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

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ClinicalTrials.gov Identifier: NCT05953480
Recruitment Status : Recruiting
First Posted : July 20, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

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

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Biological: Redasemtide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 627 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Who Are Not Eligible for Tissue Pasminogen Activator or Thrombectomy
Actual Study Start Date : July 14, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Redasemtide Dose A
Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.
 Biological: Redasemtide
Lyophilized white powder reconstituted in 0.9% saline for injection
Other Names:
  • Redasemtide trifluoroacetate
  • S-005151
Experimental: Redasemtide Dose B
Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.
 Biological: Redasemtide
Lyophilized white powder reconstituted in 0.9% saline for injection
Other Names:
  • Redasemtide trifluoroacetate
  • S-005151
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.
 Drug: Placebo
Lyophilized white powder reconstituted in 0.9% saline for injection


Outcome Measures
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Primary Outcome Measures :
  1. Modified Rankin Scale (mRS) Score at Day 90 [ Time Frame: Day 90 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05953480


Contacts
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Contact: Shionogi Clinical Trials Administrator Clinical Support Help Line 1-800-849-9707 Shionogiclintrials-admin@shionogi.co.jp

Locations
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Sponsors and Collaborators
Shionogi
More Information
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Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT05953480    
Other Study ID Numbers: 2138P2231
2022-501890-38-00 ( Registry Identifier: Clinical Trials Information System (CTIS) )
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shionogi Inc. ( Shionogi ):
Redasemtide
S-005151
Plasminogen activator
Thrombectomy
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis