Acute Ischemic StrokePhase 1/2ACTIMISNCT03803007
Acute Ischemic Stroke Interventional Study
A Phase 1/2 study testing Intravenous ACT017 1000 mg in people with Acute Ischemic Stroke, run by Acticor Biotech at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intravenous ACT017 1000 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2019to 27 Sep 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients ≥ 18 years (i.e., at least 18 years old at time of randomization). Extreme caution should be exercised in patients over 80 years of age with regards their general health, neurological status and any concomitant diseases and treatments that are likely to be more common;
- Patients who have given written consent, legal representative consent or emergency consent (including e-consent) in accordance with local legal and IECs/IRBs requirements;
- Patients presenting with an acute disabling ischemic stroke in either the anterior or posterior circulation.The time of onset is known or if unknown, the last time the patient was seen well, was at most 4.5 hrs before confirmation of the diagnosis enabling the initiation of alteplase administration within this time-frame;
- Patients presenting at least a NIHSS ≥ 6 prior to thrombolysis with tPA;
- Patients eligible for, or administered thrombolysis treatment with tPA;
- Patients who can undergo mechanical thrombectomy if eligible;
Show all 14Show fewer
- Patients affiliated to social security insurance (if applicable, in accordance to local regulations);
- Effective birth control method should be used for at least the next 2 months by women, and 4 months by men after IMP administration; birth control methods considered to be highly effective include:
- intrauterine device
- intrauterine hormone-releasing system
- bilateral tubal occlusion
- vasectomized partner
- sexual abstinence (if applicable in accordance to local regulations)
- Women of child-bearing potential must undergo a urinary or plasma pregnancy test with negative results;
Who cannot join
- Coma, and/or NIHSS >25;
- Patients < 18 years of age;
- Prior ischemic stroke within the past 3 months with pre-stroke mRS known to be > 2;
- Baseline CT-scan evaluation: more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline imaging;
- Significant mass effect with midline shift;
- Stroke of hemorrhagic origin;
Show all 42Show fewer
- Contra-indications to thrombolysis with tPA:
- Patients with known hypersensitivity to the active substance alteplase or to any of its excipients;
- Patients with a high risk of hemorrhages:
- significant bleeding disorder at present or within the past 6 months;
- known haemorrhagic diathesis (episodes within past 6 months);
- patients receiving effective oral anticoagulant treatment, e.g. warfarin sodium;
- manifest or recent severe or dangerous bleeding;
- known history of or suspected intra-cranial haemorrhage;
- any history of central nervous system lesion (i.e. trauma, intra-parenchymal neoplasm, unsecured aneurysm, intracranial or spinal surgery, vascular malformation etc..);
- recent (< 10 days) traumatic external heart massage, obstetrical delivery, or puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture);
- bacterial endocarditis, pericarditis;
- acute pancreatitis;
- documented ulcerative gastrointestinal disease during the past 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformations;
- neoplasm involving an increased risk of bleeding;
- severe liver disease, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis;
- major surgery or significant trauma during the past 3 months;
- patients receiving anti-coagulants prior to study: the inclusion may however be considered when the dose or time since the last intake of anticoagulant treatment makes residual efficacy unlikely. This should be confirmed by the appropriate tests of anticoagulant activity for the product(s) concerned to show no clinically relevant activity on the coagulation system defined as follows :
- INR ≤ 1.5 for vitamin K antagonists; .
- Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH): aPPT/ACT/KCT ≤ 39 sec or their patient/witness ratio ≤ 1.2 and/or PT ≤ 16 sec (heparin at sub-therapeutic doses (≤ 50 IU/kg) during the mechanical thrombectomy procedure is authorized);
- Non-Vitamin-K or Direct Oral Anti-Coagulants (NOACs- DOACs) ≤ 50 ng/mL in patients with normal renal function;
- need for carotid stenting together with a dual anti-platelet treatment (on top of glenzocimab); this can be carried out 24 hrs after the initiation of treatment with glenzocimab;
- platelets count <100 × 103/μL (<100 000/ mm3)
- prior hemorrhagic stroke.
