Necrotising myositis Trials in Disease

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

This clinical trial is studying whether patients with inflammatory muscle diseases can maintain stable health without needing intravenous immunoglobulin treatment. The study focuses on several related conditions, including immune-mediated necrotizing myopathy, polymyositis, dermatomyositis, antisynthetase syndrome, and overlap myositis.

Main inclusion criteria: Participants must be adults between 18 and 65 years old with a confirmed diagnosis of one of the inflammatory muscle diseases mentioned above. They must have been receiving IVIG treatment at a stable dose for at least 12 weeks before joining the study. Their disease must have been stable for at least 3 months, as determined by their doctor. Participants should also be on stable doses of other background medications, such as immunosuppressive drugs, antimalarials, or low-dose corticosteroids (up to 10 mg of prednisone daily) for at least 12 weeks. Women of childbearing potential must agree to use effective birth control methods during the study.

Main exclusion criteria: The trial does not accept participants who fall outside the specified age range or who are considered part of a vulnerable population requiring special protection. Patients must meet all the specific health and treatment stability criteria outlined in the inclusion requirements.

Focus and goal: The primary goal of this 20-week study is to determine whether patients can maintain stable disease activity without IVIG by week 16 when taking Upadacitinib. Participants will be randomly assigned to receive either Upadacitinib 30 mg or a placebo (an inactive substance) once daily. Neither the participants nor the researchers will know who receives which treatment. Throughout the study, doctors will closely monitor muscle strength, disease activity, quality of life, and any side effects. The study will also compare how long it takes for symptoms to worsen between those taking Upadacitinib and those taking the placebo. This research aims to provide valuable information about whether Upadacitinib could reduce or eliminate the need for IVIG treatment in managing these inflammatory muscle conditions.

Investigational drug: The study is testing Upadacitinib, also known by its code name ABT-494. This medication is taken by mouth once daily in the form of prolonged-release tablets, which means it releases the active ingredient slowly over time. Upadacitinib works by blocking certain enzymes called Janus kinases that play a role in inflammation and immune system activity. By inhibiting these enzymes, the medication aims to reduce inflammation and control the immune response that causes muscle damage in these conditions.