Swedish Orphan Biovitrum (Sobi) has started patient enrolment in the Phase III anaSTILLs clinical trial of Kineret (anakinra) for Still’s disease treatment.
Still’s disease is an auto-inflammatory disorder, while Kineret is an antagonist of interleukin-1 receptor and is indicated for minimising signs and symptoms of rheumatoid arthritis (RA).
The multi-centre, randomised, double-blind anaSTILLs trial will investigate the safety and efficacy of anakinra in newly diagnosed patients, including those with systemic juvenile idiopathic arthritis (SJIA) and adult onset Still’s disease (AOSD).
Sobi senior vice-president, chief medical officer and Research & Development head Milan Zdravkovic said: “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.”
Set to be conducted in 81 subjects across North America, the Phase III trial is designed to compare two subcutaneous doses of anakinra with placebo.
The firm has already initiated patient recruitment last month for the evaluation of Elocta (efmoroctocog alfa) in the ReITIrate trial to treat haemophilia A.
Being conducted in partnership with Bioverativ Therapeutics, the multi-centre, open-label trial will assess the immune tolerance induction (ITI) potential of Elocta in subjects with inhibitors that could not be resolved with other treatments.
Elocta is a recombinant clotting factor therapy engineered using Fc fusion technology to prolong circulation in the body.