NCT05953480

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
BIOLOGICAL	Redasemtide	Lyophilized white powder reconstituted in 0.9% saline for injection
DRUG	Placebo	Lyophilized white powder reconstituted in 0.9% saline for injection

Timeline

• Start date: 2023-07-14
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-07-20
• Last updated: 2026-02-03

Locations

150 sites across 17 countries: United States, Australia, Belgium, China, Czechia, Finland, Germany, Greece, Hong Kong, Hungary, Israel, Japan, Serbia, Singapore, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study