Ongoing Clinical Trials for Dermatomyositis
Dermatomyositis is an inflammatory disease that causes muscle weakness and distinctive skin rashes. Currently, 15 clinical trials are testing new treatments for this condition across multiple countries in Europe and beyond. These studies are evaluating various medications, including immunomodulatory agents, JAK inhibitors, and antibody-based therapies, with the goal of improving symptoms and reducing the need for traditional corticosteroid treatments.
Clinical trial locations
- Austria
- Belgium
- 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 Effects of GLPG3667 for Adults with Dermatomyositis
- Study on the Effects of Human Normal Immunoglobulin in Adults with Dermatomyositis
- 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
- Study on the Effects of GLPG3667 for Adults with Dermatomyositis
- Croatia
- Czechia
- Denmark
- Espagne
- France
- Study of Sodium Thiosulfate Injections for Patients with Ectopic Calcifications or Ossifications from Dermatomyositis, Systemic Sclerosis, or iPPSD2
- Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis
- Study on Baricitinib for Patients with Relapsing or Naïve Dermatomyositis
- Study on the Effectiveness of Dazukibart in Adults with Active Dermatomyositis or Polymyositis
- Study on Baricitinib for Treating New-Onset Juvenile Dermatomyositis in Children
- Study on the Effects of GLPG3667 for Adults with Dermatomyositis
- Study on the Effects of Human Normal Immunoglobulin in Adults with Dermatomyositis
- 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
- Study on the Effects of GLPG3667 for Adults with Dermatomyositis
- Study on the Effects of Human Normal Immunoglobulin in Adults with Dermatomyositis
- Greece
Study of Sodium Thiosulfate Injections for Patients with Ectopic Calcifications or Ossifications from Dermatomyositis, Systemic Sclerosis, or iPPSD2
This trial, conducted in France, focuses on a specific complication that can occur in patients with the condition: abnormal calcium deposits or bone formations in the tissues, known as ectopic calcifications or ossifications. The study evaluates sodium thiosulfate injections given under the skin to see if they can reduce these deposits over a six-month treatment period.
Main inclusion criteria: Patients must be 18 years or older with ectopic calcification due to the condition, or have ectopic ossification due to iPPSD2 and be between 2 and 30 years old. The need for treatment must be confirmed by medical experts, and patients should not have planned surgery for the next 12 months. Women of childbearing age must use effective contraception.
Main exclusion criteria: Patients with conditions other than those specified in the trial, those outside the required age range, pregnant or breastfeeding women, individuals with allergies to the treatment, those currently in another trial, and patients with severe health issues or recent/planned surgeries are excluded.
Main focus: The trial assesses whether sodium thiosulfate can effectively reduce the volume of abnormal calcium or bone deposits. After a six-month observation period, patients receive six months of treatment with regular monitoring through CT scans. Changes in pain levels and quality of life are also evaluated.
Investigational drug: Sodium thiosulfate is a chelating agent that binds to minerals, helping dissolve calcium deposits. It is administered as a 10% solution injected under the skin directly at affected areas.
Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis
This international study, taking place in 13 European countries including Italy, France, Germany, and Spain, evaluates anifrolumab as an add-on treatment to standard care. The medication is administered through injections under the skin and is being compared to a placebo over 52 weeks.
Main inclusion criteria: Adults aged 18-75 years with a body weight between 40-100 kg must have a probable or definite diagnosis based on 2017 medical criteria. They should have moderate or severe disease activity and be on a stable dose of prednisone or other standard treatments. Participants must have no history of active tuberculosis or severe COVID-19.
Main exclusion criteria: Patients who don’t meet the 2017 classification criteria, those outside the specified age range, individuals not part of the designated trial groups, and vulnerable populations are excluded.
Main focus: The study examines whether anifrolumab can provide moderate improvement in disease activity over 52 weeks when added to standard care. It uses a double-blind method to ensure unbiased results.
Investigational drug: Anifrolumab is a monoclonal antibody that blocks the type I interferon receptor, which plays a role in inflammation. It is administered as a subcutaneous injection.
Study on Baricitinib for Patients with Relapsing or Naïve Dermatomyositis
This French trial studies baricitinib, a JAK1/2 inhibitor taken as a daily tablet, in patients who are either newly diagnosed or experiencing a relapse. The 24-week study aims to determine if patients can achieve improvement without needing prednisone.
Main inclusion criteria: Adults aged 18-64 years must have active disease, confirmed by tests showing muscle strength below certain thresholds or meeting specific assessment criteria. Those with relapsing disease must be on a stable dose of less than 30 mg daily of prednisone for at least 4 weeks, with or without other immunosuppressive medications that have been stable for 3 months.
