Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With Dermatomyositis

This study is a research project for adults who have dermatomyositis, a condition that causes muscle weakness and skin problems. Researchers want to see if a new medicine, empasiprubart, is safe, how well people tolerate it, and how effective it is in treating the condition. Participants will be randomly assigned to either receive the new medicine or a placebo (a treatment with no active drug) without knowing which one they are getting. This helps scientists fairly compare the effects of the new medicine. The study will mainly look at any side effects people experience and whether they need to stop taking the medicine because of side effects. It will also track how much people's dermatomyositis symptoms improve over time. The study will involve regular check-ups over an extended period.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Argenx

Enrolment target

Start

13 Nov 2024

Myositis Dermatomyositis

What is this study about?

This research study is focused on a health condition called dermatomyositis. Dermatomyositis is a rare disease that causes inflammation in your muscles, leading to muscle weakness, and often affects your skin, causing rashes. It can make everyday activities like climbing stairs or getting dressed quite challenging. Living with dermatomyositis can be difficult, and doctors are always looking for better ways to manage the symptoms and improve the lives of people affected.

The main goal of this study is to explore a new potential medicine called empasiprubart. Researchers want to understand if this medicine is a safe and helpful treatment for adults with dermatomyositis. They are particularly interested in seeing what side effects, if any, people experience when taking it, and how well their bodies cope with the treatment. Importantly, the study also aims to figure out if empasiprubart can actually make a difference to the symptoms of dermatomyositis, helping people feel better and improve their condition.

To make sure the study results are as fair and accurate as possible, some participants will receive the new medicine, while others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active drug. Neither the participants nor the doctors will know who is getting which treatment. This is like a 'blind' test, and it helps the researchers measure the true effects of the new medicine without any bias. By carefully comparing the experiences of both groups, scientists hope to learn if empasiprubart could be a valuable new option for people living with dermatomyositis.

Key takeaways

This study is testing a new medicine for dermatomyositis.
It aims to check the safety, how people tolerate it, and if it improves symptoms.
Participants will receive either the new medicine or a dummy treatment (placebo).
Both men and women aged 18 and over with dermatomyositis can take part.
The study involves regular clinic visits for treatment and health check-ups.
Your health will be monitored for up to 90 weeks, with main treatment lasting about 25 weeks.

Who may be eligible?

To be able to take part in this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning people of all adult ages can be considered.

Both men and women are welcome to participate in this research. The study aims to understand how the new medicine affects a wide range of people with dermatomyositis.

Beyond these basic age and sex requirements, there will be other specific medical criteria that your doctor and the study team will need to check to make sure the study is right for you and that you can safely take part. These might include how serious your dermatomyositis is, what other medicines you are taking, and your general health.

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?
Have you been diagnosed with dermatomyositis?
Are you able to attend regular clinic appointments for treatment and check-ups?
Are you willing to potentially receive either the new study medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be given either the new medicine, empasiprubart, or a placebo (a dummy treatment) through a drip into your arm (intravenously). You won't know which one you're getting. You'll need to have regular visits to the clinic for this treatment and for check-ups.

During your visits, the study team will carry out various assessments. These will include checking for any side effects you might be having, taking blood or urine samples, and thoroughly checking your physical health. They will also assess how your dermatomyositis symptoms are changing and how you are feeling overall.

The initial part of the study where you receive the main treatment will last for about 25 weeks. However, the study will continue to monitor your health and any side effects for a longer period, up to 90 weeks, to ensure long-term safety and observe any lasting effects. You'll have scheduled appointments throughout this entire period.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. You might feel better if the new medicine works, and you'll be contributing important information to medical science that could help others with dermatomyositis in the future. However, there's a chance you might experience side effects from the medicine, or the placebo might not improve your condition. Researchers will carefully monitor you for any problems. Remember, joining this study is completely your choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Greece
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Unverified
Poland
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Unverified
Italy
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Unverified
Spain

Common questions

What is dermatomyositis?

Dermatomyositis is a disease that causes tired muscles and skin rashes on different parts of your body.

What is a 'placebo'?

A placebo is a substance that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers fairly compare how well the new medicine works.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know if you are receiving the active medicine or the placebo. This is called 'double-blinded' and helps ensure fair results.

How long will I be in the study?

The main treatment part of the study will last for about 25 weeks, but the researchers will continue to check on your health and side effects for up to 90 weeks in total.

Can I leave the study if I change my mind?

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