- Phase III study did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care)1
- Detailed results will be submitted for publication to support scientific understanding of JAK inhibition in COVID-19 and inform ongoing research
- Novartis commitment to address COVID-19 pandemic remains strong with multiple research collaboration initiatives ongoing
Basel, December 14, 2020 - Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint1. Initial data show there was no statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by Day 29, compared to SoC alone1. The trial also did not show clinically relevant benefit among secondary and exploratory endpoints including mortality rate by Day 29, and time to recovery (no longer infected, or ambulatory with no or minimal limitations)1.
"While the RUXCOVID trial did not give us the results we hoped for, we will continue working with the medical community to analyze its findings to better understand COVID-19 and the role of JAK inhibition," said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. "We would like to thank the front-line clinical teams and staff at each of the trial sites and the hundreds of patients who volunteered to participate and their loved ones. We are deeply grateful to them and will continue our dedicated scientific research into the ongoing global pandemic."
In the trial, the proportion of patients who died, or required mechanical ventilation due to respiratory failure or ICU care by Day 29, the primary endpoint, was 12.0% for ruxolitinib plus SoC vs. 11.8% for placebo plus SoC (OR: 0.91 [95% CI: 0.48-1.73]; p=0.769)1. Ruxolitinib was generally well-tolerated, and a comprehensive analysis including safety data is ongoing1. The results of RUXCOVID do not affect any ongoing trials for ruxolitinib in non-COVID-19 diseases.
RUXCOVID (NCT04362137) is a Phase III multicenter, randomized, double-blind, placebo-controlled, 29-day study to evaluate the efficacy and safety of ruxolitinib plus standard of care (SoC) therapy compared to placebo plus SoC therapy in patients aged