A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients with Generalized Myasthenia Gravis (EMERGE)
Generalised myasthenia gravis is a rare, long-term condition where the immune system mistakenly attacks the communication points between nerves and muscles. This causes tiring muscle weakness that can affect vision, speaking, chewing, walking, and breathing. This Phase 3 clinical trial, called EMERGE, is looking at whether a new medicine called claseprubart (DNTH103) can help. Researchers want to know if it is safe and if it makes everyday tasks easier to manage compared to a placebo (an inactive dummy treatment). Adults aged 18 and over who have generalised myasthenia gravis may be able to take part. Participants will receive either the study medicine or a placebo, and doctors will carefully check their muscle strength and daily symptoms over at least 17 weeks. The results will help show if claseprubart is an effective new treatment option.
At a glance
What is this study about?
Myasthenia gravis is an autoimmune condition. Normally, your nerves send clear signals to your muscles so they can move properly. In people with generalised myasthenia gravis, the body's natural defences mistakenly block or damage these signals. As a result, muscles quickly become weak and tired, which can make simple everyday actions like smiling, swallowing, lifting your arms, or walking uphill feel exhausting.
The EMERGE study is a Phase 3 clinical trial. Phase 3 trials are the final major testing stage before a new medicine can be approved for general use. The medicine being tested is called claseprubart (or DNTH103). It is designed to calm down a specific part of the immune system that attacks the muscles, helping to restore normal strength and stamina.
Finding new treatments is very important because current therapies do not work well for everyone and can sometimes cause difficult side effects. By testing claseprubart against a placebo (a lookalike treatment with no active drug), researchers can be sure whether any improvements in muscle strength are truly caused by the new medicine.
Doctors will measure success using standard questionnaires and strength checks that show how well participants can carry out routine activities, such as brushing their teeth, eating, and climbing stairs, especially around the 17-week mark of treatment.
Key takeaways
- Tests a new medicine (claseprubart) for adults with generalised myasthenia gravis.
- Compares the study drug to a placebo to see if it reliably reduces muscle weakness.
- Primary checks focus on how well you can perform daily activities at 17 weeks.
- Participation includes regular clinic visits, muscle tests, and blood checks.
- Joining is completely voluntary, and you can withdraw at any point.
Who may be eligible?
To take part in this study, you must be an adult aged 18 or older and have a confirmed diagnosis of generalised myasthenia gravis. This means your muscle weakness affects more than just your eyes, extending to other areas such as your limbs, face, or breathing muscles.
The trial team will check that your symptoms are active enough to measure whether the medicine helps. You will also need to be able to attend regular hospital or clinic visits and complete simple surveys about how your illness affects your daily life.
You may not be able to join if you have other serious medical conditions that could make taking part unsafe, if you are currently taking certain other experimental drugs, or if you have recently had severe health complications. The study doctors will carefully review your full medical history to decide if the trial is a safe choice for you.
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.
- I am aged 18 or older.
- I have been diagnosed with generalised myasthenia gravis.
- My muscle weakness affects more than just my eye muscles.
- I am able and willing to attend regular hospital visits for tests and treatments.
- I am happy to talk through my medical history and current medicines with the trial team.
What does participation involve?
If you join the study, you will first have a screening visit where doctors check your health, blood, and medical history. If you are eligible, you will be randomly chosen (by chance, like flipping a coin) to receive either claseprubart or a placebo. Neither you nor your doctor will know which one you are receiving during this main phase, which keeps the test fair.
The initial part of the study lasts at least 17 weeks. During this time, you will visit the clinic regularly to receive the treatment, have blood tests, and undergo physical checks to measure your muscle strength. You will also fill out short questionnaires about your daily symptoms.
Later in the study, participants may have the option to join an extended phase where everyone receives the active medicine. The trial team will monitor your health closely throughout the study and for several weeks after your final dose.
Potential risks and benefits
Locations (11)
- —UnverifiedCzechia
- —UnverifiedPortugal
- —UnverifiedAustria
- —UnverifiedBulgaria
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedLatvia
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedDenmark
Common questions
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active drug. Researchers use it to see if the changes people experience are genuinely caused by the new medicine rather than other factors.
Can I choose whether I get the real medicine or the placebo?
No. A computer assigns you to a group by chance. This ensures the results are fair and reliable, although you may have access to the medicine later in an extension study.
Will taking part cost me anything?
No. The trial medicine, tests, and study visits are provided free of charge, and trial sponsors often help cover reasonable travel expenses to and from the hospital.
Can I carry on taking my usual medicines?
In many cases, yes, but the study doctor will review all your current treatments to make sure they are safe to use alongside the trial drug.
What happens if my symptoms get worse during the study?
Your safety comes first. The study doctors have clear rescue plans and can give you standard medicines if your symptoms flare up at any point.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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