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Study on the Effects of Enpatoran for Patients with Dermatomyositis and Polymyositis

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What is this study about?

This clinical trial is focused on studying two diseases: Dermatomyositis and Polymyositis. These are conditions that cause muscle weakness and skin rashes. The trial will test a new treatment called Enpatoran, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective and safe Enpatoran is for people with these conditions, compared to a placebo. Participants will continue to receive their usual care while taking part in the study.

The study will be conducted over a period of 48 weeks. During this time, participants will be randomly assigned to receive either Enpatoran or a placebo. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The main focus will be on the improvement of symptoms and the safety of the treatment.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. These check-ups will include assessments of muscle strength and skin condition, as well as routine laboratory tests to ensure the safety of the treatment. The study aims to provide valuable information on whether Enpatoran can be a beneficial treatment option for those living with Dermatomyositis and Polymyositis.

Who Can Join the Study?

  • You must have a diagnosis of dermatomyositis or polymyositis, which are inflammatory diseases that cause muscle weakness and sometimes skin rashes, and you must have positive autoantibodies, which are proteins in the blood that mistakenly attack the body’s own tissues.
  • People with anti-synthetase syndrome, a specific type of these inflammatory diseases, are also allowed to join if they meet the diagnosis rules.
  • Your disease must be active, meaning it is currently causing symptoms. This must be proven by one of the following within the last 6 months: a muscle biopsy (taking a small piece of muscle to look at under a microscope), an electromyography (a test that measures electrical activity in muscles), an MRI (a medical imaging scan), or having muscle enzymes (proteins released when muscles are damaged) that are at least 4 times higher than the normal limit.
  • If you have dermatomyositis, you may also need to have an active skin rash that meets a specific severity score.
  • Your disease must be at least moderately severe, which is measured by muscle strength testing and specific scores regarding how the disease affects your daily life, your doctor’s assessment, or your physical abilities.
  • You must be taking a stable dose of corticosteroids (steroid medications used to reduce inflammation) and/or a maximum of one other immunosuppressant (a medication that lowers the activity of your immune system).
  • Your body mass index (a measure of body fat based on your height and weight) must be 40.0 or lower.

Who Cannot Join the Study?

  • People diagnosed with inclusion body myositis, which is a specific type of muscle inflammation.
  • People with malignancy-associated myositis, which means muscle inflammation that occurred within 3 years of having cancer (uncontrolled cell growth).
  • People with immune mediated necrotizing myopathy (IMNM), a condition where the body’s immune system attacks muscle cells, causing them to die, especially if they test positive for specific antibodies (proteins that help the immune system identify foreign objects).
  • People with certain antibodies, such as anti-TIF1 gamma or anti-MDA5, must have had a recent and complete cancer screening (medical tests to check for cancer) within the last year.
  • People diagnosed with juvenile dermatomyositis, which is a version of the disease that typically starts in childhood, or adults who had it as children.
  • People with other active connective tissue diseases, which are conditions affecting the tissues that support the body, that are linked to muscle inflammation.
  • People with severe interstitial lung disease, a condition where scarring affects the lungs, specifically if they need extra oxygen while resting or if their forced vital capacity (FVC)—a measure of how much air the lungs can hold—is below 60 percent of what is expected.
  • People with anti-MDA5 antibodies who have not had a high resolution computed tomography (HRCT), which is a detailed type of X-ray scan, to check their lungs within the last year.
  • People with any uncontrolled diseases that could make the study unsafe, such as severe problems with breathing, the heart, digestion, nerves, mental health, blood, metabolism (including thyroid issues), kidneys, liver, or reproductive organs.
  • People with renal disease (kidney problems) where the estimated glomerular filtration rate (eGFR)—a measure of how well the kidneys filter blood—is less than 40 milliliters per minute.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Hippokration Hospital Athens Greece
General University Hospital Of Larissa Larissa Greece
Karolinska University Hospital Solna Sweden
Azienda USL Toscana Centro Florence Italy
Revmatologicky Ustav Prague Czechia
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Nvxtnbqu Ayq Kymxkmtmmalz Ulhgcwntea Oy Akumis Athens Greece
Aqudeuu Uwd Iyglp Di Rxdnbg Eljgyp Reggio Emilia Italy
Hwgsfjzd Vljq dofaxmre Barcelona Spain
Hbgmuzeb Uehbqmqxmwdrn dv A Cwqali A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
18.04.2023
Greece Greece
Not recruiting
18.04.2023
Italy Italy
Not recruiting
18.04.2023
Poland Poland
Not recruiting
18.04.2023
Spain Spain
Not recruiting
18.04.2023
Sweden Sweden
Not recruiting
18.04.2023

Trial locations

Investigated drugs:

Enpatoran is an experimental medication taken by mouth as a tablet. In this study, it is being tested to see if it can help improve symptoms and ensure safety for people living with dermatomyositis and polymyositis.

Investigated diseases:

Dermatomyositis – This is an inflammatory disease that causes muscle weakness and a distinctive skin rash. The condition typically begins with a reddish or purplish rash on the face, eyelids, knuckles, or other skin areas. It often progresses to involve inflammation of the muscles, leading to difficulty performing daily physical tasks. The skin changes and muscle weakness can fluctuate in severity over time.

Polymyositis – This is an inflammatory disease characterized by muscle weakness that occurs in various muscle groups throughout the body. Unlike some other conditions, it primarily affects the muscles rather than the skin. The weakness usually develops gradually and is most noticeable in the muscles closest to the trunk, such as the hips and shoulders. As the condition progresses, it can make movements like rising from a chair or climbing stairs increasingly difficult.

Trial ID:
2022-501351-82-00
Protocol code:
MS200569_0041
NCT ID:
NCT05650567
Trial Phase:
Therapeutic exploratory (Phase II)

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