Incyte Initiates P-III RUXCOVID Study Evaluating Jakafi (ruxolitinib) to Treat Patients with COVID-19 Associated Cytokine Storm
Shots:
- The P-III RUXCOVID study involves assessing of ruxolitinib (5mg- bid) + SoC vs PBO + SoC in 400 patients in a ratio (2:1) aged ≥12 yrs. with COVID-19 associated cytokine storm. The study is sponsored by the Incyte in the US and Novartis outside the US
- The composite 1EP is the proportion of patients who die- develop respiratory failure (require mechanical ventilation) or require ICU care by day 29. The 2EPs includes evaluation of clinical status using a 9-point ordinal scale- in-hospital outcomes- change in the NEWS2- change in SpO2/FiO2 ratio- proportion of patients with no oxygen therapy and safety
- Additionally- Incyte is initiating an emergency EAP in the US- allowing patients to receive ruxolitinib while it is being investigated. Jakafi is a first-in-class JAK1/JAK2 inhibitor- approved by the US FDA for PV in adults who have had an inadequate response to hydroxyurea- in adults with intermediate/high-risk MF- including primary MF- post-polycythemia vera MF- post-essential thrombocythemia MF and for steroid-refractory acute GVHD in adult and pediatric patients aged ≥12 yrs.
Click here to read full press release/ article | Ref: Incyte | Image: Technical.ly
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