Main exclusion criteria: Patients with conditions other than the specific types being studied, those outside the age range, individuals unable to stop prednisone use, and vulnerable populations are excluded.
Main focus: The trial evaluates whether patients can maintain stable disease activity without corticosteroids like prednisone. Assessments occur at weeks 5, 12, and 24, measuring muscle strength and skin condition improvements.
Investigational drug: Baricitinib is a JAK inhibitor that works by blocking enzymes involved in inflammation. It is taken orally as a prolonged-release tablet.
Study on Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
This Netherlands-based trial examines filgotinib, another JAK inhibitor, in patients with rare inflammatory diseases including idiopathic inflammatory myopathies. The medication is taken orally as film-coated tablets for up to 26 weeks.
Main inclusion criteria: Patients must be 18 or older with refractory disease, meaning symptoms persist despite 12 weeks of corticosteroid therapy and failure to respond to at least one other standard medication. They must have no evidence of active or latent tuberculosis. For idiopathic inflammatory myopathy, active disease must be shown by specific scores or test results.
Main exclusion criteria: Patients with active infections, history of serious allergic reactions to similar medications, severe heart, liver, or kidney disease, uncontrolled high blood pressure, cancer within the last 5 years, pregnancy or breastfeeding, and participation in another trial within 30 days are excluded.
Main focus: The study assesses how filgotinib affects quality of life, disease activity, and safety in patients who haven’t responded to other treatments. Regular monitoring includes assessments of symptoms and overall wellbeing.
Investigational drug: Filgotinib is a JAK inhibitor that blocks specific enzymes involved in the immune response, helping to reduce inflammation. It is taken orally in doses of either 100 mg or 200 mg.
Study on Low-Dose Aldesleukin for Patients with Pemphigus, Mucous Membrane Pemphigoid, Polymyositis, Dermatomyositis, and Primary Sclerosing Cholangitis
This German study evaluates low-dose interleukin-2 (also called aldesleukin) for several chronic inflammatory diseases including polymyositis and the condition being discussed. The treatment is given as an injection under the skin over eight weeks.
Main inclusion criteria: Participants must be 18-80 years old with one of the specified conditions. For polymyositis or the condition in question, they should have higher than normal levels of the muscle enzyme creatine kinase (between 300-3000 units per liter), and having other rheumatic diseases is allowed.
Main exclusion criteria: Pregnant or breastfeeding women, individuals 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, and those unable to comply with procedures are excluded.
Main focus: The trial evaluates the safety and the relationship between immune response and clinical outcomes when using low-dose IL-2 therapy. It examines whether the treatment can safely increase regulatory T cells, which help control inflammation.
Investigational drug: Aldesleukin (interleukin-2) is an immunomodulatory agent that promotes the growth and activity of specific T cells by binding to receptors on these cells.
Study on the Effectiveness of Dazukibart in Adults with Active Dermatomyositis or Polymyositis
This large international trial spans 11 European countries including France, Spain, Germany, and Poland. It studies dazukibart (also known as PF-06823859), a protein-based medication given through intravenous injection, compared to placebo over approximately one year.
Main inclusion criteria: Adults 18 years or older must have a confirmed diagnosis of active idiopathic inflammatory myopathies. They should show specific muscle weakness patterns measured by standardized tests and be on a stable dose of background medications, which may include oral corticosteroids or immunosuppressants.
Main exclusion criteria: Participants with other serious health conditions, recent infections requiring antibiotics, participation in another investigational drug trial within 30 days, history of allergic reactions to similar medications, and drug or alcohol abuse are excluded.
Main focus: The study determines if dazukibart can effectively reduce muscle symptoms in adults with active disease. Participants are randomly assigned to receive either the medication or placebo, with regular follow-up assessments to monitor muscle strength and overall health.
Investigational drug: Dazukibart is administered intravenously and works by targeting and neutralizing certain proteins involved in inflammation. It is classified as an immunomodulatory agent.
Study on the Long-Term Safety of Dazukibart in Patients with Idiopathic Inflammatory Myopathies, Including Dermatomyositis and Polymyositis
This extension study in Hungary and Bulgaria follows patients who completed the previous dazukibart trial, evaluating the long-term safety and effects of the medication for up to 52 additional weeks.
Main inclusion criteria: Participants must have completed the 52-week treatment period in the previous C0251006 study without stopping early. Both males and females with idiopathic inflammatory myopathy are eligible.
Main exclusion criteria: Participants with other serious health conditions, recent infections requiring antibiotics, participation in another drug trial within 30 days, history of allergic reactions to similar medications, and drug or alcohol abuse are excluded.
