ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKE

A RANDOMIZED, DOUBLE BLIND, MULTICENTER, MULTINATIONAL, PLACEBO CONTROLLED, PARALLEL GROUP, SINGLE DOSE, ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKE - ACTISAVE

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002148-56-FR

Enrollment

1000

Registered

2021-05-20

Start date

2021-07-22

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke MedDRA version: 22.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852

Interventions

Product Name: glenzocimab Product Code: ACT017 Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult male or female patients = 18 years (i.e., at least 18 years old at time of randomization). 2. Having given their own written consent or legal representative consent or emergency consent in accordance with local legal requirements. 3. 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 4. Presenting with a pre-IVT NIHSS = 4 5. In whom thrombolysis with tPA is or has been initiated, whether or not patients are additionally eligible to mechanical thrombectomy (MT) 6. 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 7. Women of childbearing potential must have a negative pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78

Exclusion criteria

Exclusion criteria: 1. Coma, or NIHSS >25 2. Patients < 18 years 3. Prior ischemic stroke within the past 3 months 4. mRS pre-stroke known to be = 2 5. Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on Baseline Computed Tomography Angiography (CTA) or Magnetic Resonance Imaging with vascular injection (MRA) 6. 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 9. Known renal insufficiency (Grades 4-5 – severe or terminal) 10. Known allergic reaction to contrast agents 11. Prior cardiopulmonary resuscitation < 10 days 12. Childbirth within < 10 days 13. Epileptic seizure at symptom onset 14. Life expectancy < 3 months 15. Pregnancy or breastfeeding 16. Females of childbearing potential not using effective birth control methods 17. Life expectancy (apart for stroke) greater than 3 months 18. Known current participation in another clinical investigation with experimental drug.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy within the first 4.5 hrs following an acute ischemic stroke of a single IV (bolus + infusion) dose of glenzocimab in addition to the pharmacologic standard of care by tissue plasminogen activator (tPA), with or without the addition of mechanical thrombectomy, with a specific focus on the Day 90 modified Rankin Scale (mRS).;Secondary Objective: Efficacy: • To assess the evolution of the National Institute of Health Stroke Scale (NIHSS) score. Safety: • To assess the number of the following events: o symptomatic and non-symptomatic intracranial hemorrhages, o deaths, o serious adverse events (SAEs), o suspected unexpected serious adverse reactions (SUSARs), o bleeding-related events, o treatment emergent adverse events (TEAEs) Quality of Life: • To evaluate Quality of Life at the end of study follow-up with a recognized QoL scale. Medico-Economics: • To collect care and economic data to support a cost-utility model at the end of Phase III.;Primary end point(s): Primary Efficacy Endpoint: Ordinal modified Ranking Scale assessed at Day 90;Timepoint(s) of evaluation of this end point: Ordinal mRS assessed at Day 90	—

Measure

Time frame

Main Objective: To assess the efficacy within the first 4.5 hrs following an acute ischemic stroke of a single IV (bolus + infusion) dose of glenzocimab in addition to the pharmacologic standard of care by tissue plasminogen activator (tPA), with or without the addition of mechanical thrombectomy, with a specific focus on the Day 90 modified Rankin Scale (mRS).;Secondary Objective: Efficacy: • To assess the evolution of the National Institute of Health Stroke Scale (NIHSS) score. Safety: • To assess the number of the following events: o symptomatic and non-symptomatic intracranial hemorrhages, o deaths, o serious adverse events (SAEs), o suspected unexpected serious adverse reactions (SUSARs), o bleeding-related events, o treatment emergent adverse events (TEAEs) Quality of Life: • To evaluate Quality of Life at the end of study follow-up with a recognized QoL scale. Medico-Economics: • To collect care and economic data to support a cost-utility model at the end of Phase III.;Primary end point(s): Primary Efficacy Endpoint: Ordinal modified Ranking Scale assessed at Day 90;Timepoint(s) of evaluation of this end point: Ordinal mRS assessed at Day 90

