Eli Lilly said Monday that the first patient has been enrolled in a phase 3 study testing its Incyte-partnered JAK1/JAK2 inhibitor Olumiant (baricitinib) in hospitalized adults with COVID-19. The trial, which will be conducted in the US, Europe and Latin America, is expected to recruit 400 patients who have at least one elevated marker of inflammation, but do not need invasive mechanical ventilation at study entry.
Participants will be randomly assigned 4 mg of Olumiant daily or placebo, both on top of background therapy, for up to 14 days or until discharge from hospital. The primary endpoint is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by day 28. Secondary outcomes will look at the proportion of patients with clinical improvement at different time points, time to recovery, duration of hospitalisation, number of ventilator-free days and mortality over a 28-day period. Results are expected in the next few months.
Complementing ACTT 2 results
According to Eli Lilly, the trial will complement data from the ACTT 2 study, led by the US National Institute of Allergy and Infectious Diseases, which is testing Olumiant against placebo, in combination with Gilead Sciences’ remdesivir, in hospitalised adults with COVID-19. ACTT 2 is evaluating time to recovery after 29 days in more than 1000 patients as a primary endpoint.
Eli Lilly noted that it is also supporting certain ongoing investigator-initiated trials in Europe and North America for hospitalised patients with COVID-19 infections. “These studies by academic and government institutions will provide information on hundreds of additional patients treated with Olumiant and either placebo or active comparators,” the drugmaker said.
Olumiant is approved in the US and several other countries as a treatment for adults with moderately to severely active rheumatoid arthritis.