On Apr. 17, 2020, Incyte announced the initiation of RUXCOVID, a global, randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients aged =12 years with COVID-19 associated cytokine storm. The collaborative study was sponsored by Incyte in the United States and Novartis outside of the U.S.

The composite primary endpoint was 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 ≥94% on room air); and safety. RUXCOVID will enroll approximately 400 patients globally.

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

RUXCOVID was the first Phase 3, randomized, placebo-controlled study designed to evaluate the efficacy and safety of ruxolitinib in patients with COVID-19 associated cytokine storm. At present, there is ample commercial and clinical supply of ruxolitinib in the United States to meet the needs of U.S. patients receiving ruxolitinib in its approved indications and those participating in clinical trials. Incyte was increasing manufacturing efforts to respond to anticipated supply needs related to COVID-19 studies and working closely with distribution partners to monitor the supply of ruxolitinib.

Cytokine storm is a severe immune overreaction that can be triggered by a viral infection and can lead to serious complications, including pneumonia and acute respiratory distress syndrome (ARDS). Patients with COVID-19 associated cytokine storm who experience these complications often require intensive care, including intubation and the use of mechanical ventilation, and are at an increased risk of mortality.

Emerging evidence suggests that regulating overactive signaling through the JAK-STAT pathway during a cytokine storm associated with COVID-19 could be a potential treatment approach, and it is hypothesized that ruxolitinib, a JAK1/JAK2 inhibitor, may be able to play a role in treating these patients. Currently, there is limited clinical evidence on the safety and efficacy of ruxolitinib for the treatment of COVID-19 associated cytokine storm, and ruxolitinib is not FDA-approved for this use.

RUXCOVID is a global, randomized, double-blind, placebo-controlled, 29-day, multi-center Phase 3 study evaluating the efficacy and safety of ruxolitinib plus standard of care (SoC) therapy in patients aged ≥12 years with COVID-19 associated cytokine storm compared to placebo plus SoC therapy.