Early IV BXOS110 versus placebo for acute ischaemic stroke within 3 hours

A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.

This trial tests whether giving BXOS110 by IV within 3 hours of symptom onset can reduce disability in adults with acute ischaemic stroke.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1112 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Biocells (Beijing) Biotech Co.,Ltd (Industry-sponsored)
• Locations: 9 sites (Hengshui, Hebei and 8 other locations)
• Trial ID: NCT07520565 on ClinicalTrials.gov

What this trial studies

This is a multicentre, randomized, double-blind, placebo-controlled Phase III trial comparing a single dose of BXOS110 (3.0 mg/kg, max 300 mg) to placebo in adults with acute ischaemic stroke. Each arm enrolls 556 participants who meet inclusion criteria, including NIHSS 8–25 and limb weakness, and who can start treatment within 3 hours of symptom onset. Patients are randomized 1:1, receive IV administration, and are evaluated immediately after dosing and at Day 2, Day 3, Day 10 or discharge, Day 30, and Day 90 for efficacy and safety outcomes. The design aims to clarify the efficacy and safety of early BXOS110 administration in reducing overall disability after stroke.

Who should consider this trial

Good fit: Adults aged 18–85 with a confirmed acute ischaemic stroke, NIHSS 8–25 with limb motor involvement, presenting and able to start IV treatment within 3 hours of symptom onset are ideal candidates.

Not a fit: Patients with haemorrhagic stroke, those presenting beyond the 3-hour window, those with very mild or very severe strokes outside the NIHSS range, or with poor pre-stroke function (mRS >1) are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, BXOS110 could reduce overall disability and improve functional recovery when given very early after an acute ischaemic stroke.

How similar studies have performed: Neuroprotective and early intervention approaches have shown mixed results historically, so this specific agent and timing remain experimental rather than proven.

Eligibility criteria

Inclusion Criteria:

1. Age18\~85 (including 18 and 85 years)，no gender limitation;
2. Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
3. 8 ≤ NIHSS score ≤ 25 before randomisation，and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ;
4. Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time);
5. First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
6. Subjects who are able to understand and comply with the study procedures, and who agree to sign the study informed consent form in writing to indicate that they are willing to participate in the trial (the informed consent form can be signed by subjects or their legal representatives).

Exclusion Criteria:

1. Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
2. Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
3. After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
4. Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
5. Heart rate \< 50 beats /min or heart rate \> 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months;
6. Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects;
7. Patients who have suffered from malignant tumors or are undergoing anti-tumor treatment within the past 5 years;
8. Patients who have been treated with neuroprotective agents after current stoke onset;
9. Have a epilepsy history or have epilepsy symptoms after current stoke onset;
10. Combined with other mental illnesses, resulting in inability or unwillingness to cooperate;
11. Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test;
12. History of severe head trauma or stroke within 3 months before screening;
13. History of severe food or drug allergy, or known allergy to the investigational drug and its excipients;
14. Expected survival period is less than 3 months;
15. Pregnant, planning pregnancy or breastfeeding patients;
16. Suspected or confirmed history of alcohol or drug abuse;
17. Participated in other drug or device clinical trial within the 1 months prior to screening or are participating in a other clinical trial;
18. Other conditions, and the investigator assessed that participation in the study might increase the patient's risk or that participation in the study was deemed inappropriate by the investigator.

Where this trial is running

Hengshui, Hebei and 8 other locations

• Harrison International Peace Hospital — Hengshui, Hebei, China (Recruiting)
• Daqing Oilfield General Hospital — Daqing, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Nanyang Medicinal College — Nanyang, Henan, China (Recruiting)
• MeiHekou Central Hospital — Meihekou, Jilin, China (Recruiting)
• The Affiliated Hospital of Shenyang Medical College — Shenyang, Liaoning, China (Recruiting)
• Xianyang Hospital of Yan'an University — Xianyang, Shaanxi, China (Recruiting)
• Linyi People's Hospital — Linyi, Shandong, China (Recruiting)
• Linfen Central Hospital — Linfen, Shanxi, China (Not_yet_recruiting)
• Beijing Tiantan Hospital , Capital Medical University — Beijing, China (Not_yet_recruiting)

Study contacts

• Study coordinator: ming xiao zhang

Conditions AIS