A phase 2b, randomized, double-blind study of redasemtide (S-005151) in adult participants with acute ischemic stroke

Phase 1

Recruiting

Conditions: acute ischemic stroke
MedDRA version: 22.1Level: PTClassification code: 10061256Term: Ischaemic stroke Class: 100000004852
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2022-501890-38-00

Lead Sponsor: Shionogi B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 524

Inclusion Criteria

Male or female adults = 18 years of age (or complies with country-specific regulatory requirements) at the time of obtaining informed consent, Capable of giving signed informed consent as described in the ICF that includes compliance with the national requirements and the requirements and restrictions listed in the ICF and in this protocol. If the participant cannot provide consent, consent from the participant’s proxy/legally authorized representative (LAR) is allowed according to local regulations. Note: Country-specific rules and local Ethics Committee approval for proxy/LAR will determine whether or not and how a participant unable to comprehend or sign the ICF is allowed to be enrolled in the study., Diagnosis of supratentorial (including anterior and posterior circulation) ischemic stroke as the main infarction site, confirmed by computed tomography (CT) scan or magnetic resonance imaging (MRI) at the time of screening. The CT imaging criteria are hypodensity, perfusion deficit, or vessel occlusion in the anterior or posterior circulation., Able to initiate study intervention within 25 hours of stroke onset (if the onset time is unknown, the last time at which the participant was known to be healthy is regarded as the onset time [last known to be well”]), Determined by the investigator to not be eligible for recanalization thrombolysis or endovascular recanalization therapy (ie, mechanical thrombectomy, local fibrinolytic therapy) for the current stroke. (Note: Participants who underwent mechanical thrombectomy, but a stent could not be placed to reach the occluded vessel site may be eligible for this study.) Please refer to the most recent tPA package insert for contraindications. For every randomised participant, the investigator should complete the Participant Hospitalization Sheet (see Section 8) prior to randomization, including the reason for the participant not being eligible for thrombolytic therapy., 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), Body weight of = 30 to = 150 kg, A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) Is a woman of nonchildbearing potential (WONCBP) as defined in Section 10.4.1 (Appendix 4) OR b) Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method as described in Section 10.4.2 (Appendix 4) during the 5-day Treatment Period. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. A WOCBP (defined in Section 10.4.1 [Appendix 4]) must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In suc

Exclusion Criteria

Any disease or neurological disorder that, in the opinion of the investigator, would interfere with the conduct of the study, Systolic blood pressure = 220 mm Hg or diastolic blood pressure = 120 mm Hg after antihypertensive treatment, Any malignant tumor except nonmelanoma skin cancer or lesions equivalent to intramucosal cancer or carcinoma in situ curable by endoscopic resection. OR if the participant with a malignant tumor is undergoing or has completed systemic anti-cancer treatment (chemotherapy, immunotherapy) or radiotherapy within 1 month prior to Screening and is not medically stable based on the assessment of the investigator, 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 Section 6.8 for the treatment of current AIS, Participants who have previously received redasemtide, Participants who have received any investigational product within 90 days of Screening, 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 (eg, 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 mg/dL after glycemic control

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of redasemtide with that of placebo;Secondary Objective: To evaluate the safety and tolerability of redasemtide;Primary end point(s): mRS score at Day 90

Secondary Outcome Measures

Name	Time	Method

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