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NCT Number: NCT07157787

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

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).

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.
  • 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.
  • 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.

Treatment and study plan

ALXN1920

Drug

Participants will receive ALXN1920 SC infusion.

Placebo

Drug

Participants will receive Placebo SC infusion.

Primary outcomes

  1. Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26

    Time frame: Baseline, Week 26

Secondary outcomes

  1. Change From Baseline in Proteinuria Based on 24-hour UPCR at week 12

    Time frame: Baseline and week 12

  2. Change From Baseline in Proteinuria Based on Spot UPCR at Week 12 and week 26

    Time frame: Baseline, Week 12 and Week 26

  3. Change From Baseline in Serum Albumin at Week 12 and week 26

    Time frame: Baseline, week 12 and Week 26

  4. Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 12 and week 26

    Time frame: Baseline, week 12 and week 26

  5. Change From Baseline in Peripheral CD19+ B Cell Count at Week 4, Week 8, Week 12 and Week 26

    Time frame: Baseline, Weeks 4, 8, 12 and 26

  6. Change From Baseline biomarker level at Week 12 and 26

    Time frame: Baseline and Weeks 12 and 26

Study contacts

Contact information is provided by the study sponsor or research team.

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

[email protected]

1-855-752-2356

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1920 in Adult Participants With PMN (Primary Membranous Nephropathy) Who Are at a High Risk for Disease Progression

Acronym: AUTUMN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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