Antisynthetase syndrome – European Clinical Trials Information Network

Phase 2 Study of Daxdilimab with Prednisone in Adults with Inadequately Controlled Dermatomyositis or Anti‑Synthetase Inflammatory Myositis

Fri, 19 Jun 2026 04:03:40 +0000

The study focuses on two rare muscle‑inflammatory conditions, Dermatomyositis and anti‑synthetase inflammatory myositis. Both diseases cause muscle weakness and skin rashes because the immune system mistakenly attacks muscle and skin tissue. Participants will receive a subcutaneous injection, which means the medicine is given just under the skin, of the experimental drug daxdilimab. In addition, they will continue their usual oral steroid medication, prednisone, which helps control inflammation.

The purpose of the trial is to determine whether the experimental drug can lower disease activity compared with a placebo. Adults will be randomly assigned to receive either the study drug or the placebo, and neither the participants nor the study staff will know which treatment is given. Injections will be given at regular intervals over about six months, with clinic visits to assess muscle strength, skin involvement, and any side effects. Researchers will track changes using simple scores that measure overall improvement and skin disease activity, and they will also monitor whether participants can reduce their steroid dose safely.

Study on Upadacitinib for Patients with Idiopathic Inflammatory Myopathies After Stopping IVIG

Wed, 29 Apr 2026 14:58:28 +0000

This clinical trial is focused on studying a group of diseases known as idiopathic inflammatory myopathies. These diseases include polymyositis, dermatomyositis, antisynthetase syndrome, overlap myositis, and immune-mediated necrotizing myopathy. These conditions are characterized by inflammation of the muscles, which can lead to muscle weakness and other symptoms. The trial will evaluate the effectiveness and safety of a medication called Upadacitinib, also known by its code name ABT-494. This medication is taken orally in the form of prolonged-release tablets, which means it is designed to release the active ingredient slowly over time.

The purpose of the study is to assess whether patients can maintain stable disease activity without the need for intravenous immunoglobulins (IVIG), a common treatment for these conditions. Participants in the study will be randomly assigned to receive either Upadacitinib or a placebo, which is a substance with no active medication. The study will last for a period of 20 weeks, during which the participants’ health and disease activity will be closely monitored. The main goal is to see if patients can remain stable without IVIG by the 16th week of the study.

Throughout the trial, various aspects of the participants’ health will be evaluated, including muscle strength, quality of life, and any side effects experienced. The study will also compare the time it takes for symptoms to worsen between those taking Upadacitinib and those taking the placebo. This research aims to provide valuable insights into the potential of Upadacitinib as a treatment option for individuals with idiopathic inflammatory myopathies, potentially reducing the need for IVIG and improving overall management of these conditions.

Study on Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease

Wed, 29 Apr 2026 14:25:38 +0000

This clinical trial is focused on studying the effects of a medication called filgotinib on certain rare diseases. The diseases being studied are Idiopathic Inflammatory Myopathies, Behçet’s Disease, and IgG4-related Disease. These are conditions where the immune system mistakenly attacks the body’s own tissues, leading to inflammation and other symptoms. The medication filgotinib is taken in the form of film-coated tablets and is known as a JAK-inhibitor, which means it works by blocking certain enzymes in the body that are involved in the immune response.

The purpose of this study is to see how filgotinib affects the quality of life, disease activity, and safety in patients who have these conditions and have not responded well to other treatments. Participants in the study will receive either filgotinib or a placebo, and their progress will be monitored over a period of time. The study will look at various aspects of the diseases, such as the number of oral ulcers, skin disease severity, and overall disease activity, to determine how well the treatment is working.

Throughout the study, participants will be asked to complete forms and assessments to help researchers understand the impact of the treatment on their symptoms and daily life. The study aims to provide valuable information on the potential benefits and safety of using filgotinib for these rare immune-mediated inflammatory diseases. The results could lead to improved treatment options for patients with these challenging conditions.

Study on the Safety and Effectiveness of Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease

Wed, 29 Apr 2026 14:24:11 +0000

This clinical trial is focused on studying the effects of a medication called filgotinib on certain rare diseases that involve inflammation caused by the immune system. The diseases being studied are Idiopathic Inflammatory Myopathies, Behçet’s disease, and IgG4-related disease. These conditions are characterized by the body’s immune system mistakenly attacking its own tissues, leading to inflammation and various symptoms. The medication being tested, filgotinib, is a type of drug known as a JAK-inhibitor, which works by blocking specific pathways in the immune system that contribute to inflammation.

The purpose of this study is to examine the safety and effectiveness of filgotinib in patients whose symptoms have not improved with standard treatments. Participants in the study will receive either Jyseleca 100 mg or Jyseleca 200 mg film-coated tablets, which contain the active substance filgotinib. The study will last for a period of up to 26 weeks, during which participants will take the medication orally. Some participants may receive a placebo instead of the active medication. Throughout the study, participants will be monitored to assess how well the medication is working and to check for any side effects.

By participating in this study, researchers hope to gather valuable information about the potential benefits and risks of using filgotinib for treating these rare inflammatory diseases. The findings from this study could help improve treatment options for patients with these conditions in the future.