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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05953480




Registration number
NCT05953480
Ethics application status
Date submitted
12/07/2023
Date registered
20/07/2023
Date last updated
5/06/2024

Titles & IDs
Public title
A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke
Scientific title
A Phase 2b, Multinational, Randomized, Double-blind Study to Investigate the Efficacy and Safety of Redasemtide (S-005151) Compared With Placebo in Adult Participants With Acute Ischemic Stroke Who Are Not Eligible for Tissue Pasminogen Activator or Thrombectomy
Secondary ID [1] 0 0
2022-501890-38-00
Secondary ID [2] 0 0
2138P2231
Universal Trial Number (UTN)
Trial acronym
REvive
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Redasemtide
Treatment: Drugs - Placebo

Experimental: Redasemtide Dose A - Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.

Experimental: Redasemtide Dose B - Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.

Placebo Comparator: Placebo - Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization.


Other interventions: Redasemtide
Lyophilized white powder reconstituted in 0.9% saline for injection

Treatment: Drugs: Placebo
Lyophilized white powder reconstituted in 0.9% saline for injection
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Rankin Scale (mRS) Score at Day 90
Timepoint [1] 0 0
Day 90
Secondary outcome [1] 0 0
Number of Participants With mRS Score of 0 to 2
Timepoint [1] 0 0
Day 90
Secondary outcome [2] 0 0
Number of Participants With Barthel Index (BI) Score = 95
Timepoint [2] 0 0
Day 90
Secondary outcome [3] 0 0
mRS Score at Day 30
Timepoint [3] 0 0
Day 30
Secondary outcome [4] 0 0
mRS Score at Day 180
Timepoint [4] 0 0
Day 180
Secondary outcome [5] 0 0
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1
Timepoint [5] 0 0
Days 1, 5, 30, 90, and 180
Secondary outcome [6] 0 0
Change From Baseline in NIHSS Score
Timepoint [6] 0 0
Baseline, Days 1, 5, 30, 90, and 180
Secondary outcome [7] 0 0
Number of Participants With BI Score = 95
Timepoint [7] 0 0
Days 5, 30, 90, and 180
Secondary outcome [8] 0 0
Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score
Timepoint [8] 0 0
Day 5, Days 90 and 180
Secondary outcome [9] 0 0
Change From Day 5 in Stroke and Aphasia Quality of Life Scale - 39 Item Generic Version (SAQoL-39g) Score
Timepoint [9] 0 0
Day 5, Days 90 and 180
Secondary outcome [10] 0 0
Patient Global Impression of Change Scale (PGI-C) Score
Timepoint [10] 0 0
Days 5, 90, and 180
Secondary outcome [11] 0 0
Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score
Timepoint [11] 0 0
Day 5, Days 90 and 180

Eligibility
Key inclusion criteria
- Able to initiate study intervention within 25 hours of stroke onset

- Determined by the investigator to not be eligible for recanalization thrombolysis or
endovascular recanalization therapy (that is, mechanical thrombectomy, local
fibrinolytic therapy) for the current stroke.

- Baseline NIHSS score of 8 to 22 (inclusive) and stable, defined as absence of an
increase or decrease of = 4 points within = 1 hour to = 3 hours between screening and
baseline assessment of NIHSS score.

- Medically stable at the time of enrollment except for primary disease and
complications associated with it, according to the judgment of the investigator. In
addition, hospitalization during the Follow-up Period is not anticipated, and the
participant appears likely to be able to complete the study. Medically stable is
defined as disease not requiring significant change in therapy for 3 months following
enrollment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any disease or neurological disorder that, in the opinion of the investigator, would
interfere with the conduct of the study

- A severe decrease in consciousness level (defined as NIHSS item 1a score 3: Not alert,
responds only with reflex motor or autonomic effects, or totally unresponsive,
flaccid, and areflexic)

