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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат ALXN1920
  Participants will receive ALXN1920 SC infusion.
• Препарат Placebo
  Participants will receive Placebo SC infusion.

Первичные конечные точки

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

Вторичные конечные точки (6)

• Change From Baseline in Proteinuria Based on 24-hour UPCR at week 12 [Срок оценки: Baseline and week 12]
• Change From Baseline in Proteinuria Based on Spot UPCR at Week 12 and week 26 [Срок оценки: Baseline, Week 12 and Week 26]
• Change From Baseline in Serum Albumin at Week 12 and week 26 [Срок оценки: Baseline, week 12 and Week 26]
• Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 12 and week 26 [Срок оценки: Baseline, week 12 and week 26]
• Change From Baseline in Peripheral CD19+ B Cell Count at Week 4, Week 8, Week 12 and Week 26 [Срок оценки: Baseline, Weeks 4, 8, 12 and 26]
• Change From Baseline biomarker level at Week 12 and 26 [Срок оценки: Baseline and Weeks 12 and 26]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Аргентина · 7 центров

• Research Site — Buenos Aires
• Research Site — CABA
• Research Site — Ciudad de Buenos Aires
• Research Site — La Plata
• Research Site — Rosario
• Research Site — Santa Fe
• Research Site — Santa Fe

США · 5 центров

• Research Site — Loma Linda
• Research Site — San Diego
• Research Site — Minneapolis
• Research Site — Rochester
• Research Site — Houston

Бразилия · 4 центра

• Research Site — Recife
• Research Site — Salvador
• Research Site — São Paulo
• Research Site — São Paulo

Китай · 4 центра

• Research Site — Baotou
• Research Site — Пекин
• Research Site — Гуанчжоу
• Research Site — Шэньчжэнь

Испания · 4 центра

• Research Site — Barcelona
• Research Site — Madrid
• Research Site — Seville
• Research Site — Toledo

Великобритания · 4 центра

• Research Site — Cambridge
• Research Site — Leicester
• Research Site — London
• Research Site — Salford

Австралия · 3 центра

• Research Site — Gosford
• Research Site — Parkville
• Research Site — Southport

Франция · 3 центра

• Research Site — Créteil
• Research Site — Nice
• Research Site — Toulouse

Италия · 3 центра

• Research Site — Milan
• Research Site — Ranica
• Research Site — Torrette

Тайвань · 3 центра

• Research Site — Kaohsiung City
• Research Site — Taichung
• Research Site — Taoyuan

Идентификаторы

NCT: NCT07157787 · D9900C00002 · ALXN1920-PMN-201 · 2025-520780-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