Recruiting
Phase 2
Phase 3

Reperfusion Optimization

Sponsor:

Corxel Pharmaceuticals

Code:

NCT06990867

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

JX10

Placebo

Study Details

Brief 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

Study ID

NCT06990867

Start date

May 15, 2025

Status verified date

Oct, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 and ≤ 90 years old.
2. Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA).
3. Radiographic evidence of salvageable tissue.
4. Pre-treatment score of NIHSS ≥ 5.

Exclusion Criteria:

1. Radiographic findings pre-randomization of any of the following:

1. Large core infarction, or
2. Occlusion in more than 1 vascular territory, or
3. Significant mass effect or clinically significant cerebral edema, or
4. Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or
5. Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.
2. Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
3. Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
4. Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count < 100,000/μL, international normalized ratio > 1.7, aPTT > 40 seconds, or prothrombin time > 15 seconds.
5. Major trauma, surgery, or invasive procedures.
6. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.
7. Pre-treatment blood glucose > 400 mg/dL (22.20 mmol/L) or Pre-treatment blood glucose < 50 mg/dL (2.78 mmol/L) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement.

Study Design

Enrollment

740 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 - JX10 (1mg/kg)

experimental: Part 1 - JX10 (3mg/kg)

placebo comparator: Part 1 - Placebo

experimental: JX10 Part 2 - (1 or 3 mg/kg)

placebo comparator: Part 2 - Placebo

Interventions

JX10

JX10 is a thrombolytic agent.

Placebo

Placebo is being used as the comparator.

Primary outcome measure

  • Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days [ Time Frame: 90 days ]
  • Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization [ Time Frame: Within 36 hours post-randomization ]

Central Contacts and Locations

Central contacts

Corxel Pharmaceuticals Study Information Center

201-268-3723Information.center@corxelbio.com

Locations

Corxel Investigational Site

Recruiting

Long Beach, California, United States, 90806

Contacts

Corxel Investigational Site

Recruiting

Sacramento, California, United States, 95817

Contacts

Corxel Investigational Site

Recruiting

Colorado Springs, Colorado, United States, 80909

Contacts

Corxel Investigational Site

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Corxel Investigational Site

Recruiting

Delray Beach, Florida, United States, 33484

Contacts

Corxel Investigational Site

Recruiting

Chicago, Illinois, United States, 60616

Corxel Investigational Site

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Corxel Investigational Site

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Corxel Investigational Site

Recruiting

Kalamazoo, Michigan, United States, 49048

Contacts

Corxel Investigational Site

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Corxel Investigational Site

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Corxel Investigational Site

Recruiting

Great Neck, New York, United States, 11021

Contacts

Corxel Investigational Site

Recruiting

New York, New York, United States, 10029

Contacts

Corxel Investigational Site

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Corxel Investigational Site

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

Corxel Investigational Site

Recruiting

Dallas, Texas, United States, 75246

Contacts

Corxel Investigational Site

Recruiting

Houston, Texas, United States, 77030

Contacts

Corxel Investigational Site

Recruiting

Edmonton, Canada

Contacts

Corxel Investigational Site

Recruiting

Kingston, Canada

Contacts

More Information

Sponsor

Corxel Pharmaceuticals

Last update posted

Mar 13, 2026

Last verified

Oct, 2025

Keywords

  • reperfusion
  • ORION
  • Acute Ischemic Stroke
  • Late Presentation
  • JX10
  • thrombolytic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Corxel Pharmaceuticals on 2026-03-13.