ALXN1920 for adults with primary membranous nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized placebo-controlled interventional study gives participants either ALXN1920 or placebo alongside standard of care to measure effects on proteinuria. Eligible adults must have centrally confirmed anti‑PLA2R antibody >20 RU/mL and meet high‑risk criteria including nephrotic‑range proteinuria on repeated measurements and ACE inhibitor/ARB treatment or a run‑in. The primary outcome is change in 24‑hour urine protein‑creatinine ratio (UPCR) as a marker of disease activity and progression. Study visits are conducted at participating US research sites.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Loma Linda, California, United States Recruiting
• Research Site
  San Diego, California, United States Recruiting
• Research Site
  Minneapolis, Minnesota, United States Recruiting
• Research Site
  Rochester, Minnesota, United States Recruiting
• Research Site
  Houston, Texas, United States Recruiting
• Research Site
  Buenos Aires, Argentina Recruiting

Study contacts

• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surovatamig for adults with anti‑PLA2R primary membranous nephropathy

  This study will test whether subcutaneous surovatamig is safe and can reduce heavy proteinuria in adults with anti‑PLA2R–positive primary membranous nephropathy.

  Recruiting Phase 2 AstraZeneca · Los Angeles, California and 26 other locations · NCT07571746

• SHR-2173 injections for adults with primary membranous nephropathy

  This Phase II test will try SHR-2173 injections in adults (18–75) with biopsy-proven primary membranous nephropathy to see if they are safe, reduce disease activity, and to measure how the drug acts in the body.

  Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Nanjing, Jiangsu · NCT07289763

• Povetacicept for people with primary membranous nephropathy

  This trial tests whether povetacicept is safe and helps people with primary membranous nephropathy, with tacrolimus listed as an intervention in the protocol.

  Recruiting at 116 sites Phase 2/3 Vertex Pharmaceuticals Incorporated · Montgomery, Alabama and 116 other locations · NCT07204275

• Budoprutug for primary membranous nephropathy (Phase 2)

  This trial will test whether budoprutug, an anti-CD19 antibody given by IV, is safe and tolerated and may reduce proteinuria in adults with PLA2R-positive primary membranous nephropathy who still have high protein in their urine despite RAAS blockers.

  Recruiting at 35 sites Phase 2 Climb Bio, Inc. · Denver, Colorado and 37 other locations · NCT07096843

• Evaluating YK012 for treating primary membranous nephropathy

  This study is testing a new treatment called YK012 to see if it can help people with primary membranous nephropathy feel better and how safe it is to use.

  Recruiting Phase 1 Excyte Biopharma Ltd · Beijing, Beijing Municipality · NCT06982729

• Felzartamab infusions for adults with primary membranous nephropathy

  This study tests whether felzartamab infusions help adults with primary membranous nephropathy reach complete remission of proteinuria compared with tacrolimus.

  Recruiting at 116 sites Phase 3 Biogen · Huntsville, Alabama and 116 other locations · NCT06962800

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.