The Phase III DEVENT study evaluated the efficacy and safety of ruxolitinib plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated ARDS. Credit: Arek Socha from Pixabay.

Incyte has announced that its Phase III DEVENT study of ruxolitinib for treating patients on mechanical ventilation with Covid-19 associated Acute Respiratory Distress Syndrome (ARDS) failed to meet its primary endpoint.

ARDS is a condition where fluid builds up in the air sacs of the lungs, resulting in inflammation.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The randomised, double-blind, placebo-controlled, multicentre clinical trial was designed to assess the safety and efficacy of ruxolitinib (5mg and 15mg) plus standard of care (SoC) compared to SoC plus placebo in patients with Covid-19 associated ARDS on mechanical ventilation.

The primary endpoint was determining the mortality rate at day 29 among patients administered with ruxolitinib 5mg twice daily plus SoC therapy, ruxolitinib 15mg, plus SoC compared with placebo plus SoC.

The results indicated an improvement in mortality rate compared to placebo, however, the data was not statistically significant.

Furthermore, the analysis of the study identified clinically and statistically significant improvement in mortality in 5mg and 15mg treatment arms among US study population.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Participants from the US accounted nearly 91% of the total study population.

A post-hoc analysis also found statistically significant improvement in mortality in both the study arms.

Incyte chief medical officer Steven Stein said: “There remains a significant unmet medical need for treatments that may potentially improve survival outcomes for patients suffering from severe Covid-19 related complications, specifically those requiring mechanical ventilation.

“We hope the results of this study, and the potential utility of ruxolitinib for treatment of patients with severe Covid-19 associated ARDS, will contribute to the advances being made across the scientific community to alleviate the burden this pandemic has placed on patients, as well as the healthcare system.

“We look forward to discussing the results of the DEVENT study with regulatory authorities in the US.”