Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001353381p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
15/10/2026
Date registered
Help: Date registered
10/11/2026
Date last updated
Help: Date last updated
10/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/11/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Dose-Selection Clinical Trial to Evaluate the Efficacy and Safety of ARG-007 in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion Undergoing Endovascular Thrombectomy
Scientific title
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Dose-Selection Clinical Trial to Evaluate the Efficacy and Safety of ARG-007 in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion Undergoing Endovascular Thrombectomy
Additional trial identifiers [1] 318635 0
ARG-007-003
Universal Trial Number (UTN)
Trial acronym
PROTECT
Related trial records

Health condition
Health condition(s) studied:
Stroke, acute 343846 0
Condition category
Condition code
Stroke 339987 339987 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1: ARG-007 (xaranetide) 1.5 mg/mL
Arm 2: ARG-007 (xaranetide) 3.0 mg/mL
Arm 3: placebo (vehicle)

Investigational product administered as a single intravenous infusion over 10 minutes in hospital by registered nurse. Participants will be administered investigational products as soon as possible after randomisation but before completion of endovascular revascularisation (using mechanical thrombectomy, with or without thrombolysis).

Participants will be followed up in hospital on Day, 2, Day 3 and Day 6 (or Discharge). Safety assessments including vital signs, National Institutes of Health Stroke Scale (NIHSS) and laboratory tests will be carried out during these visits. Additionally, a non-contrast computed tomography (NCCT) will be performed at Day 2 and a magnetic resonance imaging (MRI) scan will be performed on Day 3.

Following discharge, participants will be followed up by telephone or video call on Day 30 and Day 90 (end of trial). Questionnaires will be collected during these visits to assess safety and efficacy.
Intervention code [1] 335543 0
Treatment: Drugs
Description of the comparator or control
Placebo comparator - normal saline. There are no difference in procedures, activities and/or processes between the intervention and placebo group
Control group
Placebo

Outcomes
Primary outcome [1] 347151 0
To evaluate the effect of ARG-007 on clinically meaningful functional outcomes at Day 90
Timepoint [1] 347151 0
Day 90 post intervention
Secondary outcome [1] 469174 0
To evaluate the effect of ARG-007 on early neurological recovery in the acute post-reperfusion period
Timepoint [1] 469174 0
Day 2 and Day 6 post intervention (or day of discharge from hospital)
Secondary outcome [2] 469175 0
To evaluate the effect of ARG-007 on functional independence in activities of daily living
Timepoint [2] 469175 0
Day 90 post intervention

Eligibility
Key inclusion criteria
1. Diagnosis of acute ischaemic stroke (AIS) deemed suitable for endovascular revascularisation (mechanical thrombectomy with or without a thrombolytic agent).
2. Imaging confirmed anterior circulation large vessel occlusion (LVO) involving the internal carotid artery (ICA) or proximal (M1) or insular segment (M2) middle cerebral artery (MCA), as assessed by computed tomography angiography (CTA), and deemed suitable for endovascular thrombectomy (EVT) by the treating physician.
3. Males and females >=18 years of age at the time of informed consent.
4. Stroke onset (last known well) time >= 6 points at time of randomisation.
6. Pre-stroke mRS 0-1. Participant must be living without requiring nursing care.
7. ASPECTS of 3-8 in 1 cortical region as determined by the investigator, with AI-assisted support for standardisation and accuracy, or a baseline infarct volume >= 20 and <=150 mL.
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 trial.
9. Willing (participant and/or caregiver) to commit to follow-up assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.
2. Documented angiographic or imaging evidence that the target occluded vessel has reperfused prior to administration of investigational product (IP).
3. Rapid spontaneous improvement of neurological deficits before administration of IP, such that, in the opinion of the Investigator, the participant no longer has a persistent disabling stroke deficit or is no longer an appropriate candidate for endovascular thrombectomy (EVT).
4. Uncontrolled blood pressure (BP) >= 180/110 mmHg or < 90/60 mmHg before EVT procedure is initiated.
5. Severe known renal impairment, defined as requiring dialysis (hemo- or peritoneal) or a known creatinine clearance < 29 mL/min.
6. History of stroke (ischaemic, haemorrhagic, or transient).
7. Known history of hypoparathyroidism or parathyroidectomy.
8. History or current use of anti-amyloid therapy within 6 months of enrolment
9. Estimated or known body weight 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, degenerative or fatal comorbid illness that will prevent improvement or follow-up.
12. Active cancer or a history of malignancy likely to interfere with survival during the clinical trial period.
13. Clinical history, imaging or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
14. Planned use of an endovascular device that is not approved or does not have clearance by the relevant regulatory authority.
15. In the opinion of the Investigator, participant is unlikely to 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.
16. Participation in another interventional clinical trial involving an investigational medicinal product or device within 30 days or 5 half-lives, whichever is longer, prior to enrolment. Participation in observational studies, registries or non-interventional device registry studies that do not alter standard clinical management is permitted.
17. 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 trial, or the outcome of the trial.

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)
Central randomisation by Invoice Web Response System.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2027
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 30348 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 30349 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 30350 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 30351 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 30352 0
The Alfred - Melbourne
Recruitment hospital [6] 30353 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 30354 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 30355 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 46765 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 46766 0
3050 - Parkville
Recruitment postcode(s) [3] 46767 0
6009 - Nedlands
Recruitment postcode(s) [4] 46768 0
6150 - Murdoch
Recruitment postcode(s) [5] 46769 0
3004 - Melbourne
Recruitment postcode(s) [6] 46770 0
5000 - Adelaide
Recruitment postcode(s) [7] 46771 0
2170 - Liverpool
Recruitment postcode(s) [8] 46772 0
2305 - New Lambton
Recruitment outside Australia
Country [1] 28635 0
United States of America
State/province [1] 28635 0

Funding & Sponsors
Funding source category [1] 323211 0
Commercial sector/Industry
Name [1] 323211 0
Argenica Therapeutics Ltd
Country [1] 323211 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Argenica Therapeutics Ltd
Address
Country
Australia
Secondary sponsor category [1] 326180 0
None
Name [1] 326180 0
Address [1] 326180 0
Country [1] 326180 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321609 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 321609 0
Ethics committee country [1] 321609 0
Australia
Date submitted for ethics approval [1] 321609 0
17/11/2026
Approval date [1] 321609 0
Ethics approval number [1] 321609 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 154250 0
Dr Michael Devlin
Address 154250 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba Queensland 4102
Country 154250 0
Australia
Phone 154250 0
+61 417 729 278
Fax 154250 0
Email 154250 0
[email protected]
Contact person for public queries
Name 154251 0
Sharon Hanegraaf
Address 154251 0
Argenica Therapeutics, 4/117 Broadway Nedlands WA 6009/ PO Box 1458, West Perth WA 6872
Country 154251 0
Australia
Phone 154251 0
+61 8 9329 3396
Fax 154251 0
Email 154251 0
[email protected]
Contact person for scientific queries
Name 154252 0
Sharon Hanegraaf
Address 154252 0
Argenica Therapeutics, 4/117 Broadway Nedlands WA 6009/ PO Box 1458, West Perth WA 6872
Country 154252 0
Australia
Phone 154252 0
+61 8 9329 3396
Fax 154252 0
Email 154252 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.