In short
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 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.
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.
