Active not recruitingPHASE2INTERVENTIONAL

A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)

This research study, called MAGIC, is looking for adult volunteers aged 18-75 with generalized myasthenia gravis (gMG). The main goal is to test a new medicine, Claseprubart (also known as DNTH103), to see how safe it is, if people tolerate it well, and if it helps with their gMG symptoms. Participants will be randomly given either the new medicine or a dummy medicine (placebo) for 13 weeks. After this, some may have the option to continue receiving the new medicine for a longer period. We'll also be checking how the body reacts to the medicine and how effective it is over time. This study aims to find new and better ways to manage gMG.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Dianthus Therapeutics

Enrolment target

Start

23 Feb 2024

Estimated completion

01 Oct 2028

Myasthenia Gravis, Generalized

What is this study about?

Myasthenia gravis (say: my-ass-theen-ee-uh GRAY-viss), or MG, is a long-term condition that causes muscle weakness. When it affects many different muscles in the body, it's called generalized myasthenia gravis (gMG). This happens because your body's immune system mistakenly attacks the connections between your nerves and muscles, making it hard for messages to get through. This can lead to problems with things like eye movement, speaking, swallowing, and even breathing.

This study is called MAGIC, and its main purpose is to look at a new medicine called Claseprubart (also known as DNTH103). We want to find out if this medicine is safe for people with gMG and if it can help improve their muscle weakness. Researchers are also interested in understanding how the body uses and reacts to the medicine, and how well it works over time.

Finding new treatments is really important for people living with gMG, as current medicines don't work for everyone or can have side effects. Studies like this help doctors understand new ways to manage the condition, potentially leading to better quality of life for patients in the future.

Key takeaways

This study is for adults with generalized myasthenia gravis (gMG).
It's testing a new medicine called Claseprubart (DNTH103) for safety and effectiveness.
Participants will get either Claseprubart or a placebo for 13 weeks.
There's an optional longer treatment period if eligible.
Participation involves regular clinic visits and health monitoring.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with generalized myasthenia gravis (gMG). Your gMG needs to meet certain criteria, like showing positive results for specific tests (like the acetylcholine receptor antibody test) and affecting your daily activities enough to score 6 or more on a specific assessment tool.

There are also some important health checks. You must not have certain infections like HIV or hepatitis, and you shouldn't have had specific operations on your thymus gland recently. You also can't have a history of certain serious infections or cancers involving the thymus. For safety, you must have had specific vaccinations against meningitis either recently or when starting the study medicine. Women who could become pregnant and men must agree to either not get pregnant/get someone pregnant or use effective contraception during the study. You also need to weigh between 40 and 120 kilograms.

Certain past or current medical conditions or use of particular medicines might mean you can't join. The study team will go through all the details with you to make sure it's safe for you to take part.

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 between 18 and 75 years old?
Do you have a diagnosis of generalized myasthenia gravis (gMG)?
Have you been vaccinated against N. meningitidis recently or are you willing to be?
Are you able to attend regular clinic visits?
Do you weigh between 40-120 kg?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several stages. First, there's a 'screening' period, which can last up to 10 weeks, where doctors will do tests to make sure you're suitable for the study. After that, you'll enter the main 'treatment' period, which lasts 13 weeks. During this time, you'll be randomly given either the new medicine (Claseprubart) or a dummy medicine (placebo), and you won't know which one you're receiving. This is to ensure fair testing.

After the 13 weeks, if you are eligible and choose to, you might be able to continue receiving the new medicine in an 'open-label' period for up to 104 weeks, where everyone receives the active medicine. Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to see how your gMG symptoms are. There will also be a 'safety follow-up' period for 40 weeks after you stop taking the study medicine, where doctors will monitor your health.

Potential risks and benefits

Taking part in a study like this might offer some benefits, such as closely monitored care from specialists and access to a new medicine that isn't yet widely available. However, there are also potential risks, as with any new medicine. You might experience side effects, some of which could be unknown or serious. There's also a chance you could receive the placebo and not the active medicine during the main treatment phase, meaning your gMG symptoms might not improve. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (56)

Clinical Study Site
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Phoenix, United States
Clinical Study Site
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Irvine, United States
Clinical Study Site
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Stamford, United States
Clinical Study Site
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Boca Raton, United States
Clinical Study Site
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Bradenton, United States
Clinical Study Site
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Maitland, United States
Clincal Study Site
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Tampa, United States
Clinical Study Site
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O'Fallon, United States
Clinical Study Site
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Kansas City, United States
Clinical Study Site
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Lexington, United States
Clinical Study Site
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Boston, United States
Clinical Study Site
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East Lansing, United States

Common questions

What is generalized myasthenia gravis (gMG)?

It's a long-term condition that causes muscle weakness in many parts of your body due to your immune system attacking nerve-muscle connections.

What is Claseprubart (DNTH103)?

It's a new medicine being tested in this study to see if it's safe and helps improve gMG symptoms.

Will I get the new medicine or a dummy medicine?

During the main 13-week treatment period, you'll be randomly assigned to receive either the new medicine or a placebo (dummy medicine), and you won't know which one.

How long will I be in the study?

The initial screening is up to 10 weeks, followed by a 13-week treatment period. There's an optional longer treatment period, and then a 40-week safety follow-up.

Can I leave the study if I want to?

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