Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants receiving Standard of Care

This clinical trial is looking at a new medication called Enpatoran for people with dermatomyositis and polymyositis. Participants will either receive Enpatoran or a placebo (a dummy drug) in addition to their usual care. This is a "Phase II" study, meaning it's still relatively early-stage research focusing on whether the new drug works and if it's safe. Researchers will carefully check symptoms, side effects, and changes in health using blood tests and other examinations over 24 weeks. The goal is to find out if Enpatoran can improve the overall condition and quality of life for people with these muscle diseases, while making sure it doesn't cause too many problems.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Healthcare KGaA

Enrolment target

Start

20 Apr 2023

Dermatomyositis Polymyositis

What is this study about?

This study is about a new medicine called Enpatoran, which is being tested for two conditions: dermatomyositis and polymyositis. Both are rare diseases that cause muscle weakness and pain. Dermatomyositis can also affect the skin, causing rashes. The aim of this research is to see if Enpatoran can help people with these conditions feel better and improve their symptoms when given alongside their regular treatment.

Participants in the study will be randomly assigned to one of two groups: one group will receive Enpatoran, and the other will receive a placebo. A placebo looks like the real medicine but doesn't contain any active drug. This is done so researchers can fairly compare the effects of Enpatoran against no active treatment, without anyone knowing who is getting what. This helps ensure the results are trustworthy.

Researchers will closely monitor how participants' conditions change over 24 weeks. They will look at how symptoms improve, check for any side effects, and examine various health markers like blood test results and heart activity. This study is an important step in understanding if Enpatoran could be a future treatment option for dermatomyositis and polymyositis.

Key takeaways

A study for dermatomyositis and polymyositis.
Testing a new drug called Enpatoran against a placebo.
Part of an ongoing research process (Phase II).
Looks at if Enpatoran improves symptoms and is safe.
Close monitoring of health over 24 weeks.
Participants continue their standard treatment.

Who may be eligible?

To join this study, you must be at least 18 years old. People of any gender can take part.

More specific details about your health and medical history would be considered by the study doctors to determine if you are a good fit for the trial. This is to make sure the study is safe for you and that the results will be clear.

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 diagnosis of dermatomyositis or polymyositis?
Are you able to attend regular appointments for 24 weeks?
Are you currently receiving standard care for your condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to either receive Enpatoran or a placebo, along with your usual medication. It's a "double-blind" study, meaning neither you nor your study doctor will know which one you're getting. You'll have regular hospital visits over 24 weeks for health checks, blood tests, and other examinations like ECGs (heart tests). Doctors will assess your symptoms and overall condition. After this initial period, there might be an option to continue into an "open-label extension" phase, where everyone receives the active drug and the monitoring continues. The study aims to understand how the drug works and its safety over time.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research and potentially receiving a new treatment that could help improve your condition. However, there's no guarantee you will personally benefit, especially if you receive the placebo. Potential risks could include side effects from the study drug, which will be carefully monitored. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (6)

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

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Unverified
Italy
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Unverified
Poland
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Unverified
Czechia
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Unverified
Sweden
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Unverified
Spain
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Unverified
Greece

Common questions

What are dermatomyositis and polymyositis?

They are rare diseases that cause muscle weakness and pain, and dermatomyositis can also cause skin rashes.

What is Enpatoran?

It's a new medicine being tested to see if it can help improve symptoms of dermatomyositis and polymyositis.

What does 'placebo' mean?

A placebo is a 'dummy' drug that looks like the real medicine but doesn't contain any active ingredients.

How long will the main part of the study last?

The main part of the study will last for 24 weeks, which is about 6 months.

Can I stop participating if I want to?

Yes, you can leave the study at any time without it affecting your usual medical care.