NCT06990867

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Optimizing Reperfusion to Improve Outcomes and Neurologic Function (ORION): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of JX10 in Acute Ischemic Stroke With Late Presentations

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 740 (estimated)
• Sponsor: Corxel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours. The main question the study aims to answer are: 1. JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS. 2. Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS. During Part 1, participants will be randomized to JX 10 (1mg/kg, 3 mg/kg) or placebo. During Part 2, participants will receive JX10 (optimal dose chosen from Part 1) or placebo.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	JX10	JX10 is a thrombolytic agent.
DRUG	Placebo	Placebo is being used as the comparator.

Timeline

• Start date: 2025-05-15
• Primary completion: 2029-10-31
• Completion: 2029-12-31
• First posted: 2025-05-25
• Last updated: 2026-03-13

Locations

83 sites across 18 countries: United States, Belgium, Bulgaria, Canada, China, France, Germany, Greece, Italy, Japan, Latvia, Lithuania, Malaysia, Portugal, Serbia, South Korea, Spain, Thailand

Regulatory

• FDA-regulated drug study