RecruitingPHASE3INTERVENTIONAL

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

This study is investigating a new medicine called empasiprubart for adults living with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It aims to see how empasiprubart compares to the standard treatment, IVIg, in terms of safety and how well it helps control CIDP. The study is split into two parts. In Part A, participants will either get empasiprubart and a dummy IVIg treatment, or IVIg and a dummy empasiprubart treatment, for about six months. After this, everyone in Part B will receive empasiprubart for nearly two years. This research is important to understand if empasiprubart could be a helpful new option for people with CIDP.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

argenx

Enrolment target

218

Start

22 Aug 2025

Estimated completion

01 Sep 2030

Chronic Inflammatory Demyelinating Polyneuropathy CIDP CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

What is this study about?

This research study is looking at a new medicine called empasiprubart for people who have a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare, long-term condition that affects your nerves, leading to muscle weakness and numbness, usually in your arms and legs. It's an autoimmune disease, which means your body's immune system mistakenly attacks your own nerve coverings.

The main goal of this study is to compare empasiprubart with a common treatment for CIDP, which is called Intravenous Immunoglobulin, or IVIg. Doctors want to see if empasiprubart is as effective as IVIg, or even better, at managing CIDP symptoms and if it's safe to use. Finding new and better treatments is really important for people living with CIDP.

The study is divided into two main stages. For the first stage, called Part A, which lasts for about six months, participants will be randomly assigned to one of two groups. One group will receive the new medicine, empasiprubart, along with a 'dummy' or placebo version of IVIg. The other group will receive the standard IVIg treatment along with a 'dummy' version of empasiprubart. This is done so researchers can fairly compare the effects. After Part A, everyone in the study will then go into Part B, where they will all receive empasiprubart for about two years. This allows researchers to gather a lot of information on the long-term safety and effectiveness of empasiprubart.

Key takeaways

Compares a new medicine (empasiprubart) with standard treatment (IVIg) for CIDP.
Study lasts for about 2.5 years, split into two main parts.
First part involves a 'blinded' comparison to ensure fair results.
Second part gives all participants the new medicine, empasiprubart.
Suitable for adults with specific types of CIDP who have responded to IVIg before.
Close medical monitoring throughout the study period.

Who may be eligible?

To be able to join this study, adults must have a confirmed diagnosis of CIDP, including certain types like typical, motor, multifocal, focal, or distal CIDP. You also need to have responded well to IVIg treatment in the past five years and currently be receiving IVIg regularly to manage your CIDP. Importantly, you should still be experiencing some symptoms or disability from your CIDP, even with your current treatment.

There are some reasons why you wouldn't be able to join. For instance, if you have other serious health conditions that might make it hard to understand how the CIDP treatment is working, or if it puts your health at risk. You also can't take part if your CIDP diagnosis is classified as 'possible' or 'sensory' only, or if you're currently using other similar long-term immune-system modifying medicines.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or older?
Do you have a confirmed diagnosis of CIDP (not just 'possible' or 'sensory' type)?
Have you responded well to IVIg treatment for your CIDP in the last 5 years?
Are you currently receiving regular IVIg treatment for your CIDP?
Do you still have some ongoing symptoms or difficulties from your CIDP despite your current treatment?
Do you have any other significant medical conditions that might complicate taking part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve regular visits to a clinic over an extended period. For the first six months (Part A), you'll receive either the new medicine (empasiprubart) or the standard treatment (IVIg), along with a dummy placeholder, through infusions. Both you and the study team won't know which one you are receiving during this time. You'll have various checks and assessments, which might include physical examinations, blood tests, and questionnaires, to see how you're feeling and how your CIDP is responding to treatment.

After these six months, if you continue into Part B, you will then receive empasiprubart, regardless of what you received in Part A, for approximately two years. Throughout the entire study, the research team will closely monitor your health and any side effects you might experience. They will also keep track of changes in your CIDP symptoms. The total time you would be involved in the study, including follow-up, could be around 2.5 years.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. Potential benefits might include access to a new treatment, empasiprubart, which could improve your CIDP symptoms. Your health will also be closely monitored by medical professionals throughout the study. However, there are potential risks, such as side effects from the study medication, which may or may not be known yet. The treatment you receive might also not be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (75)

Samir Macwan, M.D., Inc.
Verified postcode
Rancho Mirage, United States· Recruiting
Colorado Springs Neurological Associates
Verified postcode
Colorado Springs, United States· Recruiting
MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States· Recruiting
Homestead Associates in Research Inc
Verified postcode
Homestead, United States· Recruiting
Visionary Investigators Network
Verified postcode
Miami, United States· Recruiting
University of South Florida
Verified postcode
Tampa, United States· Recruiting
Paradigm Health System
Verified postcode
Slidell, United States· Recruiting
Erlanger Health System
Verified postcode
Columbia, United States· Recruiting
University of Michigan Hospital
Verified postcode
Ann Arbor, United States· Recruiting
NeuroCarePlus
Verified postcode
Houston, United States· Recruiting
National Neuromuscular Research Institute
Verified postcode
Irving, United States· Recruiting
INECO Neurociencias Oroño
Verified postcode
Rosario, Argentina· Recruiting

Common questions

What is empasiprubart?

Empasiprubart is a new medicine being tested to see if it can help adults with CIDP by reducing their symptoms.

What is IVIg?

IVIg, or Intravenous Immunoglobulin, is a standard treatment for CIDP that involves giving your body healthy antibodies through an infusion.

Will I know which treatment I am getting?

In the first part of the study (Part A), you and the study doctors won't know if you're getting empasiprubart or IVIg. This helps ensure fair results.

How long will the study last?

The study lasts for about 2.5 years in total, with the first part being around six months and the second part around two years.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.

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.