- Disability corresponding to a mRS score of = 2 before the onset of stroke

- A history of stroke (excluding transient ischemic attack), history of or current
intracranial hemorrhage, or head trauma that caused neurological effects within 90
days prior to obtaining informed consent

- Participants with an ischemic stroke in cerebellum and/or brain stem as the main
infarction site

- Diagnosis of a current transient ischemic attack

- Unable to undergo either CT or MRI

- Considered by the investigator to be inappropriate to participate due to a history or
complication of serious cardiovascular disease within 1 month of screening (for
example, history of acute myocardial infarction, current acute myocardial infarction,
uncontrollable heart failure, infective endocarditis requiring treatment, or acute
aortic dissection, or requiring or likely to require hospitalization for severe
arrhythmia during the study)

- Blood glucose level < 50 or > 400 milligrams/deciliter after glycemic control

- Systolic blood pressure = 220 millimeters of mercury (mmHg) or diastolic blood
pressure = 120 mmHg after antihypertensive treatment

- Sensitivity to any of the study interventions, or components thereof, or clinically
significant drug or other severe allergy that, in the opinion of the investigator,
contraindicates participation in the study

- Use of prohibited concomitant medications or therapies listed in the protocol for the
treatment of current AIS

- Participants who have previously received redasemtide

- Participants who have received any investigational product within 90 days of screening

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
627
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - PPDS - Sydney
Recruitment postcode(s) [1] 0 0
2170 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Hong Kong
State/province [9] 0 0
New Territories
Country [10] 0 0
Israel
State/province [10] 0 0
HaDarom
Country [11] 0 0
Israel
State/province [11] 0 0
HaMerkaz
Country [12] 0 0
Israel
State/province [12] 0 0
HaZafon
Country [13] 0 0
Israel
State/province [13] 0 0
Tel-Aviv
Country [14] 0 0
Israel
State/province [14] 0 0
Yerushalayim
Country [15] 0 0
Israel
State/province [15] 0 0
Ashkelon
Country [16] 0 0
Israel
State/province [16] 0 0
Haifa
Country [17] 0 0
Israel
State/province [17] 0 0
Ramat-Gan
Country [18] 0 0
Israel
State/province [18] 0 0
Safed
Country [19] 0 0
Japan
State/province [19] 0 0
Chiba
Country [20] 0 0
Japan
State/province [20] 0 0
Gifu
Country [21] 0 0
Japan
State/province [21] 0 0
Hiroshima
Country [22] 0 0
Japan
State/province [22] 0 0
Hyôgo
Country [23] 0 0
Japan
State/province [23] 0 0
Kanagawa
Country [24] 0 0
Japan
State/province [24] 0 0
Sizuoka
Country [25] 0 0
Japan
State/province [25] 0 0
Tokyo
Country [26] 0 0
Japan
State/province [26] 0 0
Yamagata
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi
Country [28] 0 0
Japan
State/province [28] 0 0
Fukui
Country [29] 0 0
Japan
State/province [29] 0 0
Fukuoka
Country [30] 0 0
Japan
State/province [30] 0 0
Hokkaido
Country [31] 0 0
Japan
State/province [31] 0 0
Hyogo
Country [32] 0 0
Japan
State/province [32] 0 0
Ibaraki
Country [33] 0 0
Japan
State/province [33] 0 0
Oita
Country [34] 0 0
Japan
State/province [34] 0 0
Osaka
Country [35] 0 0
Japan
State/province [35] 0 0
Saitama
Country [36] 0 0
Japan
State/province [36] 0 0
Shimane
Country [37] 0 0
Japan
State/province [37] 0 0
Shizuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Ôsaka

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shionogi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult
participants with acute ischemic stroke (AIS).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05953480
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shionogi Clinical Trials Administrator Clinical Support Help Line
Address 0 0
Country 0 0
Phone 0 0
1-800-849-9707
Fax 0 0
Email 0 0
Shionogiclintrials-admin@shionogi.co.jp
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05953480