Clinical trial NCT06322394: BXOS110 Injection in the Treatment of Acute Ischaemic Stroke
Official title: A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Biocells (Beijing) Biotech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke.

Detailed description: This trial was conducted in a multicentre, randomised, double-blind, placebo-parallel controlled design, with a total of three groups of 100 subjects in each of the three planned groups, namely, the BXOS110 high-dose group (3.0 mg/kg, with a maximum dose of up to 300 mg), the BXOS110 low-dose group (2.0 mg/kg, with a maximum dose of up to 200 mg) and the placebo-control group, with the aim of exploring the efficacy and safety of BXOS110 at different doses of BXOS110. efficacy and safety of BXOS110.

The trial was divided into a screening/baseline period, a treatment period and a follow-up period. In the screening/baseline phase, patients signed an informed consent form within 3 hours of stroke onset to enter the trial, and after completing the screening and procedures related to the trial, subjects who met the enrolment requirements were randomly assigned to the BXOS110 high-dose group, the BXOS110 low-dose group, or a placebo-controlled group in a ratio of 1: 1: 1. During the treatment phase, subjects were randomly grouped into groups to start the intravenous treatment, and evaluations were carried out immediately after the administration of BXOS110. immediately after administration; during the Follow-up Period, subjects were evaluated for effectiveness and safety on Day 2, Day 3, Day 10, or at discharge (whichever occurred earlier), Day 30, and Day 90 after administration.

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. 6 ≤ NIHSS score ≤ 20 before randomisation;
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, as determined by the investigators to be severe heart disease, affected participants;
6. Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects;
7. Patients who have been treated with neuroprotective agents after current stoke onset;
8. Have a epilepsy history or have epilepsy symptoms after current stoke onset;
9. Combined with other mental illnesses, resulting in inability or unwillingness to cooperate;
10. Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test;
11. History of severe head trauma or stroke within 3 months before screening;
12. History of severe food or drug allergy, or known allergy to the investigational drug and its excipients;
13. Expected survival period is less than 3 months;
14. Pregnant, planning pregnancy or breastfeeding patients;
15. Suspected or confirmed history of alcohol or drug abuse;
16. Participated in other drug or device clinical trial within the 3 months prior to screening or are participating in a other clinical trial;
17. 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.

Primary outcomes:
measure: Proportion of subjects with mRS score 0-2 on day 90
timeFrame: Day 90
Secondary outcomes:
measure: Proportion of subjects with mRS score 0-1 on day 90
timeFrame: Day 90
measure: Day 90 mRS Displacement Analysis
timeFrame: Day 90
measure: Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge)
timeFrame: Day 10
measure: Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge)
timeFrame: D10
measure: Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation
timeFrame: D1~ Day 10
measure: Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90
timeFrame: Day 90
measure: Day 90 European Five Dimensional Health Scale (EQ-5D) Score
timeFrame: Day 90
measure: Mortality due to stroke within 90 days
timeFrame: Day 90
measure: Change in infarct volume from baseline after 24 hours of dosing
timeFrame: 24 hours after treatment
Other outcomes:
Locations:
city: Shaoguan
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang People's Hospital
state: Henan
city: Nanyang
country: China
facility: Nanshi Hospital of Nanyang
state: Henan
city: Nanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medicinal College
state: Henan
city: Meihekou
country: China
facility: MeiHekou Central Hospital
state: Jilin
city: Chaoyang
country: China
facility: Beipiao Central Hospital
state: Liaoning
city: Fuxin
country: China
facility: Ceneral Hospital of Mining Industry Group Fuxin
state: Liaoning
city: Shenyang
country: China
facility: The Affiliated Hospital of Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: The First People's Hospital of Shenyang
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Tieling
country: China
facility: Iron Coal General Hospital of Liaoning Health Industry Group
state: Liaoning
city: Chifeng
country: China
facility: Keshketengqi Hospital of Traditional Chinese Medicine and Mongolian Medicine
state: Neimenggu
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
state: Shaanxi
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Tengzhou
country: China
facility: Tengzhou Central People's Hospital
state: Shandong
city: Datong
country: China
facility: Sinopharm Tongmei General Hospital
state: Shanxi
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Linfen
country: China
facility: Linfen People's Hospital
state: Shanxi
city: Beijing
country: China
facility: Beijing Tiantan Hospital , Capital Medical University
Study officials:
References: