Authors: Sharon Salt, Senior Editor
Biogen (MA, USA) has received the green light from the US FDA to proceed with the Phase IIIB re-dosing study of aducanumab in order to evaluate the drug’s long-term safety and tolerability in individuals with Alzheimer’s disease. The Phase IIIB, open-label, multicenter study is estimated to start on 31 March 2020 and will aim to enroll 2400 participants.
The primary objective of the trial is to evaluate the long-term safety and tolerability of aducanumab in previously treated participants or treatment-naïve participants. Each trial participant will receive an intravenous infusion of 10 mg/kg aducanumab every 4 weeks for a total duration of 100 weeks.