Swedish Orphan Biovitrum AB (Sobi) has announced that the first patient has been randomised in the phase 3 study anaSTILLs, to evaluate efficacy and safety of anakinra in the treatment of Still’s disease.
The purpose of the study is to assess the efficacy and to evaluate the safety of anakinra in patients with newly diagnosed Still’s disease, including systemic juvenile idiopathic arthritis (SJIA) and adult onset Still’s disease (AOSD). The anaSTILLs study is a randomised, double-blind, multicentre study being conducted in North America studying two dose levels of anakinra, administrated subcutaneously, in comparison to placebo. In total 81 individuals are planned to be randomised in the study.
“We are very pleased with having initiated this confirmatory clinical study investigating the safety and efficacy of anakinra in people with Still’s disease. This is a disease affecting both young people and adults and is associated with a significant morbidity and with a large unmet medical need,” says Milan Zdravkovic, senior vice president, chief medical officer and head of Research & Development at Sobi.