Incyte announces initiation of phase III RUXCOVID study for Jakafi as a treatment for patients with COVID-19 associated cytokine storm.

Incyte announced the initiation of RUXCOVID, a global, randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients aged greater than 12 years with COVID-19 associated cytokine storm . The collaborative study is sponsored by Incyte in the United States and Novartis outside of the United States.

The composite primary endpoint is the proportion of patients who die, develop respiratory failure (require mechanical ventilation) or require intensive care unit (ICU) care by Day 29. Secondary endpoints comprise various efficacy assessments including evaluation of clinical status using a 9-point ordinal scale; in-hospital outcomes (mortality rate; proportion of patients requiring mechanical ventilation; duration of hospitalization, ICU stay, supplemental oxygen, invasive mechanical ventilation); change in the National Early Warning Score (NEWS2); change in SpO2/FiO2 ratio; proportion of patients with no oxygen therapy (oxygen saturation of greater than 94% on room air); and safety. RUXCOVID will enroll approximately 400 patients globally.

Additionally, given the urgent nature of the COVID-19 pandemic, Incyte is also initiating a separate emergency Expanded Access Program (EAP) in the United States. The protocol will allow eligible patients with severe COVID-19 associated cytokine storm to receive ruxolitinib while it is being investigated for this indication.