Ongoing Clinical Trials for Polymyositis
There are currently 7 clinical trials investigating new treatments for polymyositis, a rare inflammatory muscle disease. These studies are testing medications including anifrolumab, aldesleukin, dazukibart, CAR T cell therapy, upadacitinib, and enpatoran across multiple European countries. Most trials also include patients with dermatomyositis, a related condition.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis
- Study on the Effectiveness of Dazukibart in Adults with Active Dermatomyositis or Polymyositis
- Study on the Long-Term Safety of Dazukibart in Patients with Idiopathic Inflammatory Myopathies, Including Dermatomyositis and Polymyositis
- Czechia
- Denmark
- Espagne
- France
- Germany
- Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis
- Study on Low-Dose Aldesleukin for Patients with Pemphigus, Mucous Membrane Pemphigoid, Polymyositis, Dermatomyositis, and Primary Sclerosing Cholangitis
- Study on the Effectiveness of Dazukibart in Adults with Active Dermatomyositis or Polymyositis
- Study on the Safety of MB-CART19.1 for Patients with Active Systemic Lupus Erythematosus, Systemic Sclerosis, or Dermatomyositis/Polymyositis
- Greece
- Hungary
- Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis
- Study on the Effectiveness of Dazukibart in Adults with Active Dermatomyositis or Polymyositis
- Study on the Long-Term Safety of Dazukibart in Patients with Idiopathic Inflammatory Myopathies, Including Dermatomyositis and Polymyositis
- Italy
- Netherlands
- Poland
- Slovakia
- Spain
- Sweden
Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis
This trial is evaluating anifrolumab, a medication given as a subcutaneous injection, to see if it can improve disease activity when added to standard care.
Who can participate: Adults aged 18-75 years with a body weight between 40-100 kg who have a confirmed diagnosis of probable or definite polymyositis or dermatomyositis. Participants must have moderate or severe disease activity and be on a stable dose of oral prednisone or other treatments for their condition. Those with a history of active tuberculosis or severe COVID-19 cannot join.
Who cannot participate: People who do not meet the 2017 medical classification criteria for these conditions, those outside the specified age range, or those considered part of a vulnerable population are excluded from the study.
Main goal: The study aims to determine if anifrolumab can provide at least a moderate improvement in disease activity over 52 weeks. Participants will be randomly assigned to receive either anifrolumab or a placebo alongside their usual treatments. The trial follows a double-blind method, ensuring unbiased results.
Treatment being tested: Anifrolumab is a monoclonal antibody that works by targeting and blocking the type I interferon receptor, which plays a role in inflammation.
Study on Low-Dose Aldesleukin for Patients with Pemphigus, Mucous Membrane Pemphigoid, Polymyositis, Dermatomyositis, and Primary Sclerosing Cholangitis
This German trial investigates the safety and effectiveness of low-dose Interleukin-2 (IL-2), also known as aldesleukin, for several chronic inflammatory diseases including polymyositis and dermatomyositis.
Who can participate: Adults aged 18-80 years with polymyositis or dermatomyositis who have higher than normal levels of creatine kinase (between 300 and 3,000 units per liter). Having other rheumatic diseases at the same time is allowed. The trial also includes participants with other conditions such as pemphigus, mucous membrane pemphigoid, and primary sclerosing cholangitis, each with specific disease activity requirements.
Who cannot participate: Pregnant or breastfeeding individuals, people with severe allergic reactions to similar treatments, active infections requiring treatment, cancer within the last five years (except certain skin cancers), significant heart problems, uncontrolled high blood pressure, severe liver or kidney disease, recent use of investigational drugs, drug or alcohol abuse within the past year, and those unable to comply with study procedures are excluded.
Main goal: The study evaluates whether low-dose IL-2 therapy can safely increase regulatory T cells, which help control the immune system and reduce inflammation. The treatment is administered over eight weeks in a randomized, double-blind trial.
Treatment being tested: Low-dose IL-2 is an immunomodulatory agent that binds to specific receptors on T cells, promoting their growth and activity to help manage inflammation.
Study on the Effectiveness of Dazukibart in Adults with Active Dermatomyositis or Polymyositis
This international trial studies dazukibart (also known as PF-06823859), a protein-based medication designed to target and neutralize certain proteins involved in inflammation.
Who can participate: Adults aged 18 years or older with a confirmed diagnosis of definite or probable idiopathic inflammatory myopathy, including dermatomyositis or polymyositis. Participants must have active disease with specific muscle weakness scores and at least one abnormal assessment result. They must be on a stable dose of standard treatments such as oral corticosteroids or immunosuppressants.
Who cannot participate: People with other serious health conditions that could interfere with the study, recent infections requiring antibiotics, recent use of investigational drugs, history of allergic reactions to similar medications, drug or alcohol abuse, pregnant or breastfeeding women, and those unable to comply with study procedures.
Main goal: The study aims to determine if dazukibart can effectively reduce muscle symptoms in adults with active disease. Participants will be randomly assigned to receive either dazukibart through intravenous injection or a placebo, alongside their regular background medications. The trial lasts about one year with regular assessments of muscle symptoms and overall health.
Treatment being tested: Dazukibart is an experimental immunomodulatory agent that targets specific pathways involved in inflammation and immune response to improve muscle function.
Study on the Long-Term Safety of Dazukibart in Patients with Idiopathic Inflammatory Myopathies, Including Dermatomyositis and Polymyositis
This extension study examines the long-term safety and effects of dazukibart in people who completed a previous trial.
Who can participate: Adults with idiopathic inflammatory myopathy (including dermatomyositis or polymyositis) who completed the 52-week treatment period of the previous C0251006 study without early discontinuation. Both males and females are eligible.
