Adaptive Efficacy and Safety Study of Glenzocimab Used as an add-on Therapy on Top of Standard of Care un the 4.5 Hours Following an Acute Ischemic Stroke

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    1000
  • sponsor
    Acticor Biotech
Updated on 13 October 2021

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.

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.

Details
Condition Acute Ischemic Stroke
Treatment intravenous placebo, Intravenous glenzocimab (ACT017) 1000 mg
Clinical Study IdentifierNCT05070260
SponsorActicor Biotech
Last Modified on13 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult male or female patients 18 years (i.e., at least 18 years old at time of randomization)
Having given their own written consent or legal representative consent or emergency consent in accordance with local legal requirements
Presenting with an acute disabling ischemic stroke either in the anterior or in posterior circulation, with or without visible occlusion, with a known time of onset, that is 4.5 hrs
Presenting with a pre-IVT NIHSS 4
In whom thrombolysis with tPA is or has been initiated, whether or not patients are additionally eligible to mechanical thrombectomy (MT)
With an effective birth control method (if relevant) that should last for at least 2 months for non-menopausal women, and 4 months for men after IMP administration if applicable according to local regulatory requirement; birth control methods which may be considered as highly effective include
intrauterine device
intrauterine hormone-releasing system
bilateral tubal occlusion
vasectomized partner
sexual abstinence
Women of childbearing potential must have a negative pregnancy test
Patients affiliated to social security insurance (if applicable, in accordance to local regulations)

Exclusion Criteria

Coma, or NIHSS >25\
Patients < 18 years
Prior ischemic stroke within the past 3 months. 4. mRS pre-stroke known to be 2
Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on Baseline Computed Tomography or Computed Tomography Angiography (CT/CTA) or Magnetic Resonance Imaging with/without vascular injection (MRA/MRI)
Significant mass effect with midline shift. 7. Stroke of hemorrhagic origin. 8. Patients likely to require dual antiplatelet therapy within the 12 hrs after cessation of glenzocimab or placebo infusion for e.g., carotid stenting
Known renal insufficiency (Grades 4-5 - severe or terminal). 10. Known allergic reaction to contrast agents
Known ongoing anti-coagulant therapy. 12. Known ongoing treatment with a mAb. 13. Prior cardiopulmonary resuscitation < 10 days. 14. Childbirth within < 10 days
Epileptic seizure at symptom onset. 16. Life expectancy (except for stroke) < 3 months
Pregnancy or breastfeeding
Females of childbearing potential not using effective birth control methods
Known current participation in another clinical investigation with experimental drug
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