ACTIVE_NOT_RECRUITING

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

Conditions

Acute Ischemic Stroke Redasemtide S-005151 Plasminogen activator Thrombectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS). This study consists of 2 cohorts, Cohort A and Cohort B. Cohort A (redasemtide or placebo) will enroll participants who are ineligible for systemic thrombolysis and/or mechanical recanalization therapy. Cohort B (redasemtide or placebo) will enroll participants who are eligible to receive or who have received systemic thrombolysis and/or mechanical recanalization therapy as standard of care.

Official 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

Quick Facts

Study Start:2023-07-14

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05953480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Able to initiate study intervention within 25 hours of stroke onset * Cohort A: Determined by the investigator to not be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke. * Cohort B: Determined by the investigator to be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke. * Cohort A: If a participant is not eligible for systemic thrombolysis and/or mechanical recanalization therapy, screening and baseline NIHSS score of 6 to 22 is required (inclusive) and must be stable, defined as absence of an increase or decrease of ≥4 points within ≥1 hour to ≤3 hours of screening, and NIHSS score should be 6 to 22 at baseline. * Cohort B: In a participant who is eligible to receive or has received concomitant systemic thrombolysis and/or mechanical recanalization therapy, the NIHSS score must be 6 to 22 at screening prior to systemic thrombolysis and/or mechanical recanalization therapy and the second/baseline NIHSS score must be 6 to 22 and should be done after systemic thrombolysis and/or mechanical recanalization therapy. * 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.	* 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 computed tomography or magnetic resonance imaging * 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

Inclusion Criteria

Exclusion Criteria

* Able to initiate study intervention within 25 hours of stroke onset
* Cohort A: Determined by the investigator to not be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke.
* Cohort B: Determined by the investigator to be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke.
* Cohort A: If a participant is not eligible for systemic thrombolysis and/or mechanical recanalization therapy, screening and baseline NIHSS score of 6 to 22 is required (inclusive) and must be stable, defined as absence of an increase or decrease of ≥4 points within ≥1 hour to ≤3 hours of screening, and NIHSS score should be 6 to 22 at baseline.
* Cohort B: In a participant who is eligible to receive or has received concomitant systemic thrombolysis and/or mechanical recanalization therapy, the NIHSS score must be 6 to 22 at screening prior to systemic thrombolysis and/or mechanical recanalization therapy and the second/baseline NIHSS score must be 6 to 22 and should be done after systemic thrombolysis and/or mechanical recanalization therapy.
* 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.

* 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 computed tomography or magnetic resonance imaging
* 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

Contacts and Locations

Study Locations (Sites)

Banner University of Arizona Medical Center

Tucson, Arizona, 85724

United States

Intercoastal Medical Group

Sarasota, Florida, 34239-3228

United States

Augusta University

Augusta, Georgia, 30912-0004

United States

Mercyhealth Javon Bea Hospital- Riverside

Rockford, Illinois, 61114-2300

United States

Community Hospital

Munster, Indiana, 46321-2901

United States

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215-5216

United States

Munson Healthcare

Traverse City, Michigan, 49684

United States

Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDS

Rochester, Minnesota, 55905-0001

United States

North Shore University Hospital-300 Community Dr

Manhasset, New York, 11030-3816

United States

Nuvance Health Medical Practice, PC- Neurosurgery

Poughkeepsie, New York, 12601-3986

United States

Summa Health System - Akron Campus

Akron, Ohio, 44304

United States

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210-1240

United States

Ascension St. John Clinical Research Institute

Tulsa, Oklahoma, 74104-5437

United States

Baylor University Medical Center - 3500 Gaston Ave

Dallas, Texas, 75246

United States

Houston Methodist Hospital

Houston, Texas, 77030-2726

United States

Baylor Scott & White - Plano Brain & Spine Center

Plano, Texas, 75093-5338

United States

University Health-University Hospital

San Antonio, Texas, 78229-3931

United States

Collaborators and Investigators

Sponsor: Shionogi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-14

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-07-14

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

Redasemtide
S-005151
Plasminogen activator
Thrombectomy

Additional Relevant MeSH Terms

Acute Ischemic Stroke