Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001110673
Ethics application status
Approved
Date submitted
24/09/2023
Date registered
25/10/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
25/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase II, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study to Determine the Safety, Preliminary Efficacy, and Pharmacokinetics of ARG-007 in Acute Ischemic Stroke Patients
Scientific title
A Phase II, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study to Determine the Safety, Preliminary Efficacy, and Pharmacokinetics of ARG-007 in Acute Ischemic Stroke Patients
Secondary ID [1] 309690 0
Nil
Universal Trial Number (UTN)
Trial acronym
SEANCON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 330066 0
Acute 331700 0
Condition category
Condition code
Stroke 326967 326967 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARG-007
Experimental: ARG-007 - Single intravenous infusion of ARG-007 0.3 mg/kg over 10 minutes, administered in hospital by registered nurse. Participants are to be administered the ARG-007 as soon after randomization as possible but before the completion of endovascular revascularization (using mechanical thrombectomy with or without thrombolysis).

Participants will be followed up in hospital on Day 2, Day 3, Day 6 (or Discharge), Safety assessments including vital signs, NIHSS and laboratory will be carried out during these visits. Additionally, an NCCT will be performed at day 2 and an MRI at day 3.

Following discharge participants will be followed up by telephone on Day 30, and Day 90 (End of Study [EoS]). Questionnaires will be collected during these visits to assess safety & efficacy.
Intervention code [1] 326132 0
Treatment: Drugs
Comparator / control treatment
Saline Placebo
There are no differences in procedures, activities, and/or processes between the intervention and placebo group.
Control group
Placebo

Outcomes
Primary outcome [1] 334803 0
To evaluate the safety of a single dose of ARG-007 in participants with acute ischemic stroke (AIS).
The primary analyses will be mortality rate and frequency of AEs/SAEs.
Site personnel will collect AE information from participants. Open-ended
and nonleading questions will be used to enquire about any AEs/SAEs.
Timepoint [1] 334803 0
Day 1, Day 2, Day 3, Day 6 or Discharge, Day 30 and Day 90 (Primary timepoint).
Secondary outcome [1] 422346 0
The efficacy analysis is the difference in infarct volume between the ARG-007 and placebo groups as measured by MRI (or NCCT if MRI is not available) at 48 hours (Day 3 ± 1 day).
Timepoint [1] 422346 0
Day 3 post-intervention.

Eligibility
Key inclusion criteria
1) Diagnosis of AIS deemed suitable for endovascular revascularization (mechanical thrombectomy with or without a thrombolytic agent).

2) Aged >/= 18 years.

3) Stroke onset (last known well) time < /= 24 hours before randomization.

4) The National Institutes of Health Stroke Scale (NIHSS) >/= 5 points at time of randomization.

5) Pre-stroke modified Rankin Score (mRS) < /= 3. Participant must have been living in their own home, apartment, or a senior’s lodge where no nursing care is required.

6) Confirmed symptomatic intracranial occlusion, based on computed tomographic angiography (CTA), at one or more of the following locations: intracranial internal carotid artery (T/L morphology) or M1 middle cerebral artery.

7) For participants transferring to stroke center from another hospital, CTA for study eligibility is to be performed or repeated at stroke center with endovascular suite onsite if there is a long delay (> 6 hours) from time of first CTA to time of repeat CTA.

8) Signed informed consent from participant or their legally authorized representative, or if required to enable inclusion by applicable national laws and regulations and the applicable Institutional Review Board/Ethics Committee requirements for obtaining consent from the investigator after consultation with an independent physician who is not otherwise participating in the study.

9) Willing (participant and/or caretaker) to commit to follow up assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Evidence of a large core of established infarction defined as ASPECTS of 0 to 5.

2) Evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.

3) Endovascular revascularization procedure has already been completed at the time of Screening/randomization or has been completed before administration of study drug.

4) Planned use of an endovascular device that is not approved or does not have clearance by the relevant regulatory authority.

5) Rapid spontaneous improvement of neurological signs during Screening, as defined by a reduction of >/= 8 on the NIHSS between onset of symptoms and randomization.

