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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the <b>double-blind placebo controlled period</b>

    The double-blind placebo controlled period begins upon joining the study. during this stage, the identity of the medication being taken is not known to you or the medical staff. you will receive either enpatoran, which is a 200 mg film-coated tablet taken by mouth, or a placebo, which is a pill that contains no active medicine.

    This period lasts for 24 weeks. throughout these 24 weeks, the effects of the medication on dermatomyositis or polymyositis (conditions involving muscle inflammation) are monitored using various clinical scores and measurements.

    Medical assessments will be performed at specific intervals, including weeks 4, 8, 12, 16, 20, and 24. these assessments track changes in muscle-associated enzymes (proteins found in the blood that indicate muscle health), skin activity scores, and other physical measures.

  2. Step 2

    Participation in the <b>open-label extension period</b>

    Following the initial 24-week period, there is an open-label extension period. in this phase, the treatment is no longer blinded, meaning the medication being used is known. the focus remains on monitoring safety and any side effects that may occur during continued use.

Who can join the trial?

7 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

Enpatoran - This medication is taken orally in the form of a film-coated tablet. It is currently an experimental drug being studied in clinical trials to treat rare inflammatory muscle diseases like dermatomyositis and polymyositis. As an immunotherapy agent, it works at the molecular level to calm down an overactive immune system that is mistakenly attacking the body's own muscles and skin.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501351-82-00Protocol codeMS200569_0041Estimated enrolment41 patientsSponsorMerck Healthcare KGaA

sourced from the EU Clinical Trials Register and site verification

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