Acute Ischemic StrokePhase 2/3ORIONNCT06990867
Optimizing Reperfusion to Improve Outcomes and Neurologic Function
A Phase 2/3 study testing JX10 in people with Acute Ischemic Stroke, run by Corxel Pharmaceuticals at 104 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- JX10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 740 participants
- Where
- 104 sitesin 21 countries
- Study dates
- 15 May 2025to 31 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 90 years old.
- 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).
- Radiographic evidence of salvageable tissue.
- Pre-treatment score of NIHSS ≥ 5.
Who cannot join
- Radiographic findings pre-randomization of any of the following:
- Large core infarction, or
- Occlusion in more than 1 vascular territory, or
- Significant mass effect or clinically significant cerebral edema, or
- Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or
- Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.
Show all 12Show fewer
- Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
- Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
- 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.
- Major trauma, surgery, or invasive procedures.
- Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.
- 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.
Trial locations and contacts
104 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
104 sites in 21 countries
United States20 sites, 20 recruiting
- Recruiting
Corxel Investigational Site
Baltimore, Maryland, 21215
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Chattanooga, Tennessee, 37404
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Chicago, Illinois, 60616
Study Director
- Recruiting
Corxel Investigational Site
Colorado Springs, Colorado, 80909
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Columbus, Ohio, 43214
Corxel Investigational Site, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Dallas, Texas, 75246
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Delray Beach, Florida, 33484
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Great Neck, New York, 11021
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Houston, Texas, 77030
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Kalamazoo, Michigan, 49048
Study Director, 201-268-3723, Information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Long Beach, California, 90806
Study Director, 201-268-3723, Information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Los Angeles, California, 90048
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
New York, New York, 10029
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Sacramento, California, 95817
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
St Louis, Missouri, 63110
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Toledo, Ohio, 43606
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Traverse City, Michigan, 49684
Study Director, 201-268-3723, Information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Tulsa, Oklahoma, 74104
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Washington D.C., District of Columbia, 20007
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Wichita, Kansas, 67214
Study Director, 201-268-3723, information.center@corxelbio.com
China16 sites, 16 recruiting
- Recruiting
Corxel Investigational Site
Baotou
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Beijing
Study Director
- Recruiting
Corxel Investigational Site
Beijing
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Changchun
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Guangzhou
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site,
Harbin
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Harbin
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Kaili
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Linfen
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Nanyang
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Shanghai
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Shenyang
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Suzhou
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Weifang
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Xuzhou
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Zhangjiakou
Study Director, 201-268-3723, information.center@corxelbio.com
Japan10 sites, 10 recruiting
- Recruiting
Corxel Investigational Site
Fukuoka
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Hyōgo
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational site
Ibaraki
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Kamakura
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Meguro City
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Mitaka
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Miyagi
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational site
Toyota
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Yamagata
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Yamaguchi
Study Director, 201-268-3723, information.center@corxelbio.com
Spain9 sites, 9 recruiting
- Recruiting
Corxel Investigational Site
A Coruña
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Albacete
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Barcelona
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Girona
Study director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Madrid
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Madrid
Corxel Investigational Site, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Málaga
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Seville
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Valencia
Study Director, 201-268-3723, information.center@corxelbio.com
France6 sites, 6 recruiting
- Recruiting
Corxel Investigational site
Lille
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Nancy
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational site
Paris
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Rouen
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Toulouse
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Tours
Study Director, 201-268-3723, information.center@corxelbio.com
Bulgaria5 sites, 5 recruiting
- Recruiting
Corxel Investigational Site
Blagoevgrad
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Burgas
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Pleven
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Plovdiv
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Sofia, 1606
Study Director, 201-268-3723, information.center@corxelbio.com
Germany5 sites, 5 recruiting
- Recruiting
Corxel Investigational Site
Altenburg
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Frankfurt
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Leipzig
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Lübeck
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Trier
Study Director, 201-268-3723, information.center@corxelbio.com
Portugal5 sites, 5 recruiting
- Recruiting
Corxel Investigational Site
Almada
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Braga
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Faro