- Systolic blood pressure ≥ 185 mm Hg despite appropriate acute therapy to lower blood pressure therapy;
- Diastolic blood pressure ≥ 110 mm Hg; despite appropriate acute therapy to lower blood pressure therapy;
- Glucose >400 mg/dL (>4 g/L) despite treatment;
- Glycemia <50 mg/dL (<0,5 g/L);
- Patients receiving a dual antiplatelet treatment;
- Cardiopulmonary resuscitation within the past 10 days;
- Childbirth within the past 10 days,
- Epileptic seizure at the onset of symptoms;
- Life expectancy < 3 months
- Pregnant or breastfeeding;
- Females of childbearing potential not using effective birth control methods;
- Known severe (grade 3 and above) renal impairment or Glomerular Filtration Rate < 30 ml/min/1.73 m2 or Serum Creatinine > 2X ULN (1.2 mg/dL for men and 1.0 mg/dL for women) at screening;
- Known current participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Multi Center, Multinational, Placebo Controlled, Single Parallel Escalating Dose Safety and Efficacy Study of ACT017 Used as an Add on Therapy on Top of Standard of Care of Acute Ischemic Stroke
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.
Read the detailed description
This first in-patient randomized, double blind, multicenter, multinational, placebo-controlled, parallel-dose 2-phase study combines a dose-escalation phase (1b) and a consolidation phase (2a).
Dose Escalation (Phase 1b):
Phase 1b was designed to (I) assess the dose- related safety and potential efficacy of glenzocimab administered as soon as possible and no later than 3 hours after the start of thrombolysis with tPA (itself administered within 4.5 hrs of the onset of acute ischemic stroke symptoms), and (II) identify the recommended phase 2 dose (RP2D).
During this phase, patients were unevenly randomized between groups, to obtain a total of 60 patients, 12 at each dose level. At the starting level, 8 patients received either glenzocimab at the lowest pharmacologically active dose of 125 mg (n=4) or the matching placebo(n=4). After real-time review by the DSMB of clinical safety and a CT scan (and where available MRI) and giving a favorable opinion, the next patients were randomized in the second cohort (n=8) with 4 patients under a higher dose of 250 mg, 2 patients remaining at the initial starting dose (125 mg), and 2 patients under placebo. Following the same process, and after favorable opinion from the DSMB, patients were randomized in the third cohort (n=10) and received glenzocimab 500 mg (n=4), randomized versus 250 mg (n=2), 125 mg (n=2) or placebo (n=2). Similarly, the fourth cohort (n=12) randomized patients between ahigher dose of 1000 mg (n=4), versus 500 mg (n=2), 250 mg (n=2), 125 mg (n=2), or placebo (n=2). Once this fourth cohort completed, the DSMB issued a further positive opinion and the fifth cohort (n=22) randomized patients to 1000 mg (n=8), versus 500 mg (n=6), 250 mg (n=4), 125 mg (n=2), or placebo (n=2).
Consolidation Phase with Final Dose (Phase 2a):
After having reviewed patient's safety data included in the first part of the study, the DSMB confirmed that the study can continue with the glenzocimab recommended dose of 1000 mg. During this phase, a group of 100 patients will be treated, 50 with glenzocimab and 50 with matching placebo to complete the group of 160 patients planned to participate in this study.
