BXOS110 Injection in the Treatment of Acute Ischaemic Stroke

March 19, 2024 updated by: Biocells (Beijing) Biotech Co.,Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Tiantan Hospital , Capital Medical University
        • Contact:
    • Guangdong
      • Shaoguan, Guangdong, China
        • Not yet recruiting
        • Yuebei People's Hospital
        • Contact:
    • Hebei
      • Hengshui, Hebei, China
        • Not yet recruiting
        • Harrison International Peace Hospital
        • Contact:
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Daqing, Heilongjiang, China
        • Not yet recruiting
        • Daqing Oilfield General Hospital
        • Contact:
    • Henan
      • Anyang, Henan, China
        • Not yet recruiting
        • Anyang People's Hospital
        • Contact:
      • Nanyang, Henan, China
        • Not yet recruiting
        • Nanshi Hospital of Nanyang
        • Contact:
      • Nanyang, Henan, China
        • Not yet recruiting
        • Nanyang Second General Hospital
        • Contact:
      • Nanyang, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Nanyang Medicinal College
        • Contact:
    • Jilin
      • Meihekou, Jilin, China
        • Not yet recruiting
        • Meihekou Central Hospital
        • Contact:
    • Liaoning
      • Chaoyang, Liaoning, China
        • Recruiting
        • Beipiao Central Hospital
        • Contact:
      • Fuxin, Liaoning, China
        • Not yet recruiting
        • Ceneral Hospital of Mining Industry Group Fuxin
        • Contact:
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • The Affiliated Hospital of Shenyang Medical College
        • Contact:
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • The first people's hospital of Shenyang
        • Contact:
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • The People's Hospital of Liaoning Province
        • Contact:
      • Tieling, Liaoning, China
        • Not yet recruiting
        • Iron Coal General Hospital of Liaoning Health Industry Group
        • Contact:
    • Neimenggu
      • Chifeng, Neimenggu, China
        • Recruiting
        • Keshketengqi Hospital of Traditional Chinese Medicine and Mongolian Medicine
        • Contact:
    • Shaanxi
      • Xianyang, Shaanxi, China
        • Not yet recruiting
        • Xianyang Hospital of Yan'an University
        • Contact:
    • Shandong
      • Liaocheng, Shandong, China
        • Not yet recruiting
        • Liaocheng People's Hospital
        • Contact:
      • Linyi, Shandong, China
        • Not yet recruiting
        • Linyi people's hospital
        • Contact:
      • Tengzhou, Shandong, China
        • Not yet recruiting
        • Tengzhou Central People's Hospital
        • Contact:
    • Shanxi
      • Datong, Shanxi, China
        • Not yet recruiting
        • Sinopharm Tongmei General Hospital
        • Contact:
      • Linfen, Shanxi, China
        • Recruiting
        • Linfen Central Hospital
        • Contact:
      • Linfen, Shanxi, China
        • Not yet recruiting
        • Linfen People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BXOS110 high-dose group
Name:BXOS110 Dosage form:injection Dosage:3.0 mg/kg, maximum dose not exceeding 300 mg Frequency:Frequency of injection is once Duration:10±1 min
Drug: high-dose BXOS110
3.0 mg/kg, maximum dose not exceeding 300 mg，Participants received one administration by intravenous infusion.
Other Names:
  • BXOS110
Experimental: BXOS110 low-dose group
Name:BXOS110 Dosage form:injection Dosage:2.0 mg/kg, maximum dose not exceeding 300 mg Frequency:Frequency of injection is once Duration:10±1 min
Drug: low-dose BXOS110
2.0 mg/kg, maximum dose not exceeding 200 mg，Participants received one administration by intravenous infusion.
Other Names:
  • BXOS110
Placebo Comparator: Placebo control group
Dosage:0 mg/kg Frequency:Frequency of injection is once Duration:10±1 min
Drug: Placebo
Does not contain any test drug active ingredients，Participants received one administration by intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with mRS score 0-2 on day 90
Time Frame: Day 90

Modified Rankin scale The Rankin scale was devised in 1957 for assessment of stroke outcomes, and was modified in 1988 to improve its comprehensiveness.The modified version, or mRS, has since been commonly used to assess disability after a stroke.

The mRS attempts to measure functional independence, incorporating the WHO components of body function, activity, and participation. The scale is defined categorically with seven different grades: 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death.

A 1-point shift on this scale is often deemed clinically significant because of the large category sizes. Patients may use adaptive devices and still be considered independent, but the need for supervision or even minimum aid from another person is scored as dependent.
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with mRS score 0-1 on day 90
Time Frame: Day 90

The modified version, or mRS, has since been commonly used to assess disability after a stroke.

The mRS attempts to measure functional independence, incorporating the WHO components of body function, activity, and participation. The scale is defined categorically with seven different grades: 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death.

A 1-point shift on this scale is often deemed clinically significant because of the large category sizes. Patients may use adaptive devices and still be considered independent, but the need for supervision or even minimum aid from another person is scored as dependent.
Day 90
Day 90 mRS Displacement Analysis
Time Frame: Day 90

The modified version, or mRS, has since been commonly used to assess disability after a stroke.

The mRS attempts to measure functional independence, incorporating the WHO components of body function, activity, and participation. The scale is defined categorically with seven different grades: 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death.

A 1-point shift on this scale is often deemed clinically significant because of the large category sizes. Patients may use adaptive devices and still be considered independent, but the need for supervision or even minimum aid from another person is scored as dependent.
Day 90
Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge)
Time Frame: Day 10

The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination.

The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
Day 10
Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge)
Time Frame: D10

The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination.

The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
D10
Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation
Time Frame: D1~ Day 10

The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination.

The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
D1~ Day 10
Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90
Time Frame: Day 90
The BI is a scale that measures ten basic aspects of activity related to self-care and mobility. The normal score is 100, and lower scores indicate greater dependency.
Day 90
Day 90 European Five Dimensional Health Scale (EQ-5D) Score
Time Frame: Day 90
The EQ-5D is a generic HRQoL measurement with evidence of good reliability and validity in various disease populations, including stroke. The EQ-5D contains the self- reported health state profile of five dimensions (mobility, self-care, usual activity, pain/discomfort, and depression/ anxiety) and a visual analog scale (EQ-VAS) .
Day 90
Mortality due to stroke within 90 days
Time Frame: Day 90
Mortality due to stroke within 90 days
Day 90
Change in infarct volume from baseline after 24 hours of dosing
Time Frame: 24 hours after treatment
Change in infarct volume from baseline after 24 hours of dosing
24 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocells (Beijing) Biotech Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BXOS110-Ⅱ-2023-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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