B1902COS, Argentina

NOT YET RECRUITING

Research Site

Rosario, 2000, Argentina

RECRUITING

Research Site

Santa Fe, S3000EOZ, Argentina

WITHDRAWN

Research Site

Santa Fe, S3000, Argentina

WITHDRAWN

Research Site

Gosford, 2250, Australia

RECRUITING

Research Site

Parkville, 3050, Australia

RECRUITING

Research Site

Southport, 4222, Australia

RECRUITING

Research Site

Recife, 50670-901, Brazil

RECRUITING

Research Site

Salvador, 40301-155, Brazil

RECRUITING

Research Site

São Paulo, 04038-002, Brazil

RECRUITING

Research Site

São Paulo, 05403-000, Brazil

RECRUITING

Research Site

Baotou, 014010, China

RECRUITING

Research Site

Beijing, 100034, China

RECRUITING

Research Site

Guangzhou, 510080, China

RECRUITING

Research Site

Shenzhen, 518036, China

RECRUITING

Research Site

Créteil, 94010, France

WITHDRAWN

Research Site

Nice, 06000, France

RECRUITING

Research Site

Toulouse, 31059, France

RECRUITING

Research Site

Milan, 20122, Italy

RECRUITING

Research Site

Ranica, 24020, Italy

RECRUITING

Research Site

Torrette, 60126, Italy

RECRUITING

Research Site

Barcelona, 08025, Spain

RECRUITING

Research Site

Madrid, 28007, Spain

RECRUITING

Research Site

Seville, 41013, Spain

RECRUITING

Research Site

Toledo, 45007, Spain

RECRUITING

Research Site

Kaohsiung City, 81362, Taiwan

RECRUITING

Research Site

Taichung, 40705, Taiwan

RECRUITING

Research Site

Taoyuan District, 333, Taiwan

RECRUITING

Research Site

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Research Site

Leicester, LE5 4PW, United Kingdom

RECRUITING

Research Site

London, SE5 9RJ, United Kingdom

RECRUITING

Research Site

Salford, M6 8HD, United Kingdom

RECRUITING

Central Study Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356; clinicaltrials@alexion.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): July 2, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

AU (3); BR (4); TW (3); ES (4); AR (7); US (5); FR (3); IT (3); GB (4); CN (4)