Who cannot participate: People with serious health conditions that could interfere with the study, recent infections requiring antibiotics, recent investigational drug use, history of allergic reactions to similar medications, drug or alcohol abuse, pregnant or breastfeeding women, and those unable to comply with study procedures.
Main goal: The main objective is to evaluate the long-term safety and tolerability of dazukibart over an extended period, with the study estimated to conclude in November 2027. Regular monitoring will include assessments of muscle strength, disease activity, quality of life, and any adverse events.
Treatment being tested: Dazukibart is administered as an injection and works by modulating the immune system to reduce inflammation.
Study on the Safety of MB-CART19.1 for Patients with Active Systemic Lupus Erythematosus, Systemic Sclerosis, or Dermatomyositis/Polymyositis
This German study tests an innovative treatment called MB-CART19.1, which uses a patient’s own T-cells that have been modified to better target and fight autoimmune disease.
Who can participate: Adults aged 18 years or older with dermatomyositis or polymyositis who meet the 2017 classification criteria. Participants must have active muscle inflammation shown by biopsy or MRI, or signs of lung disease related to the condition. They must test positive for at least one specific myositis antibody, have muscle weakness, and meet at least two other criteria such as elevated muscle enzyme levels. Participants must not have responded well to or cannot tolerate glucocorticoids and at least two other standard treatments. The trial also includes participants with systemic lupus erythematosus and systemic sclerosis with their own specific criteria.
Who cannot participate: The exclusion criteria are not explicitly detailed beyond standard safety considerations for cell therapy trials.
Main goal: The study assesses the safety of this innovative CAR T cell therapy in patients with active autoimmune diseases. The modified T-cells are designed to express a chimeric antigen receptor directed against CD19, a protein found on certain immune cells. The treatment is administered through intravenous infusion, with close monitoring for side effects, particularly during the first four weeks.
Treatment being tested: MB-CART19.1 is an experimental form of immunotherapy that uses genetically modified T-cells to target and eliminate B cells contributing to autoimmune conditions.
Study on Upadacitinib for Patients with Idiopathic Inflammatory Myopathies After Stopping IVIG
This Austrian trial evaluates whether patients can maintain stable disease activity without intravenous immunoglobulins (IVIG) when taking upadacitinib.
Who can participate: Adults aged 18-65 years with a clinical diagnosis of idiopathic inflammatory myopathies including polymyositis, dermatomyositis, antisynthetase syndrome, overlap myositis, or immune-mediated necrotizing myopathy. Participants must have been receiving IVIG at a stable dose for at least 12 weeks and have stable disease activity for at least 3 months. They must also be on stable background treatments including immunosuppressive drugs, antimalarials, or low-dose corticosteroids for at least 12 weeks. Female participants must use effective birth control unless unable to have children.
Who cannot participate: The exclusion criteria focus on ensuring participants can safely withdraw from IVIG therapy and tolerate the study medication.
Main goal: The study aims to determine if patients can remain stable without IVIG by week 16 when taking upadacitinib. The trial lasts 20 weeks, with participants randomly assigned to receive either upadacitinib or a placebo in a double-blind fashion. Regular assessments monitor muscle strength, disease activity, and overall health.
Treatment being tested: Upadacitinib is a JAK inhibitor taken orally as prolonged-release tablets. It works by inhibiting Janus kinase enzymes involved in the inflammatory process, thereby reducing inflammation and immune response.
Study on the Effects of Enpatoran for Patients with Dermatomyositis and Polymyositis
This international study tests enpatoran, taken as a film-coated tablet, to evaluate its effectiveness and safety compared to placebo.
Who can participate: Adults with a diagnosis of probable or definite dermatomyositis or polymyositis according to specific medical guidelines, with positive tests for certain antibodies. Participants with anti-synthetase syndrome who meet the criteria can also join. They must have active disease while on standard treatment, shown by evidence of muscle inflammation from biopsy, electromyography, or MRI, or significantly elevated muscle enzyme levels, or active skin rash. Disease severity must be moderate to severe with specific muscle weakness scores and at least two additional criteria such as elevated patient or doctor activity ratings or disability scores. Participants must be on stable doses of oral corticosteroids and/or one other non-corticosteroid medication, and have a body mass index of 40.0 or less.
Who cannot participate: People with other serious health conditions, pregnant or breastfeeding women, recent infections requiring antibiotics, recent use of investigational drugs, history of severe allergic reactions, cancer within the past five years (except certain skin cancers), drug or alcohol abuse within the past year, recent live vaccines, uncontrolled heart conditions, and those unable to comply with study procedures.
Main goal: The study evaluates whether enpatoran can improve symptoms when used alongside usual treatments over 48 weeks. The trial is double-blind, with participants randomly assigned to receive either enpatoran or placebo. Regular check-ups include assessments of muscle strength, skin condition, and routine laboratory tests.
Treatment being tested: Enpatoran is an experimental immunomodulatory agent that helps regulate the immune system’s activity to reduce inflammation and potentially improve muscle strength and function.
Summary
The seven ongoing clinical trials for polymyositis represent a diverse range of therapeutic approaches, from monoclonal antibodies to cell therapy. Most trials also include patients with dermatomyositis, reflecting the clinical overlap between these conditions. Germany appears particularly active in research, hosting three different trials including the innovative CAR T cell therapy study. Several medications are in advanced testing phases, with dazukibart being evaluated in both efficacy and long-term safety studies. The trials are spread across 16 European countries, with particularly strong representation in Western and Central Europe. Most studies focus on patients who have not responded adequately to standard treatments, highlighting the need for new therapeutic options. The range of mechanisms being tested—from immune modulation to targeted antibody therapy—suggests researchers are exploring multiple pathways to address this challenging condition.
