JX10 for Stroke

(ORION Trial)

Recruiting at 39 trial locations

Overseen By Corxel Pharmaceuticals Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Corxel Pharmaceuticals

Disqualifiers: Hypertension, Coagulopathy, Major trauma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

740 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called JX10 for individuals who have experienced an acute ischemic stroke, a type of stroke caused by a blockage in the brain's blood vessels. Researchers seek to determine if JX10 can improve recovery and reduce the risk of brain bleeding compared to a placebo. Initially, the trial will test two different doses of JX10, then proceed with the most effective dose for further testing. Individuals who have had a recent stroke, with specific symptoms and brain imaging findings, may be suitable candidates for this study. As a Phase 2, Phase 3 trial, this research will evaluate JX10's effectiveness in a larger group and represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that JX10 is likely to be safe for humans?

Research has shown that JX10 has been safe in earlier studies. In one study with 90 patients in Japan, JX10 demonstrated excellent safety results. Another study suggested that JX10 could offer more treatment options for stroke and was well-tolerated by patients. These findings indicate that JX10 is generally safe for people. However, individual experiences can differ. For those considering joining a trial, these studies provide encouraging information about the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke?

Most treatments for stroke, like clot-busting drugs (thrombolytics) or blood thinners, focus on restoring blood flow or preventing further clotting. But JX10 is different because it targets the underlying inflammation and cellular damage that occur after a stroke. This new approach could potentially minimize brain damage more effectively than current options. Researchers are excited because JX10 might not only improve recovery times but also enhance overall outcomes for stroke patients, offering a new angle in stroke treatment that could complement existing therapies.

What evidence suggests that JX10 might be an effective treatment for acute ischemic stroke?

Research has shown that JX10 could be a promising treatment for sudden strokes. Studies have found that JX10 aids recovery by breaking down blood clots and reducing swelling. In earlier trials, patients who received JX10 demonstrated better brain function than those who did not. Additionally, JX10 has been well tolerated, indicating its safety for patients. In this trial, participants will receive either JX10 or a placebo. Overall, evidence suggests that JX10 could be an effective option for people experiencing a stroke. ^{1 2 3 4 5}

Who Is on the Research Team?

Senior Director, Clinical Operations

Principal Investigator

Corxel Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for individuals who have had an Acute Ischemic Stroke (AIS) and seek treatment within 4.5 to 24 hours of the stroke occurring. Specific eligibility criteria details are not provided, but typically include factors like age, health status, and time since stroke onset.

Inclusion Criteria

I am between 18 and 90 years old.

Radiographic evidence of salvageable tissue

Pre-treatment score of NIHSS ≥ 5

Exclusion Criteria

Radiographic findings pre-randomization of large core infarction

Radiographic findings pre-randomization of occlusion in more than 1 vascular territory

Radiographic findings pre-randomization suggesting that the intracranial occlusion is chronic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants are randomized to receive JX10 (1mg/kg or 3mg/kg) or placebo

4 weeks

Treatment Part 2

Participants receive JX10 (optimal dose from Part 1) or placebo

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• JX10

Trial Overview The study tests JX10 against a placebo in two parts: initially patients receive different doses of JX10 or placebo randomly; then they get either the best dose from Part 1 or a placebo to see if it helps recovery after AIS.

How Is the Trial Designed?

Group I: Part 1 - JX10 (3mg/kg) Experimental Treatment 1 Intervention

Group II: Part 1 - JX10 (1mg/kg) Experimental Treatment 1 Intervention

Group III: JX10 Part 2 - (1 or 3 mg/kg) Experimental Treatment 1 Intervention

Group IV: Part 2 - Placebo Placebo Group 1 Intervention

Group V: Part 1 - Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Corxel Pharmaceuticals

Lead Sponsor

Trials

9

Recruited

1,500+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.048464

Anti-Inflammatory Thrombolytic JX10 (TMS-007) in Late ... Here, our data suggest potential of JX10 as a late-window thrombolytic, with observed improvements in both recanalization and functional ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39508107/

Anti-Inflammatory Thrombolytic JX10 (TMS-007) in Late ... Conclusions: JX10 was well tolerated and may expand the acute ischemic stroke therapeutic window as a novel thrombolytic agent. Registration: ...

3. tms-japan.co.jp tms-japan.co.jp/en/ir/news/auto_20241010596419/pdfFile.pdf

Publication of the Phase 2a Clinical Trial Results of JX10 ( ... The Phase 2a clinical trial of JX10 (TMS-007) was conducted in 90 patients in Japan, and achieved excellent efficacy and safety results within ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06990867

Study Details | NCT06990867 | Optimizing Reperfusion to ... JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS. Risk of symptomatic intracranial ...

5. ahajournals.org ahajournals.org/doi/10.1161/str.56.suppl_1.55

Abstract 55: A Novel Thrombolytic with Anti-inflammatory ... Despite small numbers, patients with acute lacunar infarct who were treated with JX10 showed trend of improved neurologic function at 90 days, ...