Incyte announced that they are working in partnership with the FDA to initiate a phase III clinical trial to evaluate the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC), compared to SoC therapy alone, in patients with coronavirus disease 2019 (COVID-19) induced cytokine storm.1
The global collaborative study, titled RUXCOVID, will be sponsored by Incyte in the US, and Novartis outside of the US.
Moreover, Incyte is also expecting to initiate a separate open-label emergency Expanded Access Program (EAP) in the US. The protocol will allow patients who are eligible with severe COVID-19 associated cytokine storm to receive ruxolitinib while it is being investigated for this indication.
“Our intent is to build on emerging evidence from independent studies to further establish the role ruxolitinib could play in balancing immune response to the infection and…