Roche has collaborated with the US Food and Drug Administration (FDA) to conduct a Phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised adults with severe Covid-19 pneumonia.
Actemra/RoActemra is an anti-IL-6 receptor biologic approved to treat moderate-to-severe active rheumatoid arthritis (RA) in adults.
Earlier this month, Roche received Chinese approval for the use of the drug to treat patients developing severe complications from Covid-19.
The new randomised, double-blind, placebo-controlled Phase III trial will be conducted in alliance with the US Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).
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It will assess the safety and efficacy of Actemra in combination with standard of care compared to placebo.
The Phase III study is reported to be the first global trial in this setting and will enrol nearly 330 patients globally, including in the US. Enrolment is set to start early next month.
The primary and secondary endpoints of the trial include clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.
Roche chief medical officer and Global Product Development head Levi Garraway said: “We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalised with Covid-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease.
“In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the Covid-19 pandemic, and we will share the results as soon as possible.”
The company noted that multiple independent studies are being conducted to assess the drug in patients with Covid-19 pneumonia.
This Phase III trial is considered important due to lack of well-controlled studies and availability of limited published evidence regarding the drug’s safety and efficacy in Covid-19 patients.