RecruitingPHASE2INTERVENTIONAL

A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

This study is looking into a new medicine called TAK-411 for adults who have Chronic Inflammatory Demyelinating Polyradiculoneuropathy, or CIDP. CIDP is a condition where your body's defence system mistakenly attacks the protective cover around your nerves, leading to muscle weakness and problems with feeling in your arms and legs. We want to find out if TAK-411, which is a specially modified form of a common CIDP treatment called immunoglobulin (IG), can help to lower inflammation and make CIDP symptoms better. The main goal is to compare how people's physical abilities change when taking TAK-411, against what we've learned from previous studies with a placebo (a dummy treatment). Participants would take the medicine for about a year and be closely monitored for a few weeks afterwards. There will be around 21 clinic visits during this time.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Takeda

Enrolment target

Start

14 May 2025

Estimated completion

08 Jun 2028

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

What is this study about?

Chronic Inflammatory Demyelinating Polyradiculoneuropathy, or CIDP, is a condition where your own body's immune system, which is meant to fight off infections, starts to attack the protective layer around your nerves, called myelin. Think of myelin like the insulation around an electrical wire; when it's damaged, the signals don't travel properly. This damage means your nerves can't send messages to your muscles very well, which can lead to muscle weakness, numbness, and tingling in your arms and legs.

Many people with CIDP are treated with a medicine called immunoglobulin (or IG for short). This study is looking at a new version of this medicine, called TAK-411. TAK-411 is made from human plasma, just like regular IG, but it has been specially altered. We want to see if this modified version can help reduce the inflammation in your nerves and improve your CIDP symptoms, such as muscle weakness and loss of sensation.

The main purpose of this study is to compare how well TAK-411 helps people with CIDP improve their physical abilities, compared to information we have from previous studies where some people received a dummy treatment (a placebo). This is a 'Phase 2' study, which means we are still in the earlier stages of testing this new medicine to understand if it's safe and how well it works.

Key takeaways

The study is testing a new medicine, TAK-411, for adults with CIDP.
TAK-411 is a modified version of a standard CIDP treatment (immunoglobulin).
The main goal is to see if TAK-411 improves physical functioning compared to historical placebo results.
Participation involves taking the medicine for about a year and around 21 clinic visits.
You must have a confirmed CIDP diagnosis and have responded to previous immunoglobulin treatment.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older. You must also have a clear diagnosis of CIDP that a specialist doctor has confirmed. Importantly, you should have responded well to previous immunoglobulin treatments for your CIDP at some point.

Your CIDP also needs to have been active or flared up within the last two years. This might mean your symptoms got worse when your IG dose was lowered or stopped, or that you needed a higher dose to feel better, or that your symptoms worsened just before your next IG treatment was due.

Currently, you should be on a stable dose of intravenous immunoglobulin (IGIV) treatment, meaning the dose hasn't changed much in the three months before screening for the study. There are also specific medical criteria that your doctor will check, and you must not have other types of nerve conditions that are similar to CIDP.

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 18 years old or older?
Do you have a confirmed diagnosis of CIDP from a specialist?
Have you responded to immunoglobulin treatment for your CIDP in the past?
Has your CIDP been active or flared up in the last two years?
Are you currently on a stable dose of intravenous immunoglobulin (IVIG) treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you could be receiving the study medication, TAK-411, for up to 51 weeks, which is almost a year. After your last dose, we'll continue to check on you for another 3 weeks to see how you're doing.

Throughout the study, you would need to visit the study clinic approximately 21 times. During these visits, the study team will carry out various tests and assessments to monitor your health, check your CIDP symptoms, and see how the medication is affecting you. They will also give you the study medication.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could improve your CIDP symptoms. However, as TAK-411 is still being tested, there's no guarantee it will work for you, and it might have side effects that we don't fully know yet. The study team will explain all known risks and closely monitor your health throughout the study to ensure your safety. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

University of California San Diego
Verified postcode
La Jolla, United States· Recruiting
California Pacific Medical Center
Verified postcode
San Francisco, United States· Recruiting
UF Health Neurology - Jacksonville
Verified postcode
Jacksonville, United States· Recruiting
Visionary Investigators Network
Verified postcode
Miami, United States· Recruiting
University of South Florida
Verified postcode
Tampa, United States· Recruiting
Emory University
Verified postcode
Atlanta, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting
Mayo Clinic Rochester
Verified postcode
Rochester, United States· Recruiting
The Curators of the University of Missouri on behalf of University of Missouri Health Care
Verified postcode
Columbia, United States· Recruiting
The Washington University
Verified postcode
St Louis, United States· Recruiting
Penn Blood Disorders Program - Hospital of The University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Houston Methodist Research Institute
Verified postcode
Houston, United States· Not yet recruiting

Common questions

What is CIDP?

CIDP is a condition where your immune system attacks the protective covering around your nerves, leading to muscle weakness and problems with feeling.

What is TAK-411?

TAK-411 is a new, specially altered type of immunoglobulin derived from human plasma, being tested as a treatment for CIDP.

How long will the study last for me?

You could be in the study for up to about a year, including taking the medication and a short follow-up period afterwards.

How many times will I visit the clinic?

You would likely need to visit the clinic around 21 times during the study.

Can I leave the study if I change my mind?

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

How to find out more

Takeda Contact

medinfous@takeda.com +1-877-825-3327 Official trial record

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