emvigorate
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
IRAS ID
1011796
Contact name
Sabine Coppieters
Contact email
Sponsor organisation
argenx BV
Eudract number
2024-520097-36
Clinicaltrials.gov Identifier
Research summary
The main purpose of this clinical trial is to research the effect (efficacy) and safety of a study drug called “empasiprubart” compared with intravenous immunoglobulin (IVIg) in participants with chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare condition in which the immune system attacks the nervous system, causing muscle weakness and a reduction in the ability to feel sensations in your legs and arms.
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 CIDP, that damage organs and tissues. Empasiprubart may help reduce this inflammation.
The study drug (empasiprubart, IVIg or placebo) is given as an intravenous infusion, an infusion into the participant's vein at the research site.
About 218 people are expected to be recruited globally, at multiple sites worldwide including the UK. The study will last for maximum of 47 months and will be divided in part A and part B. During the part A, participants will first receive either empasiprubart and placebo or IVIg and placebo for 24 weeks. During the part B, 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 CIDP status. Blood will be drawn and urine will be collected.
REC name
London - Fulham Research Ethics Committee
REC reference
26/LO/0080
Date of REC Opinion
13 Feb 2026
REC opinion
Further Information Favourable Opinion