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

Alexion Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Primary Membranous Nephropathy

Treatments: Drug: Placebo; Drug: ALXN1920

Study type: Interventional

Funder types: Industry

Identifiers

NCT07157787

2025-520780-40 (EudraCT Number)

ALXN1920-PMN-201 (Other Identifier)

D9900C00002

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (> 50 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.

• All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis

Exclusion criteria

• Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m^2 during Screening
• 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 < 50 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
• Use of SGLT2i, MRA, or ERA within 8 weeks prior to randomization and throughout the study period

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

ALXN1920

Experimental group

Description:

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

Treatment:

Drug: ALXN1920

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo