ALXN1920-PMN-201 - Phase 2a - ALXN1920 vs Placebo in Adult Pts. with PMN
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and lmmunogenicity of ALXN1920 in Adult Participants with PMN (Primary Membranous Nephropathy) who are at a High Risk for Disease Progression
IRAS ID
1012587
Contact name
Youssef Farag
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Research summary
The purpose of this phase 2a study is to determine if ALXN1920, an experimental drug, is safe and effective compared to placebo in adults with primary membranous nephropathy (PMN) at high risk of worsening disease. This study will assess kidney function, the frequency and severity of side effects compared to placebo, whether ALXN1920 triggers any unwanted immune reactions (immunogenicity), and how the drug acts in the body (pharmacodynamics) and how the body processes the drug (pharmacokinetics). ALXN1920 is designed to control overactivity of the complement system—a part of the immune system that can mistakenly damage kidney cells in PMN. By inhibiting this activity, ALXN1920 may help protect kidney function in affected patients. About 30 participants, aged 18–75, will be enrolled globally, including in the UK. Those who meet screening criteria will be randomly assigned to receive either weekly ALXN1920 or a placebo, in addition to their standard medications. The treatment, given under the skin, will last for 26 weeks, with a follow-up period of 4 weeks to monitor for side effects and disease changes. For every participant receiving placebo, two will receive ALXN1920. Participants will have regular health checks, including blood and urine tests and physical exams, to closely monitor their condition. The main risks include the chance of infection (particularly meningococcal infection), allergic reactions, and risks to pregnancy or nursing children. Preventive steps such as vaccination and antibiotics are included to reduce these risks.
The study is sponsored by Alexion Pharmaceuticals, Inc., and will run from October 2025 to December 2027 in countries such as the UK, USA, Argentina, Australia, Brazil, China, Taiwan, France, Italy, and Spain.
Taking part may offer closer health monitoring and potentially improved management of PMN, contributing to future treatment options for this difficult-to-treat condition.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
25/EE/0140
Date of REC Opinion
16 Oct 2025
REC opinion
Further Information Favourable Opinion