Acute Ischemic Stroke Interventional Study

Summary

To assess safety of single IV (bolus + infusion) doses of ACT017 in patients with an acute ischemic stroke in addition to best emergency standard of care (including fibrinolysis by rtPA with or without added thrombectomy), with a specific focus on hemorrhage, whether clinically symptomatic (NIHSS score + 4 points or death, without other explanation), or seen (excluding other diagnoses) on 24-hour (hr) CT scan, serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and medically important events and other safety items including biological and immunological tolerability.

Timeline

Start

2019-03-06

Primary completion

2021-09-27

Completion

2021-09-27

Outcome

Met primary endpoint

release “Achievement of the study ’s primary endpoint, confirming glenzocimab ’s very favorable safety profile” acticor-biotech.com ↗

Publications

• Background Voors-Pette C, Lebozec K, Dogterom P, Jullien L, Billiald P, Ferlan P, Renaud L, Favre-Bulle O, Avenard G, Machacek M, Pletan Y, Jandrot-Perrus M. Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT017, an Antiplatelet GPVI (Glycoprotein VI) Fab. Arterioscler Thromb Vasc Biol. 2019 May;39(5):956-964. doi: 10.1161/ATVBAHA.118.312314.
• Background Renaud L, Lebozec K, Voors-Pette C, Dogterom P, Billiald P, Jandrot Perrus M, Pletan Y, Machacek M. Population Pharmacokinetic/Pharmacodynamic Modeling of Glenzocimab (ACT017) a Glycoprotein VI Inhibitor of Collagen-Induced Platelet Aggregation. J Clin Pharmacol. 2020 Sep;60(9):1198-1208. doi: 10.1002/jcph.1616. Epub 2020 Jun 4.
• Kohrmann M, Berrouschot J, Serena J, Bornstein NM, Iversen HK, Kalladka D, Krastev G, Molina CA, Peeters A, Sanak D, Sibon IP, Della Schiava L, Tembl JI, Masjuan J, Soda H, Richard S, Eichlova Z, Czap AL, Avenard G, Binay S, Bougamra S, Comenducci A, Drumez E, Meilhoc A, Pletan Y, Sari A, Toledano E, Grouin JM, Grotta JC; ACTISAVE Study Group. Glenzocimab Efficacy and Safety Added to Intravenous Thrombolysis With or Without Mechanical Thrombectomy in Patients With Acute Ischemic Stroke-ACTISAVE: A Prospective, Randomized, Double-Blind Study. Stroke. 2026 May;57(5):1116-1125. doi: 10.1161/STROKEAHA.125.052935. Epub 2026 Mar 16.
• Mazighi M, Kohrmann M, Lemmens R, Lyrer PA, Molina CA, Richard S, Toni D, Pletan Y, Sari A, Meilhoc A, Jandrot-Perrus M, Binay S, Avenard G, Comenducci A, Grouin JM, Grotta JC; ACTIMIS Study Group. Safety and efficacy of platelet glycoprotein VI inhibition in acute ischaemic stroke (ACTIMIS): a randomised, double-blind, placebo-controlled, phase 1b/2a trial. Lancet Neurol. 2024 Feb;23(2):157-167. doi: 10.1016/S1474-4422(23)00427-1.

Drugs

Indications