Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03803007
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2018-12-12
Brief Title:
Acute Ischemic Stroke Interventional Study
Sponsor:
Acticor Biotech
Organization:
Acticor Biotech
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTIMIS
Brief 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 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 45 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 n4 or the matching placebon4 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 n8 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 n10 and received glenzocimab 500 mg n4 randomized versus 250 mg n2 125 mg n2 or placebo n2 Similarly the fourth cohort n12 randomized patients between ahigher dose of 1000 mg n4 versus 500 mg n2 250 mg n2 125 mg n2 or placebo n2 Once this fourth cohort completed the DSMB issued a further positive opinion and the fifth cohort n22 randomized patients to 1000 mg n8 versus 500 mg n6 250 mg n4 125 mg n2 or placebo n2
Consolidation Phase with Final Dose Phase 2a
After having reviewed patients 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
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 45 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 n4 or the matching placebon4 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 n8 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 n10 and received glenzocimab 500 mg n4 randomized versus 250 mg n2 125 mg n2 or placebo n2 Similarly the fourth cohort n12 randomized patients between ahigher dose of 1000 mg n4 versus 500 mg n2 250 mg n2 125 mg n2 or placebo n2 Once this fourth cohort completed the DSMB issued a further positive opinion and the fifth cohort n22 randomized patients to 1000 mg n8 versus 500 mg n6 250 mg n4 125 mg n2 or placebo n2
Consolidation Phase with Final Dose Phase 2a
After having reviewed patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002855-13 | EUDRACT_NUMBER | None | None |