Active not recruitingPHASE2INTERVENTIONAL

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

This study is looking at a new medicine called batoclimab for adults who have a condition affecting their nerves, called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Researchers want to find out how well batoclimab works and if it's safe. Some participants will receive batoclimab, while others will get a placebo (a dummy drug). This helps doctors understand the true effects of the new medicine. The study will last for up to 109 weeks, involving different stages where treatments might change. Participants will be monitored closely for safety. If you have CIDP and are considering new treatment options, this study might be relevant, but it's important to discuss it with your doctor first.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Immunovant Sciences GmbH

Enrolment target

277

Start

15 Dec 2022

Estimated completion

01 Jan 2027

Chronic Inflammatory Demyelinating Polyneuropathy

What is this study about?

This study is investigating a new medicine called batoclimab for adults who have a condition known as Chronic Inflammatory Demyelinating Polyneuropathy, often shortened to CIDP. CIDP is a long-term problem where your body's immune system mistakenly attacks the protective covering of your nerves, called myelin. This can lead to muscle weakness, numbness, and tingling, often in the arms and legs.

The main goal of this study is to see if batoclimab can effectively treatCIDP symptoms and if it's safe to use. To do this, some people taking part will receive batoclimab, while others will receive a placebo, which looks like the real medicine but contains no active drug. This comparison helps researchers determine if any changes observed are due to batoclimab itself, rather than other factors. Each participant's progress will be carefully checked throughout the study.

Understanding how new treatments like batoclimab work and if they are safe is very important for people living with CIDP. This research helps contribute to finding better ways to manage the condition and improve quality of life for patients.

Key takeaways

This study is for adults with CIDP.
It's testing a new drug called batoclimab against a dummy drug (placebo).
Participation involves regular clinic visits and weekly injections.
The study could last for about two years.
You'll be closely monitored for safety and how well the treatment works.
You can leave the study at any time.

Who may be eligible?

To join this study, you must be 18 years old or older. You also need to have been diagnosed with CIDP. This includes the typical type of CIDP, or certain variations like multifocal CIDP, focal CIDP, or motor CIDP. Doctors will check your medical history and symptoms to confirm your diagnosis based on internationally recognised guidelines.

For some parts of the study, your CIDP diagnosis will also need to be supported by specific nerve tests called electrodiagnostic tests. These tests help doctors confirm the nerve damage characteristic of CIDP. In some cases, if the nerve tests aren't quite as clear, other things like showing improvement with past CIDP treatments, nerve imaging (like ultrasound or MRI), or having certain results from a spinal fluid test might also help you qualify.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with CIDP or a specific variant of it?
For some parts of the study, do your nerve tests support a CIDP diagnosis, or have you shown improvement with past CIDP treatments, or have specific nerve imaging/spinal fluid results?
Are you able to commit to weekly injections and regular clinic visits for up to two years?

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

What does participation involve?

If you join this study, your journey will begin with a 'Screening Period' of up to 4 weeks, where doctors will check if the study is right for you. After this, if you're on certain CIDP medications, there might be a 'washout period' of up to 12 weeks where you stop those medications under medical supervision.

Next, you'll enter a 12-week 'Randomized Treatment Period'. During this time, you'll receive either batoclimab or a placebo as a small injection under your skin, once a week. After this, you might move into a 'Randomized Withdrawal Period' for up to 24 weeks, where your treatment might be adjusted. There's also an optional 'Long-term Extension Period' that could last up to 52 weeks, depending on how things are going.

Throughout the study, you'll have regular visits for assessments, which might include physical examinations, blood tests, and checking your symptoms. The total time you could be involved in the study, from start to finish, is up to about 109 weeks (just over two years). After your last dose of the study treatment, there will be a final safety check-up about 4 weeks later.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as gaining access to a new treatment (batoclimab) before it's widely available, and receiving close medical attention and monitoring throughout the study. However, there are also potential risks, including side effects from batoclimab (which are not fully known yet), side effects from the placebo, or your CIDP symptoms getting worse. You might also experience discomfort from procedures like blood tests. It's crucial to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (116)

Site Number - 1603
Scottsdale, United States
Site Number - 1618
Carlsbad, United States
Site Number - 1634
Los Angeles, United States
Site Number - 1619
Orange, United States
Site Number - 1608
San Francisco, United States
Site Number - 1625
Aurora, United States
Site Number - 1636
Fort Collins, United States
Site Number - 1621
New Haven, United States
Site Number - 1630
Washington D.C., United States
Site Number - 1600
Boca Raton, United States
Site Number - 1609
Jacksonville, United States
Site Number - 1631
Orlando, United States

+104 more sites — see the official record for the full list.

Common questions

What is CIDP?

CIDP is a long-term condition where your body's immune system attacks the protective covering of your nerves, leading to weakness, numbness, and tingling.

What is batoclimab?

Batoclimab is a new medicine being tested in this study to see if it can help treat CIDP.

What is a placebo?

A placebo is a substance that looks like the study drug but doesn't contain any active medicine. It helps researchers compare the real drug's effects.

How will I receive the treatment?

You will receive the treatment (batoclimab or placebo) as an injection under your skin, once a week.

How long will the study last for me?

The study could last for up to about 109 weeks, which is just over two years, including check-ups.