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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 (AUTUMN)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520780-40-00
Acronym
ALXN1920-PMN-201
Enrollment
9
Registered
2025-11-20
Start date
2025-11-26
Completion date
Unknown
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Mebranous Nephropathy (PMN)

Brief summary

Change from Baseline in proteinuria based on 24-hour UPCR

Detailed description

Change from Baseline in proteinuria based on 24-hour UPCR, Change from Baseline in proteinuria based on spot UPCR, Change from Baseline in serum albumin, Change from Baseline in anti-PLA2R antibody level, Change from Baseline in Peripheral CD20+ B cell count, Change from Baseline for urine biomarkers, Change from Baseline for urine biomarkers, Incidence of TEAEs and TESAEs over time, Change from Baseline in safety parameters, vital signs, ECGs over time, Serum and urine ALXN1920 concentrations over time, Absolute values, change from Baseline, and percent change from Baseline in serum CAP activity and serum fH levels over time, ADA incidence, category of immune response, and titer through the duration of the study

Interventions

DRUGAlxn1920 placebo product

Sponsors

Alexion Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from Baseline in proteinuria based on 24-hour UPCR

Secondary

MeasureTime frame
Change from Baseline in proteinuria based on 24-hour UPCR, Change from Baseline in proteinuria based on spot UPCR, Change from Baseline in serum albumin, Change from Baseline in anti-PLA2R antibody level, Change from Baseline in Peripheral CD20+ B cell count, Change from Baseline for urine biomarkers, Change from Baseline for urine biomarkers, Incidence of TEAEs and TESAEs over time, Change from Baseline in safety parameters, vital signs, ECGs over time, Serum and urine ALXN1920 concentrations over time, Absolute values, change from Baseline, and percent change from Baseline in serum CAP activity and serum fH levels over time, ADA incidence, category of immune response, and titer through the duration of the study

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026