The RAISE trial is an ongoing Phase 2 study evaluating the RNA aptamer BB-031 (0.5-6 mg/kg) versus placebo in patients with acute ischemic stroke, with primary endpoint results pending.
RCT (n=48)
Double-blind
3:1
Yes
Does BB-031 improve safety and clinical outcomes in acute ischemic stroke patients?
The RAISE trial is an ongoing Phase 2 study evaluating the safety and efficacy of the novel vWF inhibitor BB-031 in patients with acute ischemic stroke.
Abstract Background and aims BB-031, an RNA aptamer, potently and rapidly inhibits von Willebrand Factor (vWF) binding to its platelet receptor, is developed to impede and resolve thrombus formation and embolization. A Phase1 study in healthy volunteers demonstrated its safety and dose-dependent inhibition of vWF-binding and thrombosis. Methods The Recanalization in Acute Ischemic StrokE (RAISE) trial is an ongoing Phase 2, international, randomized, placebo-controlled, double-blind study evaluating BB-031’s safety, tolerability, pharmacokinetics, and pharmacodynamics in acute ischemic stroke (AIS) patients (NCT06226805). Results Part A assessed single ascending doses (0.5–4 mg/kg) in 48 patients (3:1 randomization BB-031:placebo). Following unblinded DSMC review, Part B will enroll ~180 patients, starting with 2 mg/kg and escalating to 6 mg/kg after DSMC approval. Eligible patients must be enrolled within 24 hours of symptom onset, with confirmed anterior circulation occlusion and no prior/planned thrombolysis. Conclusions The primary endpoint is incidence of symptomatic intracranial hemorrhage (ICH) at 24 hours. Secondary endpoints include any ICH, pharmacokinetic parameters, and vWF activity modulation. Exploratory clinical outcomes are recanalization rates at 24-hours, NIHSS, and mRS at 90 days. Conflict of interest
Nimjee et al. (Fri,) conducted a rct in Acute ischemic stroke (n=48). BB-031 vs. Placebo was evaluated on Incidence of symptomatic intracranial hemorrhage (ICH) at 24 hours. The RAISE trial is an ongoing Phase 2 study evaluating the RNA aptamer BB-031 (0.5-6 mg/kg) versus placebo in patients with acute ischemic stroke, with primary endpoint results pending.