Ongoing Clinical Trials for Antisynthetase Syndrome
There are currently 3 ongoing clinical trials investigating treatments for antisynthetase syndrome, focusing primarily on JAK inhibitor medications. These studies are being conducted in the Netherlands and Austria, evaluating the effectiveness of filgotinib and upadacitinib in patients whose condition has not responded well to standard treatments.
Clinical trial locations
- Austria
- Netherlands
Study on Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
This trial is evaluating filgotinib, a JAK inhibitor medication, for patients with inflammatory conditions including antisynthetase syndrome. The study aims to determine how this treatment affects quality of life, disease activity, and overall safety in patients who have not responded well to other therapies.
Main inclusion criteria: Participants must be at least 18 years old and have refractory disease, meaning their condition continues to show symptoms despite 12 weeks of corticosteroid therapy and at least one other standard medication such as methotrexate, mycophenolate mofetil, azathioprine, or rituximab. Patients must have no evidence of active or latent tuberculosis, confirmed through specific blood tests and chest X-rays. For patients with idiopathic inflammatory myopathy, active disease must be demonstrated through elevated muscle enzyme levels, MRI evidence of muscle inflammation, or clinical judgment indicating need for additional treatment.
Main exclusion criteria: Patients with active, uncontrolled infections cannot participate. Those who have had serious allergic reactions to similar medications, severe heart problems, uncontrolled high blood pressure, or unstable liver or kidney disease are excluded. Pregnant or breastfeeding women are not eligible, nor are those who participated in another clinical trial within the last 30 days. Patients with a history of cancer in the last 5 years or uncontrolled mental health conditions are also excluded.
Trial focus: The study monitors patients taking filgotinib tablets daily for up to 26 weeks. Participants complete regular assessments and forms to track their symptoms and response to treatment. The research team evaluates various aspects of the disease, including overall disease activity and impact on daily life.
Investigational drug: Filgotinib is an oral JAK inhibitor that works by blocking certain enzymes in the body involved in the inflammatory response. By reducing inflammation, it may help decrease symptoms such as pain and swelling in conditions where the immune system attacks the body’s own tissues.
Study on Upadacitinib for Patients with Idiopathic Inflammatory Myopathies After Stopping IVIG
This trial is investigating whether patients with idiopathic inflammatory myopathies, including antisynthetase syndrome, can maintain stable disease without needing intravenous immunoglobulin treatment when taking upadacitinib. The study runs for 20 weeks and compares the medication against a placebo.
Main inclusion criteria: Patients must be between 18 and 65 years old with a clinical diagnosis of idiopathic inflammatory myopathy, including antisynthetase syndrome. They must be receiving IVIG at a stable dose for at least 12 weeks before the study begins and have maintained stable disease activity for at least 3 months according to their doctor’s judgment. Participants must also be on stable doses of allowed background treatments, such as immunosuppressive drugs, antimalarials, or low-dose corticosteroids, for at least 12 weeks. Female participants of childbearing potential must agree to use effective birth control methods.
Main exclusion criteria: The trial excludes patients outside the specified age range. Both males and females are eligible, but those who do not meet other specific criteria may be excluded. Patients considered part of a vulnerable population requiring special protection or care are not included.
Trial focus: Participants are randomly assigned to receive either upadacitinib 30 mg or placebo once daily for up to 16 weeks. The main goal is to determine whether patients can maintain stable disease activity without IVIG by week 16. Throughout the trial, researchers monitor muscle strength, disease activity, quality of life, and any side effects. Follow-up continues until week 20 to assess long-term effects.
Investigational drug: Upadacitinib is a JAK inhibitor administered as a prolonged-release tablet taken once daily. It works by blocking Janus kinase enzymes involved in the inflammatory process, thereby reducing inflammation and immune response.
Study on the Safety and Effectiveness of Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
This study examines the safety and effectiveness of filgotinib in patients with rare inflammatory diseases, including antisynthetase syndrome, whose symptoms have not improved with standard treatments. The trial lasts up to 26 weeks.
Main inclusion criteria: Participants must be at least 18 years old with refractory disease that continues despite 12 weeks of corticosteroid treatment and failure to respond to at least prednisone and one other medication, or inability to tolerate standard treatments. Patients must have no evidence of active or latent tuberculosis, confirmed through blood tests and chest X-rays. For those with idiopathic inflammatory myopathy, active disease must be demonstrated through specific scoring systems, abnormal enzyme levels, MRI evidence of muscle inflammation, or clinical need for new or additional medication.
Main exclusion criteria: Patients with active, uncontrolled infections, serious allergic reactions to similar medications, severe liver disease, uncontrolled high blood pressure, or certain types of cancer are excluded. Those who are pregnant, breastfeeding, or participated in another clinical trial within 30 days cannot join. Patients with severe heart or kidney disease, or autoimmune diseases other than those being studied, are also not eligible.
Trial focus: The study involves taking filgotinib tablets orally, available in two dosages: 100 mg and 200 mg. Participants attend regular follow-up visits for physical examinations, blood tests, and completion of questionnaires to evaluate symptoms and overall well-being. At the study’s end, a comprehensive evaluation assesses any health changes during the trial.
Investigational drug: Filgotinib blocks specific proteins in the body involved in causing inflammation. By reducing inflammation, it may help alleviate symptoms like pain and swelling in conditions that are difficult to treat with other medications.
Summary
All three ongoing clinical trials for antisynthetase syndrome focus on JAK inhibitor medications as potential treatments. Two trials are investigating filgotinib and one is studying upadacitinib. The Netherlands hosts two of the three studies, while Austria hosts one. These trials specifically target patients whose condition has not responded adequately to conventional treatments, representing an important research focus for refractory cases. The studies examine whether these medications can maintain disease stability, improve quality of life, and reduce dependence on treatments like intravenous immunoglobulins. All trials require careful screening for tuberculosis and exclude patients with active infections or certain serious health conditions.
