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Looking for participantsPhase2

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

Sponsor: Alexion Pharmaceuticals, Inc.

NCT ID: NCT07157787

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ALXN1920 (drug), Placebo (drug)
How long the study runs
Study runs about 22 months (dates as stated)
About the drug or intervention
ALXN1920 — drug: Participants will receive ALXN1920 SC infusion. · Placebo — drug: Participants will receive Placebo SC infusion.
Patient visit burden
Not specified by the sponsor

In plain English

This study is looking at a medicine called ALXN1920 in adults with primary membranous nephropathy (PMN), a kidney condition where the immune system damages the kidneys' filters and causes protein to leak into the urine. The study is run by Alexion Pharmaceuticals, Inc. It aims to include people whose disease is at high risk of getting worse.

Who can take part

  • Adults with a confirmed diagnosis of primary membranous nephropathy, shown by a positive anti-PLA2R antibody blood test above 20 RU/mL, checked by a central laboratory
  • Willing to receive the standard care treatment used for this condition
  • At high risk of the disease getting worse, meaning: taking an ACE inhibitor or ARB blood pressure medicine for at least 8 weeks at the highest tolerated dose (or entering a run-in period if not yet done), blood pressure readings mostly under 140 mmHg, and two urine tests each showing more than 3.5 g of protein per day with no big drop between them
  • Kidney function (eGFR, a measure of how well the kidneys filter) of 60 mL/min/1.73 m² at screening
  • Willing to take preventive antibiotics while receiving rituximab and to be vaccinated against Neisseria meningitidis (a bacteria that can cause meningitis)

Who may not be able to

  • Recent rapid worsening of kidney function
  • A history of life-threatening nephrotic syndrome within 1 year before screening
  • Membranous nephropathy that is not caused by anti-PLA2R antibodies, anti-PLA2R positive disease with a screening level below 20 RU/mL, or another kidney disease
  • Past or planned kidney transplant, or planned dialysis during the treatment period
  • Past or planned transplant of another organ (heart, lung, small bowel, pancreas, liver) or bone marrow during the study
  • Other significant health conditions
  • Allergy or bad reaction to ACE inhibitors or ARBs
  • Starting or changing the dose of SGLT2 inhibitor medicines within 12 weeks before joining, or planning a change during the study
  • Use of traditional Chinese medicines with immune-suppressing effects within 6 months before screening
  • Use of MRA or ERA medicines within 12 weeks before joining or during the study

What taking part involves

  • • Not stated — ask the trial team. The data mentions background standard of care, ACE inhibitors or ARBs, preventive antibiotics with rituximab, and vaccination against Neisseria meningitidis, but does not describe the full treatment plan.

Time commitment: Not stated — ask the trial team. The data does not say how long the study lasts, how many visits are needed, or exactly what taking part involves, other than standard care, blood tests and some people starting a run-in period.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
30
Started
2025-09-19
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for primary membranous nephropathy
  • • Phase2 - 30 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with primary membranous nephropathy

Where?

  • • Cambridge - Research Site
  • • Leicester - Research Site
  • • London - Research Site
  • • Salford - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Primary Membranous Nephropathy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

Biomarkers mentioned

established by positivePLA2R positive

What the study is looking for

  • ✓Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 20 RU/mL)...
  • ✓Participants are willing to receive the background the usual treatment (SoC)
  • ✓Participants at high risk for disease progression, defined as:
  • ✓Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \< 140 mmHg in ≥...
  • ✓Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the...

Who cannot take part

  • ✗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...
  • ✗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...
See the full criteria
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.

Where Is This Study? (4 UK sites)

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

How to Get in Touch

Alexion Pharmaceuticals, Inc. (Sponsor)

Sponsor contact

CONTACT

1-855-752-2356 clinicaltrials@alexion.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06