Main focus: The study evaluates the long-term safety, tolerability, and effectiveness of dazukibart. Regular monitoring includes assessments of muscle strength, disease activity, and quality of life measures.
Investigational drug: Dazukibart is administered as an injection and works by modulating the immune system to reduce inflammation. It is classified as an immunomodulatory agent still under investigation.
Study on the Safety of MB-CART19.1 for Patients with Active Systemic Lupus Erythematosus, Systemic Sclerosis, or Dermatomyositis/Polymyositis
This German trial studies an innovative cell-based therapy called MB-CART19.1 for several autoimmune diseases. The treatment uses patients’ own T-cells that have been modified in a laboratory to better target disease-causing cells.
Main inclusion criteria: Adults 18 or older must have a diagnosis according to specific 2017 guidelines. They must show active disease with moderate or severe symptoms based on standardized assessments. Patients should have failed or been intolerant to at least two standard treatments and be on stable doses of allowed medications.
Main exclusion criteria: Patients with specific muscle diseases, those outside the age range, individuals not meeting other criteria, and vulnerable populations are excluded.
Main focus: The study assesses the safety of this CAR T cell therapy in patients with active autoimmune diseases. It monitors for potential side effects, particularly cytokine release syndrome and neurotoxicity in the first weeks after treatment.
Investigational drug: MB-CART19.1 is an anti-CD19 CAR T cell therapy administered through intravenous infusion. The modified cells target and eliminate B cells that contribute to autoimmune conditions.
Study on Upadacitinib for Patients with Idiopathic Inflammatory Myopathies After Stopping IVIG
This Austrian trial evaluates upadacitinib, taken as a once-daily oral tablet, in patients who have been dependent on intravenous immunoglobulins (IVIG) for disease control. The 20-week study examines whether patients can maintain stability without IVIG.
Main inclusion criteria: Adults aged 18-65 years must have a clinical diagnosis of idiopathic inflammatory myopathies including polymyositis, the condition in focus, antisynthetase syndrome, overlap myositis, or immune-mediated necrotizing myopathy. They must have been receiving stable IVIG treatment for at least 12 weeks with stable disease activity for 3 months.
Main exclusion criteria: Patients with specific muscle diseases not included in the study, those outside the age range, individuals unable to follow study procedures, and vulnerable populations are excluded.
Main focus: The trial determines if patients can maintain stable disease activity without IVIG by week 16 when taking upadacitinib. Secondary outcomes include differences in muscle strength and patient-reported outcomes.
Investigational drug: Upadacitinib is a JAK inhibitor that reduces inflammation by blocking specific enzymes involved in the inflammatory process. It is taken orally as a prolonged-release tablet.
Study on the Safety and Effectiveness of Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
This Netherlands-based trial is similar to the earlier filgotinib study but focuses more specifically on safety and effectiveness data for up to 26 weeks. It examines patients whose symptoms have not improved with standard treatments.
Main inclusion criteria: Patients 18 or older must have refractory disease, meaning symptoms continue despite 12 weeks of corticosteroid therapy and failure to respond to standard medications. For idiopathic inflammatory myopathy, active disease must be demonstrated by specific scores or abnormal enzyme levels.
Main exclusion criteria: Active infections, serious allergic reactions to similar medications, severe liver or kidney disease, uncontrolled high blood pressure, certain cancers, pregnancy or breastfeeding, and participation in another trial within 30 days are excluded.
Main focus: The study examines the safety and effectiveness of filgotinib in reducing inflammation and improving symptoms. Regular monitoring includes physical examinations, blood tests, and questionnaires about symptoms and quality of life.
Investigational drug: Filgotinib is a JAK inhibitor available in 100 mg and 200 mg doses. It works by inhibiting proteins that play a key role in inflammation.
Summary
The 15 ongoing clinical trials for this condition demonstrate significant research activity across Europe, with France and Germany hosting the most studies. The trials span a diverse range of therapeutic approaches, from traditional immunomodulatory agents to innovative cell-based therapies.
Several trials focus on JAK inhibitors, including baricitinib, filgotinib, and upadacitinib, reflecting growing interest in this class of medications. Multiple studies evaluate monoclonal antibodies such as anifrolumab, dazukibart, and empasiprubart. Notably, some trials address specific complications like ectopic calcifications, while others explore whether patients can reduce dependence on corticosteroids or IVIG.
The international nature of many studies, particularly those spanning multiple European countries, suggests a coordinated effort to gather robust data. France appears particularly active with seven trials, followed by Germany, Spain, and Italy. The variety of medications being tested offers hope for expanded treatment options, especially for patients who have not responded to standard therapies.
