New Delhi: A phase 3 trial evaluating ruxolitinib (Jakafi; Incyte) for the treatment of coronavirus disease 2019 (COVID-19)-associated cytokine storm is being initiated in patients 12 years of age and older.
Ruxolitinib is an inhibitor of Janus Associated Kinases (JAKs) JAK1 and JAK2, which mediate the signaling of a number of cytokines and growth factors. Some evidence has suggested that regulating overactive signaling through the JAK-STAT pathway during a cytokine storm could be a potential treatment approach for COVID-19 patients.
The RUXCOVID study will be sponsored by Incyte in the US and Novartis outside of the US and will enroll approximately 400 patients globally. The study will evaluate the safety and efficacy of ruxolitinib vs placebo in patients with COVID-19 associated cytokine storm receiving standard of care therapy.
Patients will be randomized to receive oral ruxolitinib 5mg twice daily or placebo for a total of 14 days; an additional 14 days of study therapy may be administered to those whose symptoms do not improve or worsen after 14 days of treatment. The primary outcome measure of the study is the proportion of patients who die, develop respiratory failure requiring mechanical ventilation, or those who require intensive care unit (ICU) care by day 29.
In addition to the trial, Incyte will be initiating a separate emergency Expanded Access Program that will allow eligible patients with severe COVID-19 associated cytokine storm to receive ruxolitinib while it is being investigated. Information on the Expanded Access Program can be found here.
According to Incyte, there is an ample supply of ruxolitinib in the US to meet the needs of patients receiving the treatment for its approved indications as well as for those participating in clinical trials.
“We thank the FDA for the expedited review of the RUXCOVID study and hope to enroll this important clinical trial as quickly as possible to determine the potential utility of ruxolitinib for treatment of patients with severe COVID-19 associated cytokine storm,” said Steven Stein, MD, Chief Medical Officer, Incyte.