In addition, patients in each treatment arm will be stratified by type of Standard of Care (SOC) administered:
- Thrombolysis with tPA only;
- Thrombolysis with tPA AND mechanical thrombectomy Each treatment arm will contain 25 patients with one SOC, and 25 with the other SOC. The active glenzocimab dose will be that recommended after the last safety analysis has been performed.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intravenous ACT017 1000 mg, Intravenous Placebo
- Keywords
- Haemorrhages, Thrombolysis, Thrombectomy, Anti-platelet, glenzocimab, ACT017, stroke, GPVI
- Medical subject headings
- Ischemic Stroke, Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ACT017 1000 mgDrug
Also called Thrombolysis by rtPA +/- thrombectomy
Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms
Intravenous PlaceboOther
Also called Thrombolysis by rtPA +/- thrombectomy
Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms
| Study group | Role | What they receive |
|---|---|---|
| Intravenous glenzocimab (ACT017) 1000 mg | Experimental | Intravenous glenzocimab (ACT017) 1000 mg to be added to a tissue plasminogen activator +/- mechanical thrombectomy Receives: Drug: Intravenous ACT017 1000 mg |
| Intravenous Placebo | Placebo comparator | Intravenous Placebo to be added to a tissue plasminogen activator +/- mechanical thrombectomy Receives: Other: Intravenous Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic intracranial haemorrhages
Number of participants experiencing a symptomatic haemorrhage defined by a secondary increase in National Institute Health Stroke Scale score by 4 points or greater, or death
Measured: 24 hours
Incidence of non-symptomatic intracranial haemorrhages
Non-symptomatic haemorrhages are those detected by Computerized Tomography scan
Measured: 24 hours
Secondary outcomes (14)
Change from baseline of National Institute Health Stroke Scale score (7 minimum, 42 maximum), brain lesions and vessel recanalization
Absolute change from baseline of National Institute Health Stroke Scale score, change from baseline on brain lesions as assessed by Computerized Tomography scan or Magnetic Resonance Imaging or Magnetic Resonance Angiography, change from baseline on Recanalization as measured by the modified Thrombolysis In Cerebral Infarction score (0 minimum, 3 maximum) on Magnetic Resonance Angiography
Measured: 24 hours
Change from baseline of National Institute Health Stroke Scale score (7 minimum, 42 maximum), brain lesions and vessel recanalization
Relative (%) change from baseline of National Institute Health Stroke Scale score, change from baseline on brain lesions as assessed by Computerized Tomography scan or Magnetic Resonance Imaging or Magnetic Resonance Angiography, change from baseline on Recanalization as measured by the modified Thrombolysis In Cerebral Infarction score (0 minimum, 3 maximum) on Magnetic Resonance Angiography
Measured: 24 hours
Change from baseline of modified Ranking Scale score assessment
modified Ranking Scale score (0 minimum and 6 maximum): number of patients with favorable outcome (score 0-2)
Measured: Day 90
Change from baseline of modified Ranking Scale score assessment
modified Ranking Scale score (0 minimum and 6 maximum): percentage of patients with favorable outcome (score 0-2)
Measured: Day 90
Change from baseline on size of infarct zone
Change from baseline on size of infarct zone assessed by a central Magnetic Resonance Imaging review
Measured: Day 7
Change from baseline on vital signs
Change from baseline on systolic and diastolic blood pressure
Measured: 6 hours, 24 hours, Day 7, Day 30 and Day 90
Change from baseline on vital signs
Change from baseline on heart rate
Measured: 6 hours, 24 hours, Day 7, Day 30 and Day 90
Change from baseline on clinical laboratory assessments
Change from baseline on plasma haemoglobin level
Measured: Day 90
Change from baseline on clinical laboratory assessments
Change from baseline on platelet count
Measured: Day 90
Change from baseline on clinical laboratory assessments
Change from baseline on serum glucose concentration
Measured: Day 90
Change from baseline on clinical laboratory assessments
Change from baseline on serum creatinine concentration
Measured: Day 90
Change from baseline on ElectroCardioGram (ECG)
Change from baseline on 12-lead ElectroCardioGram (ECG)
Measured: 24 hours and Day 90
Evidence of anti-ACT017 antibodies (ADA)
To assess evidence of anti-ACT017 antibodies (ADA) as a possible to ACT017 administration
Measured: Day 30 and Day 90
Pharmacokinetics on ACT017 plasma concentration
Change from baseline on ACT017 plasma concentration
Measured: 30 minutes, 9 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start6 Mar 2019
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The phase Ib of the study with a sequential design has been achieved (5 arms). The second phase IIa is ongoing. The selected dose (1000mg) for this second part will be compared to placebo (2 arms) with a parallel design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acticor Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Comenducci, MD, Study director, Acticor Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803007
- Sponsor's protocol ID
- ACT-CS-002
- Other IDs
- 2018-002855-13, 2018
- Acronym
- ACTIMIS
- Status last verified
- Oct 2021
- First submitted
- 12 Dec 2018
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31017822Renaud 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.
