RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

This study is called CAPTIVATE and it's looking into a new treatment called claseprubart (also known as DNTH103) for a condition called Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP. CIDP is a long-term problem that affects the nerves. The main goal of this study is to see if claseprubart is effective in treating CIDP and to check if it's safe for people to use. Some people taking part will get the new drug, while others will get a placebo (a dummy treatment with no active drug). This helps doctors understand if the new drug is truly making a difference. The study involves different stages, including an initial period to see how people respond, followed by a longer period where participants are randomly assigned to either the drug or the placebo, and then an optional extended treatment period.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Dianthus Therapeutics

Enrolment target

256

Start

10 Feb 2025

Estimated completion

31 Dec 2030

Chronic Inflammatory Demyelinating Polyneuropathy

What is this study about?

This research study, called CAPTIVATE, is exploring a new medicine called claseprubart for a condition known as Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP. CIDP is a rare, long-term condition where your body's immune system mistakenly attacks the protective covering (myelin) around your nerves. This can lead to muscle weakness, numbness, tingling, and other nerve problems that can get worse over time or come and go.

The main aim of this study is to find out if claseprubart can help improve symptoms for people with CIDP and to learn about any side effects it might have. Researchers want to compare the effects of this new drug against a 'dummy' treatment (called a placebo). By doing this, they can be more certain if any changes seen in participants are truly due to the new medicine and not just other factors.

Taking part in a study like this is important because it can help develop new and better ways to treat conditions such as CIDP. The information gathered will contribute to a better understanding of the condition and how new treatments might work, potentially benefiting many others in the future.

Key takeaways

This study is testing a new drug, claseprubart, for CIDP.
It aims to see if the drug is effective and safe.
Some people will get the new drug, others will get a dummy treatment (placebo).
Participation involves regular clinic visits for assessments.
The study has different stages, potentially lasting over a year.
You can withdraw at any time without affecting your usual care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old, and your doctor must have diagnosed you with CIDP. This diagnosis needs to be confirmed by a special panel of experts. Your CIDP symptoms also need to be at a certain level, and your general nerve health should be stable.

You might be able to take part if you are currently being treated for CIDP, have stopped treatment but responded well to it in the past, or if previous treatments haven't worked well for you. Even if you've never been treated for CIDP before, you could still be eligible. There are also specific requirements about your weight and having certain vaccinations.

For women, you either can't be able to have children or, if you can, you must agree not to get pregnant or donate eggs during the study and use effective contraception if you are sexually active with a male partner.

Quick self-check

Are you between 18 and 75 years old?
Do you have a confirmed diagnosis of CIDP?
Are your CIDP symptoms currently at a certain level?
Have you been vaccinated against certain bacteria (if required locally)?
If you are a woman, are you unable to have children, or would you use suitable contraception during the study?

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, the study will involve several stages. First, there's an initial period of up to 13 weeks where you would receive the new drug, claseprubart. If your condition improves during this time, you would then move into the main part of the study.

In the second part, which can last up to 52 weeks, you would be randomly assigned to receive either claseprubart or a placebo (a dummy drug). Neither you nor your study doctor would know which one you are receiving – this is called a 'double-blind' study and helps ensure the results are accurate. After these treatment periods, if you qualify, you might be able to continue receiving the drug in an optional extended part of the study for up to an additional 104 weeks. Throughout the study, you'll have regular visits to the clinic for assessments, which will include tests and checks to see how your condition is responding and to monitor your health. There will also be a safety follow-up period of 40 weeks after your treatment finishes.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive access to a new treatment for CIDP that is not yet widely available, and it could improve your symptoms. However, there's also a chance you might receive the placebo, meaning you wouldn't get the active drug, or the treatment might not work for you. There could also be side effects from the new drug, and clinic visits might take up your time. All potential risks will be thoroughly explained to you by the study team. Remember, deciding whether to join is entirely your choice, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (168)

Clinical Study Site
Birmingham, United States· Recruiting
Clinical Study Site
Phoenix, United States· Recruiting
Clinical Study Site
Scottsdale, United States· Recruiting
Clinical Study Site
Los Angeles, United States· Recruiting
Clinical Study Site
San Francisco, United States· Recruiting
Clinical Study Site
San Francisco, United States· Recruiting
Clinical Study Site
Washington D.C., United States· Recruiting
Clinical Study Site
Maitland, United States· Recruiting
Clinical Study Site
Tampa, United States· Recruiting
Clinical Study Site
Honolulu, United States· Recruiting
Clinical Study Site
Chicago, United States· Recruiting
Clinical Study Site
Edwardsville, United States· Recruiting

+156 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 body's immune system attacks the nerves, leading to weakness, numbness, and tingling.

What is claseprubart?

Claseprubart (also called DNTH103) is the new medicine being tested in this study to see if it can help people with CIDP.

What does 'placebo' mean?

A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active drug. It helps doctors see if the study drug is truly making a difference.

How long will the study last if I join?

The study has different parts, but the main treatment periods can last up to 52 weeks, with an optional extension for some people. There's also a follow-up period after treatment.

Will I know if I'm getting the drug or the placebo?

No, during the main part of the study, neither you nor your study doctor will know whether you are receiving claseprubart or the placebo. This is to ensure the results are fair and accurate.

How to find out more

Dianthus Clinical Contact Center

clinicaltrials@dianthustx.com 929-999-4055 Official trial record

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