RecruitingPHASE2INTERVENTIONAL

Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This research study is looking at a new treatment called Imeroprubart for adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a long-term condition where the body's immune system mistakenly attacks its own nerves, leading to muscle weakness, numbness, and tingling. This study, called a Phase 2 trial, aims to find out if Imeroprubart is effective in treating CIDP and if it's safe for patients to use. Participants will be randomly given either Imeroprubart or a placebo (a dummy treatment with no active medicine) to fairly assess the new drug's effects. The hope is to find a better way to manage CIDP symptoms.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Immunovant Sciences GmbH

Enrolment target

162

Start

18 Mar 2025

Estimated completion

01 May 2030

Chronic Inflammatory Demyelinating Polyneuropathy

What is this study about?

This study is designed to explore a new potential treatment called Imeroprubart for adults who live with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a condition where your body's defence system, called the immune system, mistakenly attacks the protective coating around your nerves. This can lead to problems like muscle weakness, numbness, and tingling sensations, making everyday activities difficult.

The main goal of this particular study is to see how well Imeroprubart works and if it's safe to use. To do this fairly, some participants will receive Imeroprubart, while others will receive a placebo – which looks exactly like the study medicine but contains no active drug. This is a common way to test new treatments to make sure any improvements are truly due to the new medicine and not just other factors. Everything is done with great care to make sure the study methods are sound and ethical.

Understanding if Imeroprubart can help people with CIDP is really important. Current treatments can help manage symptoms, but there's always a need for new and potentially better options. This research could lead to a new way to help people with CIDP improve their quality of life and manage their symptoms more effectively.

Key takeaways

This study is testing a new medicine, Imeroprubart, for CIDP.
It's a Phase 2 trial, meaning researchers are looking at how well it works and its safety.
Some participants will get the new medicine, others will get a dummy treatment (placebo).
You'll have regular hospital visits for check-ups and monitoring.
Participation is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, adults must have been officially diagnosed with CIDP or one of its specific types (like multifocal or motor CIDP) using the latest medical guidelines. Your nerve tests must also clearly show signs of CIDP. You also need to be already receiving a stable dose of CIDP treatment, such as steroids or immunoglobulin therapy, for at least three months before the study starts.

There are several reasons why someone might not be able to join. For example, if you have certain other nerve conditions that are not CIDP, such as some types of diabetes-related nerve damage or other specific nerve diseases, then this study might not be right for you. Also, if you have certain blood conditions or a history of specific spinal cord issues, you might not be eligible.

The medical team will carefully review all your medical information, including your full health history and any other conditions you might have, to make sure this study is safe and appropriate for you.

Quick self-check

Are you an adult with a confirmed diagnosis of CIDP?
Do your nerve tests support a CIDP diagnosis?
Have you been on stable doses of CIDP treatment (like steroids or immunoglobulin therapy) for at least 3 months?
Do you have any other specific nerve conditions or health issues that might prevent you from joining?

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

What does participation involve?

If you decide to take part in this study, the doctors and nurses will closely monitor your health and how you respond to the treatment. You'll be randomly assigned to either receive Imeroprubart or the placebo. Neither you nor your study doctor will know which treatment you are receiving until the end of the study. This helps ensure fair results.

You will have regular appointments at the study clinic, where you'll have physical examinations, blood tests, and other assessments to check your CIDP symptoms and overall health. The study team will provide you with the medication, and you'll receive careful instructions on how to take it. There will also be follow-up visits after the main treatment period to see how you are doing. The total duration of your participation in the study, including all treatments and follow-up visits, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as receiving a new investigational treatment for CIDP and close medical monitoring. However, there are also potential risks, including side effects from the study medication, which may be unknown or severe. The placebo group will not receive the active study drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and this decision will be fully respected.

Locations (135)

Site Number - 1612
Tucson, United States· Recruiting
Site Number - 1618
Carlsbad, United States· Recruiting
Site Number - 1619
Orange, United States· Recruiting
Site Number - 1607
Rancho Mirage, United States· Recruiting
Site Number -1608
San Francisco, United States· Recruiting
Site Number - 1626
Parker, United States· Recruiting
Site Number - 1621
New Haven, United States· Recruiting
Site Number - 1630
Washington D.C., United States· Recruiting
Site Number - 1601
Washington D.C., United States· Recruiting
Site Number - 1603
Maitland, United States· Recruiting
Site Number - 1606
Miami, United States· Recruiting
Site Number - 1617
Ormond Beach, United States· Recruiting

+123 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 rare, long-term condition where the body's immune system attacks the nerves, causing weakness, numbness, and tingling.

What is Imeroprubart?

Imeroprubart is an investigational medicine being tested in this study to see if it can help treat adults with CIDP. It's not yet approved for general use.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the new medicine accurately.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving Imeroprubart or the placebo until after the study is complete.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Study Contact

clinicaltrials@immunovant.com 18007970414 Official trial record

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