NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19
ACTIV-5/BET-B trial amended in the context of Humanigen’s positive Phase 3 lenzilumab LIVE-AIR study
Primary endpoint focuses on survival without ventilation by day 28 in patients with baseline C-reactive protein (CRP) levels less than 150 mg/L
Study modification may enable Humanigen to use ACTIV-5/BET-B as a confirmatory study to support a future Biologics License Application (BLA)
Approximately half of the 400 patients are already enrolled in ACTIV-5/BET-B
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