A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS).

Official Title
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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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Biological: Redasemtide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Redasemtide Dose A<br>Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization. | Biological: Redasemtide<br>* Lyophilized white powder reconstituted in 0.9% saline for injection<br>* Other names: S-005151;|
| Experimental: Redasemtide Dose B<br>Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization. | Biological: Redasemtide<br>* Lyophilized white powder reconstituted in 0.9% saline for injection<br>* Other names: S-005151;|
| Placebo Comparator: Placebo<br>Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization. | Drug: Placebo<br>* Lyophilized white powder reconstituted in 0.9% saline for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) Score at Day 90 |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With mRS Score of 0 to 2 |  | Day 90 | 
| Number of Participants With Barthel Index (BI) Score ≥ 95 |  | Day 90 | 
| mRS Score at Day 30 |  | Day 30 | 
| mRS Score at Day 180 |  | Day 180 | 
| Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1 |  | Days 1, 5, 30, 90, and 180 | 
| Change From Baseline in NIHSS Score |  | Baseline, Days 1, 5, 30, 90, and 180 | 
| Number of Participants With BI Score ≥ 95 |  | Days 5, 30, 90, and 180 | 
| Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score |  | Day 5, Days 90 and 180 | 
| Change From Day 5 in Stroke and Aphasia Quality of Life Scale - 39 Item Generic Version (SAQoL-39g) Score |  | Day 5, Days 90 and 180 | 
| Patient Global Impression of Change Scale (PGI-C) Score |  | Days 5, 90, and 180 | 
| Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score |  | Day 5, Days 90 and 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Redasemtide, S-005151, Plasminogen activator, Thrombectomy