A Phase 2/3 interventional study of Glenzocimab and Placebo in Stroke, Acute and Stroke, Ischemic, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2/3, Interventional, and Treatment
Emergent reperfusion is the main goal for acute ischemic stroke therapy (AIS). Endovascular therapy (EVT) is recommended within 6 hrs of stroke onset, and up to 24 hrs following perfusion imaging criteria.
Despite the major benefit associated with MT, more than 50% of the patients remain disabled at 3 months. Reperfusion rates after MT are critical to determine functional outcome. However, complete reperfusion is obtained in only 50 % of the patients, due to, at least in part, erratic emboli and/or no-reflow processes. The aim of this study is to evaluate the efficacy of glenzocimab in addition to EVT and compared to EVT plus placebo, whether or not associated with ntravenous thrombolysis (IVT), on functional outcome at day 90.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 108 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Informed consent signed:
Post-menopausal women defined as not having menses for 12 months without an alternative medical cause. For WOCBP, a highly effective birth control method should be in place that can achieve a failure rate of less than 1% per year that should last for at least 2 months after IMP administration.
Birth control methods which may be considered as highly effective in WOCBP include:
Birth control methods which may be considered as highly effective for men and that should last for 4 months after IMP administration include:
Please note that hormonal contraception is a risk factor for thromboembolic events and attention should be called to reconsider it passed the acute stroke phase.
Exclusion Criteria:
Drug: Placebo
Drug: Glenzocimab
Glenzocimab (ACT-017, Acticor Biotech) is formulated for IV administration as a sterile product with 20 mM sodium citrate and 130 mM sodium chloride buffer at pH of 5.0. It is supplied for clinical trial use in vials containing 50 mL of the drug product at a concentration of 10 mg/mL. Each vial contains 500 mg of glenzocimab. Two vials (2x500 mg) of glenzocimab should be administered concomitantly for eligible patients for a total daily dose of 1g. Glenzocimab is intended to be administered as an IV infusion over 6 hrs, with 1/4 of the dose administered by a 15-minute bolus and 3/4 of the dose administered by 5h45min-slow infusion.
Placebo of glenzocimab is 0.9%NaCl (Acticor Biotech) for IV administration. It is supplied for clinical trial use in vials of 50 mL. Two vials of placebo of glenzocimab should be administered concomitantly for eligible patients.
Efficacy mRS 90
The primary efficacy endpoint is the functional outcome assessed by the modified Rankin Scale (mRS) at day 90 +/- 15 days. The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: 90 days
Favorable functional outcome
Favorable functional outcome defined by a mRS ≤ 2 at day 90 +/- 15 days
Time frame: 90 days
Severe handicap
Proportion of patients with a severe handicap: mRS equal to 4, 5 or 6 at day 90 +/- 15 days
Time frame: 90 days
Survival
Overall survival at 90 days and 1 year
Time frame: 90 days and 1 year
Early reperfusion outcomes : volume
Stroke volume by MRI at 24 hrs
Time frame: 24 hours
Early reperfusion outcomes : eTICI
Reperfusion at the end of procedure assessed by the expanded treatment in cerebral infarction (eTICI) score.The eTICI is defined as follows : grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2a: reperfusion of 1-49% of the territory grade 2b50: reperfusion of 50-66% of the territory grade 2b67: reperfusion of 67-89% of the territory grade 2c: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion)
Time frame: 24 hours
Early reperfusion outcomes NIHSS
Early neurological improvement by National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) at 24 hrs. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time frame: 24 hours
Quality of life
EQ5D-5L at day 90 and at 1 year. EQ-5D is a standardised measure of health-related quality of life. The EQ-5D-5L descriptive system uses five dimensions. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). EQ-5D-5L is the sum of the five dimensions.
Time frame: 90 days and 1 year
IntraCranial Hemorrhages
Incidence of symptomatic or non-symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs
Time frame: 24 hours
Symptomatic IntraCranial Hemorrhages
Incidence of symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs
Time frame: 24 hours
Non-Symptomatic IntraCranial Hemorrhages
Incidence of non-symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs
Time frame: 24 hours
Adverse event
Incidence, nature and severity of Adverse Events, SAEs, SUSARs, Bleeding-Related Events (BREs) and/or Treatment-Emergent Adverse Events (TEAEs), at 24 hrs, at D7/discharge, 30 days and 90 days
Time frame: 24 hours, 7 days, 30 days, 90 days
Bleeding relating events
Incidence of bleeding-related events at 90 days
Time frame: 90 days
Anti-glenzocimab antibodies
Anti-glenzocimab antibodies (ADA) blood concentration at 3 months for 50 patients.
Time frame: 3 months
Plan to share: Undecided
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Assistance Publique - Hôpitaux de Paris