6) History of stroke (ischemic or hemorrhagic) or penetrating head injury within 90 days before enrollment.

7) Uncontrolled blood pressure (BP) >/= 180/110 mmHg before endovascular revascularization procedure is initiated.

8) No femoral pulses, very difficult endovascular access, or extreme tortuosity of the great vessels that is predicted to result in an inability to timely deliver endovascular therapy. Direct common carotid or radial/brachial/axillary access is permissible.

9) Estimated or known body weight < 45 kg or > 130 kg.

10) Pregnancy: If a woman is of childbearing potential and has a positive point-of-care urine beta-human chorionic gonadotropin (ß-HCG) test or is breastfeeding.

11) Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or a creatinine clearance < 29 mL/min.

12) Severe or fatal comorbid illness that will prevent improvement or follow-up.

13) Cannot complete follow-up visits because participant is a visitor to the area, or any other known reason that would prevent attendance at follow-up visits.

14) Received treatment with an investigational drug or device within 30 days before enrollment.

15) Any other condition that, in the opinion of the investigator, may adversely affect the safety of the participant, the participant’s ability to complete the study, or the outcome of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/03/2024
Actual
28/03/2024
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
92
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 24857 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 24858 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 24859 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 24860 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 24861 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 24862 0
John Hunter Hospital - New Lambton
Recruitment hospital [7] 24863 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 25078 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [9] 26371 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [10] 26372 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 40505 0
5000 - Adelaide
Recruitment postcode(s) [2] 40506 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 40507 0
3168 - Clayton
Recruitment postcode(s) [4] 40508 0
6150 - Murdoch
Recruitment postcode(s) [5] 40509 0
6009 - Nedlands
Recruitment postcode(s) [6] 40510 0
2305 - New Lambton
Recruitment postcode(s) [7] 40511 0
2170 - Liverpool
Recruitment postcode(s) [8] 40748 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [9] 42343 0
4029 - Herston
Recruitment postcode(s) [10] 42344 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 313938 0
Commercial sector/Industry
Name [1] 313938 0
Argenica Therapeutics Ltd
Country [1] 313938 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Argenica Therapeutics Ltd
Address
4/117 BroadwayNedlands WA 6009, Australia
Country
Australia
Secondary sponsor category [1] 315897 0
None
Name [1] 315897 0
Address [1] 315897 0
Country [1] 315897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313031 0
St. Vincent’s Hospital (Melbourne) Human Research Ethics Committee
Ethics committee address [1] 313031 0
41 Victoria Parade, Fitzroy, VIC 3065
Ethics committee country [1] 313031 0
Australia
Date submitted for ethics approval [1] 313031 0
18/07/2023
Approval date [1] 313031 0
11/09/2023
Ethics approval number [1] 313031 0

Summary
Brief summary
The primary purpose of this single dose study is to assess the safety and preliminary efficacy of ARG-007 in participants with AIS undergoing endovascular revascularization.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126746 0
Prof Graeme Hankey
Address 126746 0
Perron Institute Chair in Stroke Research, RR Block, QE II Medical Centre, 8 Verdun St, Nedlands, WA 6009
Country 126746 0
Australia
Phone 126746 0
+61 8 6151 0828
Fax 126746 0
Email 126746 0
[email protected]
Contact person for public queries
Name 126747 0
Dr Meghan Thomas
Address 126747 0
Argenica Therapeutics Ltd, 4/117 Broadway Nedlands WA 6009, Australia PO Box 1458, West Perth WA 6872
Country 126747 0
Australia
Phone 126747 0
+61 8 9329 3396
Fax 126747 0
Email 126747 0
[email protected]
Contact person for scientific queries
Name 126748 0
Dr Meghan Thomas
Address 126748 0
Argenica Therapeutics Ltd, 4/117 Broadway Nedlands WA 6009, Australia. PO Box 1458, West Perth WA 6872
Country 126748 0
Australia
Phone 126748 0
+61 8 9329 3396
Fax 126748 0
Email 126748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.