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

Phase 1

Conditions: Acute ischemic stroke
MedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2021-002148-56-DE

Lead Sponsor: ACTICOR BIOTECH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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, and in any case, in strict accordance with country-specific 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 = 6,
5. In whom IVT is or has been initiated, whether or not patients are additionally eligible to mechanical thrombectomy (MT + IVT), according to the last recommendations of the last guidelines (ASA and ESO recommendations)
6. Women of childbearing potential (WOCBP) must have a negative serum/urine pregnancy test at baseline. Women of childbearing
potential, i.e., fertile, are defined as women following menarche and until becoming post-menopausal unless permanently sterile, i.e.,
having undergone hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
7. 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:
-combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (intravaginal, transdermal),
-progestogen-only hormonal contraception associated with inhibition of ovulation (injectable, implantable)
-intrauterine device (IUD),
-intrauterine hormone-releasing system (IUS),
-bilateral tubal occlusion,
-vasectomized partner.
Birth control methods which may be considered as highly effective for men and that should last for 4 months after IMP administration include:
- vasectomy,
- use of condom combined with a highly effective birth control method for their WOCBP partner.
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.
8. Patients affiliated to a health insurance – modality depending on country legal requirement
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 133
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 267

Exclusion Criteria

1. Coma, or NIHSS >25,
2. Patients < 18 years,
3. Protected adults under guardianship or curatorship,
4. Prior ischemic stroke within the past 3 months,
5. mRS pre-stroke known to be = 2,
6. Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on Baseline Computed Tomography Angiography (CTA) or Magnetic Resonance Imaging (MRI) or with vascular injection (MRA),
7. Significant mass effect with midline shift,
8. Stroke of hemorrhagic origin,
9. Patients likely to require dual antiplatelet therapy (DAPT) within the first 24 hrs after cessation of glenzocimab or placebo infusion for
e.g., carotid stenting,
10. Known renal insufficiency (Grades 4-5 – severe or terminal), with a creatinine clearance < 30 mL/Mn using Cockroft formula)
11. Known allergic reaction to contrast agents,
12. Patients under anti-coagulant therapy, except preventative doses of injectable low molecular weight heparin (LMWH),
13. Known ongoing treatment with a mAb,
14. Prior cardiopulmonary resuscitation < 10 days,
15. Childbirth within < 10 days,
16. Seizures at stroke onset if it precludes obtaining an accurate baseline (pre-IVT) NIHSS,
17. Life expectancy (except for stroke) < 3 months,
18. Pregnancy or breastfeeding,
19. Females of childbearing potential not using effective birth control methods,
20. Known current participation in another clinical investigation with experimental drug