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Clinical Trial Summary

A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study (respectively Part 1 and 2). The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care.


Clinical Trial Description

A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study (respectively Part 1 and 2). The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care. In all patients, thrombolysis (IVT with tPA: alteplase) should have been initiated prior to randomization, within 4.5 hrs post onset of acute ischemic stroke symptoms. Eligible patients will be randomized and the infusion of glenzocimab or of its matching placebo should be administered (infusion initiation) ideally during the tPA infusion but no later than one hour following the end of tPA administration. Patients will be randomized 1:1 between groups (glenzocimab or placebo). A minimization program will account for the following factors: type of SOC, (IVT alone vs. IVT + MT), Baseline Severity (NIHSS <10 vs. ≥ 10), age group (<65, 65-79, ≥80 years) in order to balance each group composition. The allocation of each patient in any given center to an active treatment or placebo will strictly follow a central randomization scheme. Clinical supplies allocation to centers should provide the necessary material so that any eligible patient can receive the assigned treatment. An IRT will be used to manage randomization and drug shipment. The whole process will be handled in a manner that it is blinded for the treatment received to all involved study personnel. An Independent Data Monitoring Committee (IDMC) will be composed of at least two clinicians with expertise in the relevant clinical field (a neurologist and a neuroradiologists), and a clinical pharmacologist. They will be supported by a dedicated independent statistician. The statistician will be available to analyze the data for the IDMC (either blinded or unblinded). All cases of intracranial hemorrhage (symptomatic or not) will be thoroughly reviewed, including the radiological images and the pharmacovigilance data. IDMC members will process the information and will issue their recommendations as per the IDMC Charter. Specific Statistical Analysis Plan (SAP) per each analysis (2 interim and one final) will be made available to the IDMC for each of the 2 interim and final analyses. Five IDMC meetings are pre-scheduled: 3 of them for a safety evaluation exclusively (after 100, 600 and 800 patients recruited) and 2 of them for efficacy and safety evaluation (after 200 and 400 patients recruited). In case of an urgent safety concern, ad-hoc meetings will be triggered. Bleeding events are an integral part of these analyses, and a focus on symptomatic/non-symptomatic intra-cranial bleeds is repeatedly considered. Competent Authorities / Agencies should be notified at the end of the Part 1 and regulatory meetings, such as End-of-Phase II meetings should take place thereafter. Advice from these agencies may be likely to alter Part 2 plans as presented here. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05070260
Study type Interventional
Source Acticor Biotech
Contact Andrea Comenducci, MD
Phone +33631003997
Email [email protected]
Status Recruiting
Phase Phase 2/Phase 3
Start date September 23, 2021
Completion date December 30, 2025

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