PubMed 32500636Kohrmann 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.
PubMed 42044230Mazighi 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.
PubMed 38267188
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Multi Center, Multinational, Placebo Controlled, Single Parallel Escalating Dose Safety and Efficacy Study of ACT017 Used as an Add on Therapy on Top of Standard of Care of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03803007
- Acronym / sponsor ID
- ACTIMIS / ACT-CS-002
- Conditions
- Acute Ischemic Stroke
- Keywords
- Haemorrhages, Thrombolysis, Thrombectomy, Anti-platelet, glenzocimab, ACT017, stroke, GPVI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Acticor BiotechIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This first in-patient randomized, double blind, multicenter, multinational, placebo-controlled, parallel-dose 2-phase study combines a dose-escalation phase (1b) and a consolidation phase (2a).
Dose Escalation (Phase 1b):
Phase 1b was designed to (I) assess the dose- related safety and potential efficacy of glenzocimab administered as soon as possible and no later than 3 hours after the start of thrombolysis with tPA (itself administered within 4.5 hrs of the onset of acute ischemic stroke symptoms), and (II) identify the recommended phase 2 dose (RP2D).
During this phase, patients were unevenly randomized between groups, to obtain a total of 60 patients, 12 at each dose level. At the starting level, 8 patients received either glenzocimab at the lowest pharmacologically active dose of 125 mg (n=4) or the matching placebo(n=4). After real-time review by the DSMB of clinical safety and a CT scan (and where available MRI) and giving a favorable opinion, the next patients were randomized in the second cohort (n=8) with 4 patients under a higher dose of 250 mg, 2 patients remaining at the initial starting dose (125 mg), and 2 patients under placebo. Following the same process, and after favorable opinion from the DSMB, patients were randomized in the third cohort (n=10) and received glenzocimab 500 mg (n=4), randomized versus 250 mg (n=2), 125 mg (n=2) or placebo (n=2). Similarly, the fourth cohort (n=12) randomized patients between ahigher dose of 1000 mg (n=4), versus 500 mg (n=2), 250 mg (n=2), 125 mg (n=2), or placebo (n=2). Once this fourth cohort completed, the DSMB issued a further positive opinion and the fifth cohort (n=22) randomized patients to 1000 mg (n=8), versus 500 mg (n=6), 250 mg (n=4), 125 mg (n=2), or placebo (n=2).
Consolidation Phase with Final Dose (Phase 2a):
After having reviewed patient's safety data included in the first part of the study, the DSMB confirmed that the study can continue with the glenzocimab recommended dose of 1000 mg. During this phase, a group of 100 patients will be treated, 50 with glenzocimab and 50 with matching placebo to complete the group of 160 patients planned to participate in this study.
In addition, patients in each treatment arm will be stratified by type of Standard of Care (SOC) administered:
- Thrombolysis with tPA only;
- Thrombolysis with tPA AND mechanical thrombectomy Each treatment arm will contain 25 patients with one SOC, and 25 with the other SOC. The active glenzocimab dose will be that recommended after the last safety analysis has been performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The phase Ib of the study with a sequential design has been achieved (5 arms). The second phase IIa is ongoing. The selected dose (1000mg) for this second part will be compared to placebo (2 arms) with a parallel design.