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Efficacy Endpoints: • Neurological Status Change as assessed by: o Response defined by a relative decrease (%) in NIHSS value at 24 hrs compared to pre-IVT value higher than 30%. • modified Ranking Scale assessed at Day 90 o Response defined as “0-1 (‘favorable outcome’ i.e., with no symptoms or no significant disability) vs. other categories. o Response defined as “0-2 (functionally independence) vs. other categories. o Utility-weighed mRS assessed at 3 months (the mean utility values (SD) for mRS categories 0 to 6 will be respectively: 0.95 (0.08), 0.93 (0.13), 0.83 (0.21), 0.62 (0.27), 0.42 (0.28), 0.11 (0.28), and 0 (0)). • Neurological Status Change as assessed by: o Response defined by a decrease from pre-IVT value in 24 hrs NIHSS score = 8 points or score = 0) o Response defined by a decrease from pre-IVT value in 24 hrs NIHSS score = 4 points or score = 0) o Worsening defined by an increase from pre-IVT value in 24 hrs NIHSS score = 8 points.) o Worsening defined by an increase from pre-IVT value in 24 hrs NIHSS score = 4 points.) • Quality of Life as assessed at Day 90 by the EuroQol-5 Dimension. A Quality of Life Scale (EQ-5D-5L). SAFETY Secondary Endpoints: Incidence of the following events: • Deaths within the first 24 hrs and over the whole study period until Day 90 (Kaplan-Meier curve) • Symptomatic intracranial hemorrhages, defined by both anatomical imaging (according to Heidelberg's classification) AND an increase in NIHSS score by 4 points or greater, or death that is not explained otherwise (according to ECASS III study definition) • Non-symptomatic hemorrhages, seen on 24-hr plain CT-Scan, not present at baseline assessment, once other diagnoses are excluded • Incidence, nature and severity of Adverse Events, SAEs, bleeding-related events, and Treatment-Emergent Adverse Events (TEAEs) • Change in vital signs at any visit until Day 7 or discharge as compared to Baseline • Change in clinical laboratory assessments	—

Measure

Time frame

Secondary end point(s): Secondary Efficacy Endpoints: • Neurological Status Change as assessed by: o Response defined by a relative decrease (%) in NIHSS value at 24 hrs compared to pre-IVT value higher than 30%. • modified Ranking Scale assessed at Day 90 o Response defined as “0-1 (‘favorable outcome’ i.e., with no symptoms or no significant disability) vs. other categories. o Response defined as “0-2 (functionally independence) vs. other categories. o Utility-weighed mRS assessed at 3 months (the mean utility values (SD) for mRS categories 0 to 6 will be respectively: 0.95 (0.08), 0.93 (0.13), 0.83 (0.21), 0.62 (0.27), 0.42 (0.28), 0.11 (0.28), and 0 (0)). • Neurological Status Change as assessed by: o Response defined by a decrease from pre-IVT value in 24 hrs NIHSS score = 8 points or score = 0) o Response defined by a decrease from pre-IVT value in 24 hrs NIHSS score = 4 points or score = 0) o Worsening defined by an increase from pre-IVT value in 24 hrs NIHSS score = 8 points.) o Worsening defined by an increase from pre-IVT value in 24 hrs NIHSS score = 4 points.) • Quality of Life as assessed at Day 90 by the EuroQol-5 Dimension. A Quality of Life Scale (EQ-5D-5L). SAFETY Secondary Endpoints: Incidence of the following events: • Deaths within the first 24 hrs and over the whole study period until Day 90 (Kaplan-Meier curve) • Symptomatic intracranial hemorrhages, defined by both anatomical imaging (according to Heidelberg's classification) AND an increase in NIHSS score by 4 points or greater, or death that is not explained otherwise (according to ECASS III study definition) • Non-symptomatic hemorrhages, seen on 24-hr plain CT-Scan, not present at baseline assessment, once other diagnoses are excluded • Incidence, nature and severity of Adverse Events, SAEs, bleeding-related events, and Treatment-Emergent Adverse Events (TEAEs) • Change in vital signs at any visit until Day 7 or discharge as compared to Baseline • Change in clinical laboratory assessments

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Countries

Belgium, Czechia, Czech Republic, Denmark, France, Germany, Hungary, Poland, Russian Federation, Slovakia, Spain, United Kingdom, United States

Contacts

Public ContactRegulatory Affairs Manager

ACTICOR BIOTECH

jessica.jami@acticor-biotech.com33665460479

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026