Recruiting
Phase 2

ALXN1920

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT07157787

Conditions

Primary Membranous Nephropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALXN1920

Placebo

Study Details

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

Study ID

NCT07157787

Start date

Sep 19, 2025

Status verified date

Jun, 2026

Completion date

Jul 9, 2027

Anticipated

Primary completion date

Jul 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALXN1920

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

experimental: Placebo

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

Interventions

ALXN1920

Participants will receive ALXN1920 SC infusion.

Placebo

Participants will receive Placebo SC infusion.

Primary outcome measure

  • Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26 [ Time Frame: Baseline, Week 26 ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

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

Locations

Research Site

Recruiting

Loma Linda, California, United States, 92354

Research Site

Recruiting

San Diego, California, United States, 92123

Research Site

Recruiting

Minneapolis, Minnesota, United States, 55435

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

Research Site

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Primary Membranous Nephropathy
  • PMN
  • ALXN1920

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2026-06-18.