Autoimmune myositis – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Tue, 23 Jun 2026 04:07:52 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Autoimmune myositis – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Phase 2 Study of Daxdilimab with Prednisone in Adults with Inadequately Controlled Dermatomyositis or Anti‑Synthetase Inflammatory Myositis https://clinicaltrials.eu/trial/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 https://clinicaltrials.eu/trial/phase-2-study-of-daxdilimab-with-prednisone-in-adults-with-inadequately-controlled-dermatomyositis-or-anti-synthetase-inflammatory-myositis/ 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.

]]> A study to evaluate the safety and effectiveness of CABA-201, fludarabine, and cyclophosphamide in patients with active inflammatory myopathy https://clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-effectiveness-of-caba-201-fludarabine-and-cyclophosphamide-in-patients-with-active-inflammatory-myopathy/ Thu, 30 Apr 2026 13:08:56 +0000 https://clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-effectiveness-of-caba-201-fludarabine-and-cyclophosphamide-in-patients-with-active-inflammatory-myopathy/ This study focuses on individuals with active Idiopathic Inflammatory Myopathy, a group of rare diseases that cause muscle inflammation and weakness. This category includes conditions such as dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, and Juvenile Idiopathic Inflammatory Myopathy, which is a similar condition that occurs in children. Some participants may have previously been treated with medications such as cyclophosphamide or fludarabine.

The purpose of the study is to evaluate the safety and effectiveness of a treatment called CABA-201. This treatment is a type of CAR T-cell therapy, which involves using specially modified immune cells to target specific proteins on the surface of certain cells in the body. This medication is administered through an intravenous infusion, which is a method of delivering medicine directly into a vein.

During the study, participants will undergo regular monitoring to track how they respond to the treatment. This includes checking for any adverse events, which are unexpected or unwanted medical problems. Healthcare providers will also monitor levels of B cells, which are a type of white blood cell, and muscle enzymes in the blood to assess muscle health. Additionally, the levels of autoantibodies, which are proteins produced by the immune system that mistakenly attack the body’s own tissues, will be measured.

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