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Clinical Trials in the UK / NCT07157787
Recruiting Phase 2

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

NCT07157787 · tracked via the Priya Life Science UK tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 2
Started
2025-09-19
Last updated
2026-06-18

Condition(s) studied

Primary Membranous Nephropathy

Investigational drug(s) / intervention(s)

ALXN1920Placebo

ALXN1920: Participants will receive ALXN1920 SC infusion.

Placebo: Participants will receive Placebo SC infusion.

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Research Site Loma Linda California Recruiting
Research Site San Diego California Recruiting
Research Site Minneapolis Minnesota Recruiting
Research Site Rochester Minnesota Recruiting
Research Site Houston Texas Recruiting
Research Site Buenos Aires Argentina Recruiting
Research Site CABA Argentina Recruiting
Research Site Ciudad de Buenos Aires Argentina Recruiting
Research Site La Plata Argentina Not Yet Recruiting
Research Site Rosario Argentina Recruiting
Research Site Santa Fe Argentina Withdrawn
Research Site Santa Fe Argentina Withdrawn
Research Site Gosford Australia Active Not Recruiting
Research Site Parkville Australia Recruiting
Research Site Southport Australia Recruiting
Research Site Recife Brazil Recruiting
Research Site Salvador Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site Baotou China Recruiting
Research Site Beijing China Recruiting
Research Site Guangzhou China Recruiting
Research Site Shenzhen China Recruiting
Research Site Créteil France Withdrawn
Research Site Nice France Recruiting
Research Site Toulouse France Recruiting
Research Site Milan Italy Recruiting
Research Site Ranica Italy Recruiting
Research Site Torrette Italy Recruiting
Research Site Barcelona Spain Recruiting
Research Site Madrid Spain Recruiting
Research Site Seville Spain Recruiting
Research Site Toledo Spain Recruiting
Research Site Kaohsiung City Taiwan Recruiting
Research Site Taichung Taiwan Recruiting
Research Site Taoyuan Taiwan Recruiting
Research Site Cambridge United Kingdom Recruiting
Research Site Leicester United Kingdom Recruiting
Research Site London United Kingdom Recruiting
Research Site Salford United Kingdom Recruiting

More Alexion Pharmaceuticals, Inc. trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07157787 on ClinicalTrials.gov ↗ ← All trials in the UK