The company is working with the US Food & Drug Administration (FDA) to commence a randomised, double-blind and placebo-controlled phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
The study will assess the safety and efficacy of Actemra/RoActemra plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared against placebo plus standard of care.
Claimed to be the first global study of Actemra/RoActemra in this setting, the trial is expected to begin in early April and aims to recruit up to 330 patients across the globe including the US.
The primary and secondary endpoints comprise of clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
The patients will be followed for 60 days post-randomisation, and an interim analysis will be carried to look for early evidence of efficacy, said Roche.
According to the Swiss healthcare company, the Actemra/RoActemra was included in the seventh updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC).
Actemra/RoActemra is said to be the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations to treat adult patients with moderate-to-severe active rheumatoid arthritis (RA).
Roche chief medical officer and global product development head Dr 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.”
In January this year, Roche announced that its risdiplam has achieved the primary endpoint in the FIREFISH study in infants with type 1 spinal muscular atrophy.