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Loures
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Matosinhos Municipality
Study Director, 201-268-3723, information.center@corxelbio.com
Greece4 sites, 4 recruiting
- Recruiting
Corxel Investigational Site
Athens
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Chaïdári
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Pátrai
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Thessaloniki
Study Director, 201-268-3723, information.center@corxelbio.com
Serbia4 sites, 4 recruiting
- Recruiting
Corxel Investigational Site
Belgrade
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Kragujevac
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Niš
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Novi Sad
Study Director, 201-268-3723, information.center@corxelbio.com
Canada3 sites, 3 recruiting
- Recruiting
Corxel Investigational Site
Edmonton
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Kingston
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Winnipeg
Study Director, 201-268-3723, information.center@corxelbio.com
Belgium2 sites, 2 recruiting
- Recruiting
Corxel Investigational Site
Ghent, 9000
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Hasselt
Study Director, 201-268-3723, information.center@corxelbio.com
Italy2 sites, 2 recruiting
- Recruiting
Corxel Investigational Site
Pavia
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Roma
Study Director, 201-268-3723, information.center@corxelbio.com
Latvia2 sites, 2 recruiting
- Recruiting
Corxel Investigational Site
Daugavpils
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Riga
Study Director, 201-268-3723, information.center@corxelbio.com
Lithuania2 sites, 2 recruiting
- Recruiting
Corxel Investigational Site
Kaunas
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Vilnius
Study Director, 201-268-3723, information.center@corxelbio.com
Thailand2 sites, 2 recruiting
- Recruiting
Corxel Investigational Site
Bangkok
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Khon Kaen
Study Director, 201-268-3723, information.center@corxelbio.com
United Kingdom2 sites, 2 recruiting
- Recruiting
Corxel Investigational Site
London
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Stoke-on-Trent
Study Director, 201-268-3723, information.center@corxelbio.com
Vietnam2 sites, 2 recruiting
- Recruiting
Corxel Investigational Site
Hanoi
Study Director, 201-268-3723, information.center@corxelbio.com
- Recruiting
Corxel Investigational Site
Ho Chi Minh City
Study Director, 201-268-3723, information.center@corxelbio.com
Hungary1 site, 1 recruiting
- Recruiting
Corxel Investigational Site
Budapest
Study Director, 201-268-3723, information.center@corxelbio.com
Malaysia1 site, 1 recruiting
- Recruiting
Corxel Investigational Site
Kuching
Study Director, 201-268-3723, information.center@corxelbio.com
South Korea1 site, 1 recruiting
- Recruiting
Corxel Investigational Site
Seoul
Study Director, 201-268-3723, information.center@corxelbio.com
About this study
Official title: 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
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:
- JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS.
- 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
- Being tested
- JX10, Placebo
- Keywords
- reperfusion, ORION, Acute Ischemic Stroke, Late Presentation, JX10, thrombolytic
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JX10Drug
JX10 is a thrombolytic agent.
PlaceboDrug
Placebo is being used as the comparator.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - JX10 (1mg/kg) | Experimental | Not described Receives: Drug: JX10 |
| Part 1 - JX10 (3mg/kg) | Experimental | Not described Receives: Drug: JX10 |
| Part 1 - Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| JX10 Part 2 - (1 or 3 mg/kg) | Experimental | Not described Receives: Drug: JX10 |
| Part 2 - Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days
Measured: 90 days
Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization
Measured: Within 36 hours post-randomization
Secondary outcomes (4)
Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days
Measured: 90 days
Proportion of participants with functional independence at 90 days
Functional independence: mRS score 0-2
Measured: 90 days
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 90 days
Incidence of major bleeding within 24 hours and 14 days of study treatment
Measured: Within 24 hours and 14 days of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start15 May 2025
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Director, Clinical Operations, Study director, Corxel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990867
- Sponsor's protocol ID
- JX10002
- Acronym
- ORION
- Status last verified
- Sep 2026
- First submitted
- 22 May 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06990867
- Acronym / sponsor ID
- ORION / JX10002
- Conditions
- Acute Ischemic Stroke
- Keywords
- reperfusion, ORION, Acute Ischemic Stroke, Late Presentation, JX10, thrombolytic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 - JX10 (1mg/kg) | Experimental | Drug: JX10 |
| Part 1 - JX10 (3mg/kg) | Experimental | Drug: JX10 |
| Part 1 - Placebo | Placebo comparator | Drug: Placebo |
| JX10 Part 2 - (1 or 3 mg/kg) | Experimental | Drug: JX10 |
| Part 2 - Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 90 years old.
- 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).
- Radiographic evidence of salvageable tissue.
- Pre-treatment score of NIHSS ≥ 5.
Key exclusion criteria (12 listed)
- Radiographic findings pre-randomization of any of the following:
- Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
- Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
- 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.
- Major trauma, surgery, or invasive procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JX10JX10 is a thrombolytic agent. | Drug | JX10 Part 2 - (1 or 3 mg/kg), Part 1 - JX10 (1mg/kg), Part 1 - JX10 (3mg/kg) |
| PlaceboPlacebo is being used as the comparator. | Drug | Part 1 - Placebo, Part 2 - Placebo |
Primary outcome
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
4 secondary outcomes
Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days
Time frame: 90 days
Proportion of participants with functional independence at 90 days
Time frame: 90 days
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 90 days
Incidence of major bleeding within 24 hours and 14 days of study treatment
Time frame: Within 24 hours and 14 days of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Senior Director, Clinical Operations study director
Corxel Pharmaceuticals
104 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing JX10 in people with Acute Ischemic Stroke, run by Corxel Pharmaceuticals at 104 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, China, Japan, Spain, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corxel Pharmaceuticals Study Information Center (201-268-3723, Information.center@corxelbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.