| Arm | Type | Receives |
|---|---|---|
| Intravenous glenzocimab (ACT017) 1000 mg | Experimental | Drug: Intravenous ACT017 1000 mgIntravenous glenzocimab (ACT017) 1000 mg to be added to a tissue plasminogen activator +/- mechanical thrombectomy |
| Intravenous Placebo | Placebo comparator | Other: Intravenous PlaceboIntravenous Placebo to be added to a tissue plasminogen activator +/- mechanical thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult male or female patients ≥ 18 years (i.e., at least 18 years old at time of randomization). Extreme caution should be exercised in patients over 80 years of age with regards their general health, neurological status and any concomitant diseases and treatments that are likely to be more common;
- Patients who have given written consent, legal representative consent or emergency consent (including e-consent) in accordance with local legal and IECs/IRBs requirements;
- Patients presenting with an acute disabling ischemic stroke in either the anterior or posterior circulation.The time of onset is known or if unknown, the last time the patient was seen well, was at most 4.5 hrs before confirmation of the diagnosis enabling the initiation of alteplase administration within this time-frame;
- Patients presenting at least a NIHSS ≥ 6 prior to thrombolysis with tPA;
- Patients eligible for, or administered thrombolysis treatment with tPA;
Key exclusion criteria (42 listed)
- Coma, and/or NIHSS >25;
- Patients < 18 years of age;
- Prior ischemic stroke within the past 3 months with pre-stroke mRS known to be > 2;
- Baseline CT-scan evaluation: more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline imaging;
- Significant mass effect with midline shift;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous ACT017 1000 mgAlso: Thrombolysis by rtPA +/- thrombectomyAdd-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms | Drug | Intravenous glenzocimab (ACT017) 1000 mg |
| Intravenous PlaceboAlso: Thrombolysis by rtPA +/- thrombectomyAdd-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms | Other | Intravenous Placebo |
Primary outcome
Symptomatic intracranial haemorrhages
Time frame: 24 hours
Number of participants experiencing a symptomatic haemorrhage defined by a secondary increase in National Institute Health Stroke Scale score by 4 points or greater, or death
Incidence of non-symptomatic intracranial haemorrhages
Time frame: 24 hours
Non-symptomatic haemorrhages are those detected by Computerized Tomography scan
14 secondary outcomes
Change from baseline of National Institute Health Stroke Scale score (7 minimum, 42 maximum), brain lesions and vessel recanalization
Time frame: 24 hours
Change from baseline of National Institute Health Stroke Scale score (7 minimum, 42 maximum), brain lesions and vessel recanalization
Time frame: 24 hours
Change from baseline of modified Ranking Scale score assessment
Time frame: Day 90
Change from baseline of modified Ranking Scale score assessment
Time frame: Day 90
Change from baseline on size of infarct zone
Time frame: Day 7
Change from baseline on vital signs
Time frame: 6 hours, 24 hours, Day 7, Day 30 and Day 90
Change from baseline on vital signs
Time frame: 6 hours, 24 hours, Day 7, Day 30 and Day 90
Change from baseline on clinical laboratory assessments
Time frame: Day 90
Change from baseline on clinical laboratory assessments
Time frame: Day 90
Change from baseline on clinical laboratory assessments
Time frame: Day 90
Change from baseline on clinical laboratory assessments
Time frame: Day 90
Change from baseline on ElectroCardioGram (ECG)
Time frame: 24 hours and Day 90
Evidence of anti-ACT017 antibodies (ADA)
Time frame: Day 30 and Day 90
Pharmacokinetics on ACT017 plasma concentration
Time frame: 30 minutes, 9 hours and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 31017822Voors-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: PubMed 32500636Renaud 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.
- Derived from this study: PubMed 42044230Kohrmann 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.
- Derived from this study: PubMed 38267188Mazighi 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.
- Quality and cost assessment of a recombinant antibody fragment produced from mammalian, yeast and prokaryotic host cells: A case study prior to pharmaceutical developmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Comenducci, MD study director
Acticor Biotech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous ACT017 1000 mg in people with Acute Ischemic Stroke, run by Acticor Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic intracranial haemorrhages (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803007, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.