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

Summary

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.

Timeline

Start

2023-07-14

Primary completion

2026-06-30

Completion

2026-06-30

Outcome

Missed primary endpoint

release “redasemtide group did not show a statistically significant improvement compared with the placebo group, and this trial did not achieve its primary endpoint.” shionogi.com ↗

Drugs

Indications