empassion
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy
IRAS ID
1011672
Contact name
Sabine Coppieters
Contact email
Sponsor organisation
argenx BV
Clinicaltrials.gov Identifier
Research summary
The main purpose of this clinical trial is to look at the effect (efficacy) and safety of “empasiprubart” compared with intravenous immunoglobulin (IVIg) treatment in participants with multifocal motor neuropathy (MMN). MMN is a condition in which the immune system attacks the nervous system, causing weakness in the hands, arms, and/or legs.
Empasiprubart is a therapeutic antibody that binds to a specific protein in the complement system, which is part of the immune system. The complement system has a central role in the body’s defense against infections. Sometimes, the complement system can become overactive and cause inflammation in the body. This inflammation may result in diseases or conditions, like MMN, that damage organs and tissues. Empasiprubart may help reduce this inflammation. The study drug (empasiprubart, IVIg, empasiprubart placebo, IVIg placebo) is given as an intravenous infusion, an infusion into the participant's vein at the research site.
About 100 people are expected to be recruited globally, at multiple sites worldwide including the UK.
The study will last for maximum of 49 months. During the treatment period, participants will first receive either empasiprubart and IVIg placebo or IVIg and empasiprubart placebo for 24 weeks. During the second part of the treatment period, all participants will receive empasiprubart for 24 months.
At the study visits, the participants will have a physical examination and an electrocardiogram. They will be asked to fill out some questionnaires and have physical tests to check their MMN status. Blood will be drawn and urine will be collected.REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0296
Date of REC Opinion
20 May 2025
REC opinion
Further Information Favourable Opinion