RecruitingPHASE3INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

This study is looking at a new medicine called empasiprubart for adults who have a rare condition affecting the nerves called Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP. Researchers want to find out if empasiprubart is safe to use and if it can help improve symptoms. The study has two main parts. In the first part, for 6 months, some participants will receive empasiprubart, while others will receive a dummy medicine (placebo). This helps compare how well the new medicine works. After this, everyone in the study will receive empasiprubart for a longer period of 24 months. If you have CIDP and are interested in learning more about this potential new treatment, you can find more information about the study online.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

argenx

Enrolment target

160

Start

16 Sep 2025

Estimated completion

23 Jan 2031

Chronic Inflammatory Demyelinating Polyneuropathy CIDP Chronic Inflammatory Demyelinating Polyradiculoneuropathy

What is this study about?

This study is designed for adults living with a condition called Chronic Inflammatory Demyelinating Polyneuropathy, often shortened to CIDP. CIDP is a long-term condition where your body's immune system mistakenly attacks the protective covering around your nerves, which can lead to weakness, numbness, and other problems.

The main goal of this research is to test a new investigational medicine called empasiprubart. Researchers want to see if this medicine is both safe to use and effective in treating CIDP. This means they are looking to understand if it can help improve symptoms and your overall well-being if you have CIDP.

The study is divided into two phases. For the first 6 months (Part A), participants will be split into groups; some will receive empasiprubart, and others will receive a placebo (a dummy medicine with no active ingredients). This is a common way to properly test a new medicine. After this initial period, all participants will then receive empasiprubart for a further 24 months (Part B). This longer period helps researchers understand the medicine's effects over time.

Taking part in a study like this helps doctors learn more about new treatments, potentially leading to better care options for people with CIDP in the future.

Key takeaways

This study is for adults with CIDP to test a new medicine called empasiprubart.
It aims to see if empasiprubart is safe and effective in treating CIDP.
The study involves an initial 6 months where you might get the new medicine or a dummy medicine (placebo).
Following this, everyone gets empasiprubart for 24 months.
Regular clinic visits, tests, and assessments are part of participating.
You can stop participating at any time if you wish.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with CIDP. Your doctor must have diagnosed you with specific types of CIDP, such as typical CIDP, or variants like motor CIDP, multifocal CIDP, focal CIDP, or distal CIDP. You also need to have ongoing symptoms and some level of disability from your CIDP.

Whether you've never had CIDP treatment before, have stopped treatment, or are currently receiving treatments like steroids or IVIg, you might still be considered. However, if you are on existing CIDP treatment, you would need to be willing to stop your current treatment and switch to the study medicine if you join.

Some conditions would prevent you from joining. This includes certain types of CIDP like sensory-only CIDP, or if your nerve problems are caused by other medical conditions. If you have a condition called systemic lupus erythematosus (SLE) or have received specific long-term immune treatments or bone marrow transplants, you also wouldn't be able to take part.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with CIDP of specific types (not sensory-only)?
Are you currently experiencing symptoms and disability from your CIDP?
If you're on CIDP treatment, are you willing to stop it and switch to the study medicine?
Do you *not* have other conditions like systemic lupus erythematosus, or have had certain specific long-term immune treatments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, it involves a few key steps. Initially, for 6 months, you would either receive the new medicine, empasiprubart, through an intravenous (IV) drip, or a placebo (a dummy IV drip). Neither you nor your study doctor would know which one you are receiving during this first part of the study. After these 6 months, everyone who continues in the study will receive empasiprubart through an IV drip for a further 24 months.

Throughout the study, you would come to the clinic for regular visits. These visits would include blood tests, physical examinations, and questions about how you are feeling and any changes in your symptoms. These assessments help the doctors understand how the medicine is affecting your CIDP and your overall health. The total duration of your participation, if you complete both parts, would be about 30 months (2 and a half years).

Potential risks and benefits

Participating in a clinical trial offers the chance to try a new treatment that might improve your CIDP symptoms, possibly even before it's widely available. However, there's no guarantee the new medicine will help you, and it's possible you could receive a placebo initially. All medicines have potential side effects, and empasiprubart might cause its own side effects, which the study team will monitor closely. You will be closely watched by medical staff throughout the study, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (56)

Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, United States· Recruiting
Colorado Springs Neurological Associates
Colorado Springs, United States· Recruiting
Medstar Health Research Institute
Washington D.C., United States· Recruiting
Gables Neurology
Miami, United States· Recruiting
Aqualane Clinical Research
Naples, United States· Recruiting
Paradigm Health System
Slidell, United States· Recruiting
Penn Medicine University City
Philadelphia, United States· Recruiting
National Neuromuscular Research Institute
Austin, United States· Recruiting
NeuroCarePlus
Houston, United States· Recruiting
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Austria· Active not recruiting
Universitätsklinikum AKH Wien
Vienna, Austria· Recruiting
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
Sofia, Bulgaria· Active not recruiting

+44 more sites — see the official record for the full list.

Common questions

What is CIDP?

CIDP stands for Chronic Inflammatory Demyelinating Polyneuropathy. It's a condition where your immune system attacks the protective covering of your nerves, leading to weakness, numbness, and sometimes pain.

What is empasiprubart?

Empasiprubart is a new medicine being tested in this study. It's given through a drip (intravenously) and aims to help improve CIDP symptoms.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the true effects of the study medicine.

How long does the study last?

The study has two parts. The first part lasts 6 months, where you might receive empasiprubart or placebo. The second part lasts 24 months, where everyone receives empasiprubart, making the total study about 30 months long.

Can I continue my current CIDP medicine if I join?

No, if you are currently on CIDP treatment and decide to join, you would need to stop your current medicine before starting the study treatment.

How to find out more

Sabine Coppieters, MD

clinicaltrials@argenx.com 857-350-4834 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.